Ignite Creation Date:
2025-12-24 @ 12:39 PM
Ignite Modification Date:
2025-12-28 @ 8:45 AM
Study NCT ID:
NCT00318461
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2006-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': "Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over 24 months of treatment', 'description': 'The safety analysis set is all randomised subjects who were exposed to at least one dose of study product.', 'eventGroups': [{'id': 'EG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)', 'otherNumAtRisk': 242, 'otherNumAffected': 132, 'seriousNumAtRisk': 242, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)', 'otherNumAtRisk': 240, 'otherNumAffected': 144, 'seriousNumAtRisk': 240, 'seriousNumAffected': 25}, {'id': 'EG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)', 'otherNumAtRisk': 242, 'otherNumAffected': 158, 'seriousNumAtRisk': 242, 'seriousNumAffected': 16}, {'id': 'EG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)', 'otherNumAtRisk': 121, 'otherNumAffected': 44, 'seriousNumAtRisk': 121, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)', 'otherNumAtRisk': 242, 'otherNumAffected': 128, 'seriousNumAtRisk': 242, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 69, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 70, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 80, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 27, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 19, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 50, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 70, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 40, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 43, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 50, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 41, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 51, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 55, 'numAffected': 32}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sympathetic nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Femoral hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Muscle disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Abscess sweat gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Wound sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung carcinoma cell type unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Malignant lymphoma unclassifiable high grade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cerebral hypoperfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Snoring', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Blood calcitonin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Penile ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arterial stenosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 240, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 242, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated A1c (HbA1c) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '236', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '234', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '0.09', 'spread': '0.09', 'groupId': 'OG003'}, {'value': '-0.98', 'spread': '0.07', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '-0.88', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin.\n\nSuperiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.15', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '-0.85', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.18', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.57', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '0.1026', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.46', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '-0.86', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A test for superiority of glimepiride+metformin to metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)', 'unitOfMeasure': 'Percentage point of total HbA1c', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '237', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-2.58', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '-2.79', 'spread': '0.23', 'groupId': 'OG002'}, {'value': '-1.51', 'spread': '0.31', 'groupId': 'OG003'}, {'value': '0.95', 'spread': '0.23', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.29', 'ciLowerLimit': '-2.16', 'ciUpperLimit': '-0.41', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-3.75', 'ciLowerLimit': '-4.48', 'ciUpperLimit': '-3.01', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0117', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.07', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '-0.19', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-3.53', 'ciLowerLimit': '-4.27', 'ciUpperLimit': '-2.79', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.8198', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.60', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-2.73', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '-2.00', 'groupDescription': 'Change in body weight from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '237', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.07', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '-2.91', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '-1.80', 'spread': '0.38', 'groupId': 'OG003'}, {'value': '0.70', 'spread': '0.29', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0378', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '-0.05', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-3.61', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '-2.72', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0185', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.23', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '-0.16', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-3.73', 'ciLowerLimit': '-4.64', 'ciUpperLimit': '-2.83', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9069', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '0.80', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-2.77', 'ciLowerLimit': '-3.67', 'ciUpperLimit': '-1.87', 'groupDescription': 'Change in body weight from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline body weight as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in body weight from baseline (week 0) to 104 weeks (end of treatment)', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '234', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-1.63', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '-1.68', 'spread': '0.15', 'groupId': 'OG002'}, {'value': '0.40', 'spread': '0.21', 'groupId': 'OG003'}, {'value': '-1.31', 'spread': '0.16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-2.09', 'ciLowerLimit': '-2.68', 'ciUpperLimit': '-1.50', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.1845', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.11', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '-1.44', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.3047', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.17', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-2.12', 'ciUpperLimit': '-0.94', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.8079', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.67', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 26 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose (FPG) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '116', 'groupId': 'OG003'}, {'value': '234', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.18', 'spread': '0.17', 'groupId': 'OG002'}, {'value': '0.75', 'spread': '0.23', 'groupId': 'OG003'}, {'value': '-0.64', 'spread': '0.17', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.93', 'ciLowerLimit': '-2.58', 'ciUpperLimit': '-1.28', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0542', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.01', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '-1.30', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0451', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '-0.01', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose t as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.55', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '-0.90', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9006', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.39', 'groupDescription': 'Change in fasting plasma glucose from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline fasting plasma glucose as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '213', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.56', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '-0.44', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '-0.44', 'spread': '0.12', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8871', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.36', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.8695', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.27', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9994', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.52', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9984', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.43', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.6201', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.70', 'groupDescription': 'Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.4831', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.60', 'groupDescription': 'Change in mean prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.\n\nMean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.', 'unitOfMeasure': 'mmol/l', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'PRIMARY', 'title': 'Change in Glycosylated A1c (HbA1c) at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '235', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}, {'value': '234', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.08', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.10', 'groupId': 'OG003'}, {'value': '-0.50', 'spread': '0.08', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.83', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.59', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.8 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.12', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.8 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.8 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.81', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.57', 'groupDescription': 'Change in HbA1c from baseline to end of treatment was at 104 weeks analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 1.2 mg+metformin was superior to placebo + metformin. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.13', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 1.2 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 1.2 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.37', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. First, it was tested whether liraglutide 0.6 mg+metformin was superior to placebo + metformin.\n\nSuperiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}, {'pValue': '0.0052', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.34', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis testing was done in a hierarchical manner. As superiority of liraglutide 0.6 mg + metformin to metformin monotherapy was established, it was investigated whether liraglutide 0.6 mg + metformin was non-inferior to glimepiride + metformin. Non-inferiority was concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0.4%.'}, {'pValue': '<0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.75', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '-0.51', 'groupDescription': 'Change in HbA1c from baseline to end of treatment at 104 weeks was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline glycosylated A1c (HbA1c) as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A test for superiority of glimepiride+metformin to placebo metformin was performed to verify assay sensitivity. Superiority was always concluded if the upper limit of the 2-sided 95% CI for the treatment difference was below 0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '215', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.13', 'groupId': 'OG002'}, {'value': '-0.20', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '-0.29', 'spread': '0.13', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.5282', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.26', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.7644', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.25', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.2063', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.14', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.2678', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.12', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9887', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.43', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9998', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.42', 'groupDescription': 'Change in prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.\n\nMean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '214', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-2.33', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '-2.57', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '-0.62', 'spread': '0.24', 'groupId': 'OG003'}, {'value': '-2.46', 'spread': '0.16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '-1.30', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9670', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.41', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.72', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '-1.07', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9368', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.64', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.06', 'ciLowerLimit': '-1.71', 'ciUpperLimit': '-0.42', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.27', 'ciUpperLimit': '1.29', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '216', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.59', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-2.10', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '-0.43', 'spread': '0.26', 'groupId': 'OG003'}, {'value': '-1.80', 'spread': '0.18', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.66', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '-0.96', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.5048', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.26', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.79', 'ciLowerLimit': '-2.49', 'ciUpperLimit': '-1.08', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.2005', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.14', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.86', 'ciUpperLimit': '-0.46', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.7871', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.76', 'groupDescription': 'Change in post prandial increments of plasma glucose from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Beta-cell Function at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '226', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.45', 'spread': '5.19', 'groupId': 'OG000'}, {'value': '20.33', 'spread': '5.34', 'groupId': 'OG001'}, {'value': '26.12', 'spread': '5.20', 'groupId': 'OG002'}, {'value': '-1.63', 'spread': '7.19', 'groupId': 'OG003'}, {'value': '24.68', 'spread': '5.25', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '27.75', 'ciLowerLimit': '7.83', 'ciUpperLimit': '47.67', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9987', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '-15.03', 'ciUpperLimit': '17.90', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0263', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '21.96', 'ciLowerLimit': '2.04', 'ciUpperLimit': '41.87', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9227', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-4.36', 'ciLowerLimit': '-20.94', 'ciUpperLimit': '12.22', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.0253', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '22.08', 'ciLowerLimit': '2.15', 'ciUpperLimit': '42.01', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9293', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '-4.23', 'ciLowerLimit': '-20.78', 'ciUpperLimit': '12.31', 'groupDescription': 'Change in HOMA-B from baseline to 26 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 26', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).', 'unitOfMeasure': 'percentage point (%point)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Change in Beta-cell Function at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '226', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'categories': [{'measurements': [{'value': '64.48', 'spread': '24.93', 'groupId': 'OG000'}, {'value': '27.30', 'spread': '25.70', 'groupId': 'OG001'}, {'value': '17.81', 'spread': '25.03', 'groupId': 'OG002'}, {'value': '-7.89', 'spread': '34.47', 'groupId': 'OG003'}, {'value': '11.25', 'spread': '25.27', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.8821', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '25.71', 'ciLowerLimit': '-69.84', 'ciUpperLimit': '121.26', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9989', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '6.56', 'ciLowerLimit': '-72.66', 'ciUpperLimit': '85.79', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.8 mg + metformin and glimepiride + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.7292', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '35.20', 'ciLowerLimit': '-60.33', 'ciUpperLimit': '130.72', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.9689', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '16.05', 'ciLowerLimit': '-63.69', 'ciUpperLimit': '95.79', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 1.2 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.1818', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '72.38', 'ciLowerLimit': '-23.15', 'ciUpperLimit': '167.90', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and placebo + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}, {'pValue': '0.2978', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Estimated treatment difference, LS Mean', 'ciPctValue': '95', 'paramValue': '53.23', 'ciLowerLimit': '-26.30', 'ciUpperLimit': '132.76', 'groupDescription': 'Change in HOMA-B from baseline to 104 weeks of treatment was analyzed using an analysis of covariance (ANCOVA) model with treatment, country and previous anti-diabetic treatment as fixed effects and baseline value as covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% CI for the treatment difference between liraglutide 0.6 mg + metformin and glimepirde + metfomine was calculated. If the upper limit of the 95% CI was below 0%, it was concluded that the given dose of liraglutide in combination with metformin was better than the comparator therapy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'week 0, week 104', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).', 'unitOfMeasure': 'percentage point (%point)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat (ITT) analysis set using LOCF (Last Observation Carried Forward) is all randomised subjects who had been exposed to at least one dose of the study products.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '242', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'title': 'Major', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '136', 'groupId': 'OG004'}]}]}, {'title': 'Symptoms only', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '175', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 0-26', 'description': 'Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes at Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '121', 'groupId': 'OG003'}, {'value': '242', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'OG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'classes': [{'title': 'All', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '524', 'groupId': 'OG004'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '284', 'groupId': 'OG004'}]}]}, {'title': 'Symptoms only', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '240', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 0-104', 'description': 'Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.', 'unitOfMeasure': 'episodes', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set is all randomised subjects who were exposed to at least one dose of study product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'FG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'FG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'FG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'FG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}], 'periods': [{'title': 'Double-Blind, 6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomised', 'groupId': 'FG000', 'numSubjects': '242'}, {'comment': 'Randomised', 'groupId': 'FG001', 'numSubjects': '241'}, {'comment': 'Randomised', 'groupId': 'FG002', 'numSubjects': '242'}, {'comment': 'Randomised', 'groupId': 'FG003', 'numSubjects': '122'}, {'comment': 'Randomised', 'groupId': 'FG004', 'numSubjects': '244'}]}, {'type': 'Exposed to Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'comment': 'Subject withdrew before exposure to drug, and thus not included in the safety and ITT analysis sets', 'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '242'}, {'comment': 'Subject withdrew before exposure to drug, and thus not included in the safety and ITT analysis sets', 'groupId': 'FG003', 'numSubjects': '121'}, {'comment': 'Subjects withdrew before exposure to drug, and thus not included in the safety and ITT analysis sets', 'groupId': 'FG004', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '210'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '51'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '29'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Poor compliance/Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Subject decision/No wish to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Move', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Tendency to low blood glucose levels', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'FPG exceeds limits/too high', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Work commitment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Hypoglycaemia/Hypoglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Hyperglicaemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'metformin titrated <1500 mg or >2000 mg', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Fear of experiencing AE again', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Extension, 18 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '208'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '191'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '210'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '137'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '31'}, {'groupId': 'FG004', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '73'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '97'}]}], 'dropWithdraws': [{'type': 'Withdrawals between 6 and 24 months', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '63'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 170 centres in 21 countries: Argentina (4), Australia (19), Belgium (6), Bulgaria (1), Germany (33), Denmark (9), Spain (14), United Kingdom (11), Croatia (2), Hungary (5), Ireland (4), India (5), Italy (10), The Netherlands (5), New Zealand (3), Norway (8), Romania (3), Russia (6), Sweden (8), Slovakia (7) and South Africa (7)', 'preAssignmentDetails': 'Eligible subjects discontinued their oral anti-diabetic drug treatment and commenced a 3-week period of forced titration of metformin followed by a 3-week maintenance period. Subjects on current metformin therapy could go through a modified titration period or advance directly to the 3-week maintenance period at the discretion of the investigator.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '242', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '242', 'groupId': 'BG004'}, {'value': '1087', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'BG001', 'title': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'BG002', 'title': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'BG003', 'title': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'BG004', 'title': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '57.2', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '56.8', 'spread': '9.4', 'groupId': 'BG002'}, {'value': '56.0', 'spread': '9.4', 'groupId': 'BG003'}, {'value': '57.3', 'spread': '8.8', 'groupId': 'BG004'}, {'value': '56.7', 'spread': '9.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '103', 'groupId': 'BG004'}, {'value': '454', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}, {'value': '633', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '214', 'groupId': 'BG004'}, {'value': '946', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous anti-diabetic treatment', 'classes': [{'title': 'Mono-therapy', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '384', 'groupId': 'BG005'}]}]}, {'title': 'Combination therapy', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}, {'value': '703', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '31.1', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '4.6', 'groupId': 'BG002'}, {'value': '31.6', 'spread': '4.4', 'groupId': 'BG003'}, {'value': '31.2', 'spread': '4.6', 'groupId': 'BG004'}, {'value': '31.0', 'spread': '4.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '6.8', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '6.0', 'groupId': 'BG003'}, {'value': '7.7', 'spread': '5.3', 'groupId': 'BG004'}, {'value': '7.4', 'spread': '5.2', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis of diabetes', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '8.4', 'spread': '1.0', 'groupId': 'BG003'}, {'value': '8.4', 'spread': '0.9', 'groupId': 'BG004'}, {'value': '8.4', 'spread': '0.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated Haemoglobin at screening', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.69', 'spread': '0.10', 'groupId': 'BG000'}, {'value': '1.68', 'spread': '0.11', 'groupId': 'BG001'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG002'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG003'}, {'value': '1.69', 'spread': '0.11', 'groupId': 'BG004'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1091}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2009-11-09', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2006-04-25', 'dispFirstSubmitQcDate': '2009-11-09', 'resultsFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2006-04-25', 'dispFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-23', 'studyFirstPostDateStruct': {'date': '2006-04-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated A1c (HbA1c) at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Percentage point change in Glycosylated A1c (HbA1c) from baseline (week 0) to 26 weeks (end of randomisation)'}, {'measure': 'Change in Glycosylated A1c (HbA1c) at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in glycosylated A1c (HbA1c) baseline (week 0) to 104 weeks (end of randomisation)'}], 'secondaryOutcomes': [{'measure': 'Change in Body Weight at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Change in body weight from baseline (week 0) to 26 weeks (end of randomisation)'}, {'measure': 'Change in Body Weight at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in body weight from baseline (week 0) to 104 weeks (end of treatment)'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Change in fasting plasma glucose (FPG) from baseline (week 0) to 26 weeks (end of randomisation)'}, {'measure': 'Change in Fasting Plasma Glucose (FPG) at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in Fasting plasma glucose (FPG) from baseline (week 0) to 104 weeks (end of treatment)'}, {'measure': 'Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.\n\nMean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.'}, {'measure': 'Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in mean prandial increments of plasma glucose based on self-measured 7-point plasma glucose profiles from baseline (week 0) to 104 weeks (end of treatment). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime.\n\nMean prandial increments of plasma glucose were calculated as the sum of the plasma glucose differences between values measured before and after a meal (breakfast, lunch and dinner) divided by three.'}, {'measure': 'Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Change in mean post prandial plasma glucose from baseline (Week 0) to 26 weeks (end of randomisation). The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.'}, {'measure': 'Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in mean post prandial plasma glucose from baseline (Week 0) to 104 weeks (end of treatment) The 7 time points for self-measurements were: before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime. Mean post prandial plasma glucose were calculated as the sum of the post pradial plasma glucose values divided by three.'}, {'measure': 'Change in Beta-cell Function at Week 26', 'timeFrame': 'week 0, week 26', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).'}, {'measure': 'Change in Beta-cell Function at Week 104', 'timeFrame': 'week 0, week 104', 'description': 'Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B).\n\nBeta-cell function: HOMA-B (%) = 20∙fasting insulin\\[uU/mL\\] divided by (FPG mmol/L\\]-3.5).'}, {'measure': 'Hypoglycaemic Episodes at Week 26', 'timeFrame': 'weeks 0-26', 'description': 'Total number of hypoglycaemic episodes occuring after baseline (week 0) until week 26 (end of randomisation). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.'}, {'measure': 'Hypoglycaemic Episodes at Week 104', 'timeFrame': 'weeks 0-104', 'description': 'Total number of hypoglycaemic episodes occuring after baseline (week 0) until 104 weeks (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '18931095', 'type': 'RESULT', 'citation': 'Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.'}, {'pmid': '19245711', 'type': 'RESULT', 'citation': 'Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.'}, {'pmid': '19491535', 'type': 'RESULT', 'citation': 'Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.'}, {'pmid': '19491536', 'type': 'RESULT', 'citation': 'McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.'}, {'pmid': '19878259', 'type': 'RESULT', 'citation': 'Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.'}, {'pmid': '19930006', 'type': 'RESULT', 'citation': 'Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.'}, {'pmid': '21450987', 'type': 'RESULT', 'citation': 'Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.'}, {'pmid': '22055210', 'type': 'RESULT', 'citation': 'Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.'}, {'pmid': '22193143', 'type': 'RESULT', 'citation': 'Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.'}, {'pmid': '21883806', 'type': 'RESULT', 'citation': 'Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.'}, {'pmid': '21883438', 'type': 'RESULT', 'citation': 'Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.'}, {'pmid': '22985213', 'type': 'RESULT', 'citation': 'Nauck M, Frid A, Hermansen K, Thomsen AB, During M, Shah N, Tankova T, Mitha I, Matthews DR. Long-term efficacy and safety comparison of liraglutide, glimepiride and placebo, all in combination with metformin in type 2 diabetes: 2-year results from the LEAD-2 study. Diabetes Obes Metab. 2013 Mar;15(3):204-12. doi: 10.1111/dom.12012. Epub 2012 Oct 11.'}, {'pmid': '22862847', 'type': 'RESULT', 'citation': 'Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.'}, {'pmid': '23010561', 'type': 'RESULT', 'citation': 'Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.'}, {'pmid': '23186975', 'type': 'RESULT', 'citation': 'King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.'}, {'pmid': '25504028', 'type': 'RESULT', 'citation': 'Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.'}, {'pmid': '24561125', 'type': 'DERIVED', 'citation': 'Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.'}, {'pmid': '21209033', 'type': 'DERIVED', 'citation': 'Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months\n* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy\n* Body Mass Index (BMI) less than or equal 40 kg/m2\n\nExclusion Criteria:\n\n* Subjects treated with insulin within the last three months\n* Subjects with any serious medical condition\n* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods\n* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)"}, 'identificationModule': {'nctId': 'NCT00318461', 'acronym': 'LEAD-2', 'briefTitle': 'To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN2211-1572'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lira 0.6 + Met', 'description': 'Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day', 'interventionNames': ['Drug: liraglutide', 'Drug: metformin', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.2 + Met', 'description': 'Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day', 'interventionNames': ['Drug: metformin', 'Drug: placebo', 'Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.8 + Met', 'description': 'Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day', 'interventionNames': ['Drug: metformin', 'Drug: placebo', 'Drug: liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Met Mono', 'description': 'Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo', 'interventionNames': ['Drug: metformin', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Met + Glim', 'description': 'Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo', 'interventionNames': ['Drug: metformin', 'Drug: glimepiride', 'Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '0.6 mg for s.c. (under the skin) injection.', 'armGroupLabels': ['Lira 0.6 + Met']}, {'name': 'metformin', 'type': 'DRUG', 'description': '1.5-2.0 g tablets', 'armGroupLabels': ['Lira 0.6 + Met', 'Lira 1.2 + Met', 'Lira 1.8 + Met', 'Met + Glim', 'Met Mono']}, {'name': 'glimepiride', 'type': 'DRUG', 'description': '4 mg tablets', 'armGroupLabels': ['Met + Glim']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Glimepiride placebo 1 mg and 2 mg tablets', 'armGroupLabels': ['Lira 0.6 + Met', 'Lira 1.2 + Met', 'Lira 1.8 + Met', 'Met Mono']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Liraglutide placebo 1-3 mL for s.c. (under the skin) injection', 'armGroupLabels': ['Met + Glim', 'Met Mono']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': '1.2 mg for s.c. (under the skin) injection', 'armGroupLabels': ['Lira 1.2 + Met']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': '1.8 mg for s.c. (under the skin) injection', 'armGroupLabels': ['Lira 1.8 + Met']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1405CWB', 'city': 'Ciudad Autonoma de Bs As', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'C1426ABP', 'city': 'Ciudad Autónoma de Bs As', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'C1406FWY', 'city': 'Ciudad Autónoma de BsAs', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '6000', 'city': 'Junín', 'country': 'Argentina', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.59391, 'lon': -60.94644}}, {'zip': '2292', 'city': 'Broadmeadow', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'zip': '2751', 'city': 'Penrith', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.75, 'lon': 150.7}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '5041', 'city': 'Daw Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.98975, 'lon': 138.58407}}, {'zip': '3135', 'city': 'East Ringwood', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '6160', 'city': 'Fremantle', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -32.05632, 'lon': 115.74557}}, {'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': 'SA 5035', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'city': 'Auckland', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '2200', 'city': 'Bankstown', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.91667, 'lon': 151.03333}}, {'zip': '3128', 'city': 'Box Hill', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '4870', 'city': 'Cairns', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}, {'zip': '2050', 'city': 'Camperdown', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '3168', 'city': 'Clayton', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3065', 'city': 'Fitzroy', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '2605', 'city': 'Garran', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2077', 'city': 'Hornsby', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.70244, 'lon': 151.09931}}, {'zip': '3144', 'city': 'Malvern', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'zip': '6000', 'city': 'Perth', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2145', 'city': 'Westmead', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '5011', 'city': 'Woodville', 'country': 'Australia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'zip': '6700', 'city': 'Arlon', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.68333, 'lon': 5.81667}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4500', 'city': 'Huy', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.51894, 'lon': 5.23284}}, {'zip': '7100', 'city': 'La Louvière', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.48657, 'lon': 4.18785}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Århus C', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '9800', 'city': 'Hjørring', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 57.46417, 'lon': 9.98229}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '2300', 'city': 'København S', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.65059, 'lon': 12.5978}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Viborg', 'country': 'Denmark', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '83670', 'city': 'Bad Heilbrunn', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.74671, 'lon': 11.45934}}, {'zip': '55545', 'city': 'Bad Kreuznach', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.8414, 'lon': 7.86713}}, {'zip': '37431', 'city': 'Bad Lauterberg im Harz', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.63272, 'lon': 10.47031}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '53474', 'city': 'Bad Neuenahr-Ahrweiler', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.54322, 'lon': 7.1113}}, {'zip': '59269', 'city': 'Beckum', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.75571, 'lon': 8.04075}}, {'zip': '64625', 'city': 'Bensheim', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.68369, 'lon': 8.61839}}, {'zip': '10115', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12687', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50858', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '64283', 'city': 'Darmstadt', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.87167, 'lon': 8.65027}}, {'zip': '65582', 'city': 'Diez', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.37419, 'lon': 8.00735}}, {'zip': '41539', 'city': 'Dormagen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.09683, 'lon': 6.83167}}, {'zip': '01219', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '24939', 'city': 'Flensburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.78805, 'lon': 9.43722}}, {'zip': '96269', 'city': 'Großheirath', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.17603, 'lon': 10.9505}}, {'zip': '06114', 'city': 'Halle', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '21073', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22607', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '27449', 'city': 'Kutenholz-Mulsum', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '67059', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '56564', 'city': 'Neuwied', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.4336, 'lon': 7.47057}}, {'zip': '46145', 'city': 'Oberhausen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': '01796', 'city': 'Pirna', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.95843, 'lon': 13.93702}}, {'zip': '35415', 'city': 'Pohlheim', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '93059', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '66780', 'city': 'Rehlingen-Siersburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.37565, 'lon': 6.68439}}, {'zip': '83416', 'city': 'Saaldorf', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.86873, 'lon': 12.92834}}, {'zip': '66121', 'city': 'Saarbrücken', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.23262, 'lon': 7.00982}}, {'zip': '66386', 'city': 'Saint Ingbert', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '67346', 'city': 'Speyer', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}, {'zip': '70184', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '92237', 'city': 'Sulzbach-Rosenberg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.50126, 'lon': 11.74598}}, {'zip': '72072', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '41751', 'city': 'Viersen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.25435, 'lon': 6.39441}}, {'zip': '66333', 'city': 'Völklingen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.25162, 'lon': 6.85873}}, {'zip': '97072', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1041', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4043', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '5700', 'city': 'Gyula', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.65, 'lon': 21.28333}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7631', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '8900', 'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '500082', 'city': 'Hyderabad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '682041', 'city': 'Kochi', 'state': 'Kerala', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'zip': '400012', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '600086', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '560034', 'city': 'Bangalore', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': 'DUBLIN 15', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'DUBLIN 7', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': 'DUBLIN 8', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Waterford', 'country': 'Ireland', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.25833, 'lon': -7.11194}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '95126', 'city': 'Catania', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '50141', 'city': 'Florence', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '10043', 'city': 'Orbassano', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '47900', 'city': 'Rimini', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07100', 'city': 'Sassari', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '10154', 'city': 'Torino', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '9728 NT', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3045 PM', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3361 XV', 'city': 'Sliedrecht', 'country': 'Netherlands', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.82083, 'lon': 4.77639}}, {'zip': '1357', 'city': 'Bekkestua', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'NO-5012', 'city': 'Bergen', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '2408', 'city': 'Elverum', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.88191, 'lon': 11.56231}}, {'zip': 'NO-2819', 'city': 'Gjøvik', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.79574, 'lon': 10.69155}}, {'zip': '2317', 'city': 'Hamar', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.7945, 'lon': 11.06798}}, {'zip': 'NO-3602', 'city': 'Kongsberg', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.66858, 'lon': 9.65017}}, {'zip': '2212', 'city': 'Kongsvinger', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.19049, 'lon': 11.99772}}, {'zip': '4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': 'NO-7030', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}, {'zip': '400006', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '900591', 'city': 'Constanța', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'zip': '700111', 'city': 'Iași', 'country': 'Romania', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'zip': '117036', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127486', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129090', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '198013', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '83 299', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '831 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '833 05', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04-001', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '045 01', 'city': 'Moldava nad Bodvou', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.61428, 'lon': 20.99957}}, {'zip': '080 01', 'city': 'Prešov', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'zip': '91 101', 'city': 'Trenčín', 'country': 'Slovakia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'zip': '1829', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '27 11', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4091', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '4092', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '7130', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '1500', 'city': 'Benoni', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.18848, 'lon': 28.32078}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '13600', 'city': 'Alcázar de San Juan', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.39011, 'lon': -3.20827}}, {'zip': '04001', 'city': 'Almería', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '11009', 'city': 'Cadiz', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '06800', 'city': 'Mérida', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.91802, 'lon': -6.34292}}, {'zip': '38320', 'city': 'San Cristóbal de La Laguna', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'zip': '03550', 'city': 'San Juan', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.53333, 'lon': -1.16667}}, {'zip': '38010', 'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '791 82', 'city': 'Falun', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}, {'zip': '651 85', 'city': 'Karlstad', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.3793, 'lon': 13.50357}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '118 83', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': 'NP7 7EG', 'city': 'Abergavenny', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.82098, 'lon': -3.01743}}, {'zip': 'BA1 2SR', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'BA2 1NH', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'RG7 3SQ', 'city': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': 'CF23 8SQ', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CV2 2DX', 'city': 'Coventry', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'KT24 6QT', 'city': 'East Horsley', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.27358, 'lon': -0.43207}}, {'zip': 'BA11 1EZ', 'city': 'Frome', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.22834, 'lon': -2.32211}}, {'zip': 'SA14 8QF', 'city': 'Llanelli', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.68195, 'lon': -4.16191}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'PL6 8BQ', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'S3 9DA', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'TW16 6RH', 'city': 'Sunbury-on-Thames', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.40424, 'lon': -0.41817}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}