Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-29 @ 9:16 PM
Study NCT ID:
NCT01272232
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk reserves the right not to release data until specified milestones are available. This includes the right not to release interim results from clinical trials, as such results may lead to conclusions that are later proven incorrect. At the end of the trial, one or more manuscripts for publication will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to briefly postpone publication or communication to protect intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded for up to 68 weeks.', 'description': 'Safety Analysis Set comprising all randomised subjects who had been exposed to at least one dose of trial product.', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.', 'otherNumAtRisk': 422, 'otherNumAffected': 361, 'seriousNumAtRisk': 422, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.', 'otherNumAtRisk': 210, 'otherNumAffected': 173, 'seriousNumAtRisk': 210, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.', 'otherNumAtRisk': 212, 'otherNumAffected': 164, 'seriousNumAtRisk': 212, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 34, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 78, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 173, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 50, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 35, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 59, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 208, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 84, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 34, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 113, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 45, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 33, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 134, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 46, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 54, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 49, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 34, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 56, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 44, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 981, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 429, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 154, 'numAffected': 59}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 67, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 39, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 125, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 42, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 40, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Meniere', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ulcerative keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthritis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood calcitonin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pancreatic enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperlipasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tendon disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 422, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change (%) From Baseline in Body Weight (Fasting)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '-4.6', 'spread': '5.5', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-3.97', 'ciLowerLimit': '-4.84', 'ciUpperLimit': '-3.11', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-2.62', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '-1.62', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-1.35', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '-0.48', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 56', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'PRIMARY', 'title': 'Proportion of Subjects Losing at Least 5% of Baseline Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '49.9', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}, {'value': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '50.1', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}, {'value': '86.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '6.81', 'ciLowerLimit': '4.34', 'ciUpperLimit': '10.68', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '2.24', 'ciUpperLimit': '6.09', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '1.29', 'ciUpperLimit': '2.64', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at 56 weeks', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'PRIMARY', 'title': 'Proportion of Subjects Losing More Than 10% of Baseline Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '14.4', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '76.6', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}, {'value': '95.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '7.10', 'ciLowerLimit': '3.48', 'ciUpperLimit': '14.48', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0008', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '3.84', 'ciLowerLimit': '1.75', 'ciUpperLimit': '8.41', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.85', 'ciLowerLimit': '1.16', 'ciUpperLimit': '2.95', 'pValueComment': 'Superiority was established only if all preceding hypotheses had been rejected. p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'The 3 co-primary endpoints (Outcome Measures 1, 2 and 3) were ranked (#1, 2, 3); hypotheses of no difference were tested in a hierarchical manner. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at 56 weeks', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.78', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.57', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '-0.04', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 56', 'description': 'Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.', 'unitOfMeasure': 'percentage point change of HbA1c', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Reaching Target HbA1c Below 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '27.2', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '72.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '8.79', 'ciLowerLimit': '5.74', 'ciUpperLimit': '13.4', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '7.71', 'ciLowerLimit': '4.76', 'ciUpperLimit': '12.51', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.5319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.71', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at 56 weeks', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000'}, {'value': '45.6', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000'}, {'value': '54.4', 'groupId': 'OG001'}, {'value': '85.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '9.61', 'ciLowerLimit': '6.05', 'ciUpperLimit': '15.26', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '5.98', 'ciLowerLimit': '3.59', 'ciUpperLimit': '9.97', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0142', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.10', 'ciUpperLimit': '2.34', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'at 56 weeks', 'unitOfMeasure': 'percentage of subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}, {'value': '211', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-3.22', 'ciLowerLimit': '-4.20', 'ciUpperLimit': '-2.23', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-2.06', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '-0.92', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-2.16', 'ciUpperLimit': '-0.16', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 56', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change (%) From Baseline in Body Weight (Fasting)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.7', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '5.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-2.17', 'ciLowerLimit': '-3.32', 'ciUpperLimit': '-1.02', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0725', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-2.51', 'ciUpperLimit': '0.11', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '0.09', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 68', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change (%) From Week 56 to 68 in Body Weight (Fasting)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56, week 68', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.7', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '6.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-2.49', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '-1.24', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0457', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-1.47', 'ciLowerLimit': '-2.92', 'ciUpperLimit': '-0.03', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0961', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment contrast', 'ciPctValue': '95', 'paramValue': '-1.02', 'ciLowerLimit': '-2.22', 'ciUpperLimit': '0.18', 'pValueComment': 'p values are 2-sided; 5% pre-defined significance level.', 'groupDescription': 'Test of no difference. Fixed factors: treatment, country, sex, background treatment, baseline HbA1c stratum, background treatment/HbA1c-stratum-interaction; covariate: baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, week 68', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Week 56 to 68 in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.21', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '3.55', 'groupId': 'OG001'}, {'value': '-0.22', 'spread': '3.23', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 56, week 68', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Last Observation Carried Forward (LOCF) data. Full analysis set, comprising all randomised subjects who had been exposed to at least 1 dose of trial product and with at least 1 post-randomisation assessment of any efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'OG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'classes': [{'title': 'Minor', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Documented, symptomatic', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Asymptomatic', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Probable, symptomatic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Relative', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'ADA: Unclassifiable', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-56', 'description': 'Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L \\[50 mg/dL\\] or plasma glucose level below 3.1 mmol/L \\[56 mg/dL\\]).', 'unitOfMeasure': 'Episodes/100 years of patient exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set, comprising all randomised subjects who had been exposed to at least one dose of trial product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'FG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'FG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}], 'periods': [{'title': 'Weeks 0-56', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '423'}, {'groupId': 'FG001', 'numSubjects': '211'}, {'groupId': 'FG002', 'numSubjects': '212'}]}, {'type': 'Exposed', 'achievements': [{'comment': '1 subject dropped out after randomisation and before exposure to trial drug.', 'groupId': 'FG000', 'numSubjects': '422'}, {'comment': '1 subject dropped out after randomisation and before exposure to trial drug.', 'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '212'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}]}]}, {'title': 'Off Drug Follow-up Period (Weeks 56-68)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '324'}, {'groupId': 'FG001', 'numSubjects': '164'}, {'groupId': 'FG002', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Unclassified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 126 sites in 9 countries participated: France (7), Germany (10), Israel (5), South Africa (6), Spain (8), Sweden (5), Turkey (3), United Kingdom (15), United States (67).', 'preAssignmentDetails': 'If eligible based on screened assessments, subjects were randomised to 1 of the 3 treatment arms in a 2:1:1 manner (liraglutide 3.0 mg, liraglutide 1.8 mg and placebo, respectively).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '423', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}, {'value': '846', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide 3.0 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'BG001', 'title': 'Liraglutide 1.8 mg', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'BG002', 'title': 'Liraglutide Placebo', 'description': 'Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.0', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '54.9', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '421', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '425', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '756', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}, {'value': '705', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age group', 'classes': [{'title': '18- < 40 years', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': '40- < 65 years', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '623', 'groupId': 'BG003'}]}]}, {'title': '65- < 75 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting body weight', 'classes': [{'categories': [{'measurements': [{'value': '105.7', 'spread': '21.9', 'groupId': 'BG000'}, {'value': '105.8', 'spread': '21.0', 'groupId': 'BG001'}, {'value': '106.5', 'spread': '21.3', 'groupId': 'BG002'}, {'value': '105.9', 'spread': '21.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '1.69', 'spread': '0.11', 'groupId': 'BG000'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG001'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG002'}, {'value': '1.69', 'spread': '0.10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Height was recorded without shoes.', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '37.0', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '37.4', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '37.1', 'spread': '6.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI) group', 'classes': [{'title': '25.0-29.9 kg/m^2 - pre-obese', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': '30.0-34.9 kg/m^2 - obese class I', 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}]}, {'title': '35.0-39.9 kg/m^2 - obese class II', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '218', 'groupId': 'BG003'}]}]}, {'title': '>40.0 kg/m^2 - obese class III', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '252', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c (glycosylated haemoglobin)', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '7.9', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent (%) glycosylated haemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting plasma glucose', 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '8.8', 'spread': '1.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Co-morbid hypertension', 'classes': [{'title': 'Present', 'categories': [{'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}, {'value': '586', 'groupId': 'BG003'}]}]}, {'title': 'Absent', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Presence or absence of untreated or treated hypertension', 'unitOfMeasure': 'participants'}, {'title': 'Co-morbid dyslipidaemia', 'classes': [{'title': 'Present', 'categories': [{'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '564', 'groupId': 'BG003'}]}]}, {'title': 'Absent', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '282', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Presence or absence of untreated or treated dyslipidaemia', 'unitOfMeasure': 'participants'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '7.54', 'spread': '5.65', 'groupId': 'BG000'}, {'value': '7.43', 'spread': '5.16', 'groupId': 'BG001'}, {'value': '6.71', 'spread': '5.07', 'groupId': 'BG002'}, {'value': '7.30', 'spread': '5.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', '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': 846}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'dispFirstSubmitDate': '2014-01-24', 'completionDateStruct': {'date': '2013-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2011-01-06', 'dispFirstSubmitQcDate': '2014-01-24', 'resultsFirstSubmitDate': '2015-01-22', 'studyFirstSubmitQcDate': '2011-01-06', 'dispFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change (%) From Baseline in Body Weight (Fasting)', 'timeFrame': 'Week 0, week 56', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.'}, {'measure': 'Proportion of Subjects Losing at Least 5% of Baseline Body Weight', 'timeFrame': 'at 56 weeks', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.'}, {'measure': 'Proportion of Subjects Losing More Than 10% of Baseline Body Weight', 'timeFrame': 'at 56 weeks', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.'}], 'secondaryOutcomes': [{'measure': 'Change (%-Points) From Baseline in HbA1c (Glycosylated Haemoglobin A1c)', 'timeFrame': 'Week 0, week 56', 'description': 'Change in HbA1c (%-points) was calculated as the difference between the HbA1c (%) at Week 0 and Week 56.'}, {'measure': 'Proportion of Subjects Reaching Target HbA1c Below 7%', 'timeFrame': 'at 56 weeks'}, {'measure': 'Proportion of Subjects Reaching Target HbA1c Below or Equal to 6.5%', 'timeFrame': 'at 56 weeks'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Week 0, week 56'}, {'measure': 'Change (%) From Baseline in Body Weight (Fasting)', 'timeFrame': 'Week 0, week 68', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.'}, {'measure': 'Change (%) From Week 56 to 68 in Body Weight (Fasting)', 'timeFrame': 'Week 56, week 68', 'description': 'Weight was recorded to the nearest 0.1 kg for a subject in the fasting state with an empty bladder, without shoes and only wearing light clothing. The same calibrated scale was used throughout the trial.'}, {'measure': 'Change From Baseline in Waist Circumference', 'timeFrame': 'Week 0, week 68'}, {'measure': 'Change From Week 56 to 68 in Waist Circumference', 'timeFrame': 'Week 56, week 68'}, {'measure': 'Incidence of Hypoglycaemic Episodes', 'timeFrame': 'Weeks 0-56', 'description': 'Hypoglycaemic episodes were classified according to American Diabetes Association (ADA) definitions as well as to the Novo Nordisk definition of a minor hypoglycaemic event (blood glucose level below approximately 2.8 mmol/L \\[50 mg/dL\\] or plasma glucose level below 3.1 mmol/L \\[56 mg/dL\\]).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metabolism and Nutrition Disorder', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '29145215', 'type': 'BACKGROUND', 'citation': 'le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.'}, {'pmid': '27193270', 'type': 'RESULT', 'citation': 'Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.'}, {'pmid': '27482610', 'type': 'RESULT', 'citation': "O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2."}, {'pmid': '27804269', 'type': 'RESULT', 'citation': "Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629."}, {'pmid': '27817208', 'type': 'RESULT', 'citation': 'Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.'}, {'pmid': '26744025', 'type': 'RESULT', 'citation': 'Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.'}, {'pmid': '26833744', 'type': 'RESULT', 'citation': 'Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.'}, {'pmid': '26284720', 'type': 'RESULT', 'citation': 'Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjoth TV, Andreasen AH, Jensen CB, DeFronzo RA; NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):687-99. doi: 10.1001/jama.2015.9676.'}, {'pmid': '26418188', 'type': 'RESULT', 'citation': 'McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.'}, {'pmid': '28473337', 'type': 'RESULT', 'citation': 'Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4.'}, {'pmid': '28462892', 'type': 'RESULT', 'citation': 'von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.'}, {'pmid': '28386912', 'type': 'RESULT', 'citation': "O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21."}, {'pmid': '28950422', 'type': 'RESULT', 'citation': 'Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': "This trial is conducted in Africa, Asia, Europe and the United States of America (USA).\n\nThe aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \\[SU\\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained\n* Subjects diagnosed with type 2 diabetes and treated with either diet and exercise alone, metformin, sulphonylurea, glitazone as single agent therapy or a combination of the previously mentioned compounds\n* HbA1c 7.0-10.0% (both inclusive)\n* Body Mass Index (BMI) at least 27.0 kg/m\\^2\n* Stable body weight\n* Preceding failed dietary effort\n\nExclusion Criteria:\n\n* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months\n* Known proliferative retinopathy or maculopathy\n* History of acute or chronic pancreatitis\n* Obesity induced by drug treatment\n* Use of approved weight lowering pharmacotherapy\n* Previous surgical treatment of obesity\n* History of major depressive disorder or suicide attempt\n* Uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)\n* Screening calcitonin of 50 ng/L or above\n* Familial or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)\n* Personal history of non-familial medullary thyroid carcinoma'}, 'identificationModule': {'nctId': 'NCT01272232', 'briefTitle': 'Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: SCALE™ - Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period', 'orgStudyIdInfo': {'id': 'NN8022-1922'}, 'secondaryIdInfos': [{'id': '2008-002199-88', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1118-7963', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lira 3.0 mg', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Lira 1.8 mg', 'interventionNames': ['Drug: liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': 'Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.', 'armGroupLabels': ['Lira 3.0 mg']}, {'name': 'liraglutide', 'type': 'DRUG', 'description': 'Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.', 'armGroupLabels': ['Lira 1.8 mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Vestavia Hills', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.44872, 'lon': -86.78777}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '91978', 'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'zip': '92780', 'city': 'Tustin', 'state': 'California', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.74585, 'lon': -117.82617}}, {'zip': '80005', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.80276, 'lon': -105.08748}}, {'zip': '34601', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30318', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30076', 'city': 'Roswell', 'state': 'Georgia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.02316, 'lon': -84.36159}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83642', 'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611-5975', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62711', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '48034-7661', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08648', 'city': 'Lawrenceville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.29733, 'lon': -74.7296}}, {'zip': '08755-8050', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '28557', 'city': 'Morehead City', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.72294, 'lon': -76.72604}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45255', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45439', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29621', 'city': 'Anderson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 34.50344, 'lon': -82.65013}}, {'zip': '29461', 'city': 'Moncks Corner', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 33.19632, 'lon': -80.01429}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37411', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78728', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78207-5209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84790', 'city': 'St. George', 'state': 'Utah', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.10415, 'lon': -113.58412}}, {'zip': '23606', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}, {'zip': '93143', 'city': 'Bondy', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '17019', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '71200', 'city': 'Le Creusot', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 46.80714, 'lon': 4.41632}}, {'zip': '92014', 'city': 'Nanterre', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.89198, 'lon': 2.20675}}, {'zip': '11108', 'city': 'Narbonne', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.18396, 'lon': 3.00141}}, {'zip': '97139', 'city': 'Pointe à Pitre', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.07984, 'lon': 1.98937}}, {'zip': '44800', 'city': 'Saint-Herblain', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '69200', 'city': 'Vénissieux', 'country': 'France', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.69706, 'lon': 4.88593}}, {'zip': '12157', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12163', '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': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '01309', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '57580', 'city': 'Gebhardshain', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.75, 'lon': 7.81667}}, {'zip': '22607', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '06679', 'city': 'Hohenmölsen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.15769, 'lon': 12.1}}, {'zip': '48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '04435', 'city': 'Schkeuditz', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.39678, 'lon': 12.22141}}, {'zip': '70378', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '88239', 'city': 'Wangen', 'country': 'Germany', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 47.6895, 'lon': 9.83247}}, {'zip': '302006', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '600086', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '700020', 'city': 'Kolkata', 'state': 'West Bengal', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '411011', 'city': 'Pune', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '695 032', 'city': 'Thriruvananthapuram', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '35152', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '75650', 'city': 'Rishon LeZiyyon', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 31.97102, 'lon': 34.78939}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '66100', 'city': 'Chieti Scalo', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '50141', 'city': 'Florence', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '47100', 'city': 'Forlì', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 44.22177, 'lon': 12.04144}}, {'zip': '04100', 'city': 'Latina', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.46614, 'lon': 12.9043}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '35143', 'city': 'Padua', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '06126', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}, {'zip': '51100', 'city': 'Pistoia', 'country': 'Italy', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 43.93064, 'lon': 10.92365}}, {'zip': '00921', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '6045', 'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '9301', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '2194', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '1827', 'city': 'Lenasia', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -26.32052, 'lon': 27.83564}}, {'zip': '0001', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '4001', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '0250', 'city': 'Brits', 'state': 'North West', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -25.63473, 'lon': 27.78022}}, {'zip': '7460', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7708', 'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '07010', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '03114', 'city': 'Partida de Bacarot', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site'}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41010', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '262 81', 'city': 'Ängelholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 56.2428, 'lon': 12.86219}}, {'zip': '240 10', 'city': 'Dalby', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.66655, 'lon': 13.34976}}, {'zip': '416 65', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '417 17', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '972 33', 'city': 'Luleå', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '701 85', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}, {'zip': '112 81', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '710', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '27070', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}, {'zip': '31040', 'city': 'Hatay', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.40227, 'lon': 27.10486}}, {'zip': '34096', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35340', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '46000', 'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}, {'zip': 'ML6 0JS', 'city': 'Airdrie', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.86602, 'lon': -3.98025}}, {'zip': 'KA6 6DX', 'city': 'Ayr', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 55.46273, 'lon': -4.63393}}, {'zip': 'TN39 4SP', 'city': 'Bexhill-on-Sea', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.85023, 'lon': 0.47095}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS10 5NB', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CH2 1UL', 'city': 'Chester', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.1905, 'lon': -2.89189}}, {'zip': 'DL2 1AA', 'city': 'Darlington', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.52429, 'lon': -1.55039}}, {'zip': 'LS25 1AN', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'E1 2EF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'PL6 8BQ', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'zip': 'S651DA', 'city': 'Rotherham', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'SA6 6NL', 'city': 'Swansea', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 51.62079, 'lon': -3.94323}}, {'zip': 'TR1 3LJ', 'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}], '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'}}}}