Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00393718
Status:
COMPLETED
Last Update Posted:
2017-03-08
First Post:
2006-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D005905', 'term': 'Glyburide'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@novonordisk.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': "Novo Nordisk acknowledges the Investigator's right to publish the entire results of the trial. Any such scientific paper, presentation, communication or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected in a time span over 52 weeks.', 'description': 'The safety analysis population consists of all subjects exposed to study drug (Full Analysis Set, FAS).', 'eventGroups': [{'id': 'EG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo', 'otherNumAtRisk': 268, 'otherNumAffected': 172, 'seriousNumAtRisk': 268, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo', 'otherNumAtRisk': 132, 'otherNumAffected': 91, 'seriousNumAtRisk': 132, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 183, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 94, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 31, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 48, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Ventriculoperitoneal shunt malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Blood creatine phosphokinase MB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Spinal ligament ossification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neurogenic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Colon polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6.99', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.30', 'pValueComment': 'p-value is for the null hypothesis for superiority. A significance level of a one-sided 2.5% was used for statistical hypothesis testing.', 'groupDescription': 'ANOVA model included HbA1C at baseline as a covariate and treatment group and pre-trial treatment as fixed effects.\n\nHypothesis for non-inferiority:\n\nH0: μ0.9 - μG ≥ 0.4, H1: μ0.9 - μG \\< 0.4,\n\nHypothesis for superiority:\n\nH0: μ0.9 - μG ≥ 0.0, H1: μ0.9 - μG \\< 0.0, where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively. When non-inferiority was confirmed, superiority was evaluated based on the closed testing procedure.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.4%. Superiority criterion: Upper limit of confidence interval of mean difference(= Liraglutide - Glibenclamide) is less than 0.0%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.31', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '7.80', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.27', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'unitOfMeasure': 'percentage of total haemoglobin', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '137.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '150.1', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-12.9', 'ciLowerLimit': '-18.2', 'ciUpperLimit': '-7.5', 'pValueComment': 'A significance level of a two-sided 5% was used for statistical hypothesis testing.', 'groupDescription': 'The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Fasting Plasma Glucose After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '145.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '157.5', 'spread': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-11.7', 'ciLowerLimit': '-18.6', 'ciUpperLimit': '-4.9', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Postprandial Glucose AUC After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '557.54', 'spread': '9.53', 'groupId': 'OG000'}, {'value': '670.60', 'spread': '12.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-93.05', 'ciLowerLimit': '-119.61', 'ciUpperLimit': '-66.50', 'pValueComment': 'A significance level of a two-sided 5% was used for statistical hypothesis testing.', 'groupDescription': 'The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment', 'unitOfMeasure': 'mg/dL *h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Postprandial Glucose AUC After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '608.66', 'spread': '11.18', 'groupId': 'OG000'}, {'value': '683.17', 'spread': '14.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-74.51', 'ciLowerLimit': '-105.75', 'ciUpperLimit': '-43.27', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment', 'unitOfMeasure': 'mg/dL *h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '155.98', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '173.61', 'spread': '3.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-17.63', 'ciLowerLimit': '-25.00', 'ciUpperLimit': '-10.27', 'pValueComment': 'A significance level of a two-sided 5% was used for statistical hypothesis testing.', 'groupDescription': 'The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '167.39', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '184.60', 'spread': '4.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-17.21', 'ciLowerLimit': '-26.32', 'ciUpperLimit': '-8.09', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '59.69', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '79.66', 'spread': '3.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-19.97', 'ciLowerLimit': '-27.99', 'ciUpperLimit': '-11.94', 'pValueComment': 'A significance level of a two-sided 5% was used for statistical hypothesis testing.', 'groupDescription': 'The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '63.56', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '76.59', 'spread': '3.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-13.03', 'ciLowerLimit': '-21.46', 'ciUpperLimit': '-4.60', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Body Weight After 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '64.06', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '65.97', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-1.91', 'ciLowerLimit': '-2.34', 'ciUpperLimit': '-1.48', 'pValueComment': 'A significance level of a two-sided 5% was used for statistical hypothesis testing.', 'groupDescription': 'The analysis was performed based on an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate. The following null hypothesis (H0) was statistically tested against the alternative hypothesis (H1). H0: μ0.9 = μG, H1: μ0.9 ≠ μG where μ0.9 and μG are population mean after 24-week treatment for liraglutide 0.9 mg/day and glibenclamide, respectively.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 24 weeks of treatment', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Body Weight After 52 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '64.30', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '66.01', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean', 'ciPctValue': '95', 'paramValue': '-1.71', 'ciLowerLimit': '-2.25', 'ciUpperLimit': '-1.18', 'groupDescription': '95% confidence interval for the mean difference (liraglutide - glibenclamide) was calculated under an ANOVA model with treatment group and pre-trial treatment as fixed effects and corresponding baseline value as a covariate, and no statistical testing was performed.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'after 52 weeks of treatment', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) using LOCF (Last Observation Carried Forward) is all subjects who received at least one dose of study drug and have valid measurements both at baseline and at least one time point after baseline.'}, {'type': 'SECONDARY', 'title': 'Hypoglycaemic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'OG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'classes': [{'title': 'All hypoglycaemic episodes', 'categories': [{'measurements': [{'value': '0.694', 'groupId': 'OG000'}, {'value': '3.843', 'groupId': 'OG001'}]}]}, {'title': 'Major', 'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000'}, {'value': '0.000', 'groupId': 'OG001'}]}]}, {'title': 'Minor', 'categories': [{'measurements': [{'value': '0.187', 'groupId': 'OG000'}, {'value': '1.103', 'groupId': 'OG001'}]}]}, {'title': 'Symptoms only', 'categories': [{'measurements': [{'value': '0.507', 'groupId': 'OG000'}, {'value': '2.740', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.35', 'groupDescription': "The relative risk for 'All hypoglycaemic episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.", 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.09', 'ciUpperLimit': '0.36', 'groupDescription': "The relative risk for 'Minor episodes' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.", 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciPctValue': '95', 'paramValue': '0.20', 'ciLowerLimit': '0.11', 'ciUpperLimit': '0.34', 'groupDescription': "The relative risk for 'Symptoms only' and 95% confidence interval are based on a generalised linear negative-binomial model, which included treatment group as a fixed effect and log of exposure time as an offset variable.", 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'over 52 weeks of treatment', 'description': 'Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.', 'unitOfMeasure': 'number of events per year of exposure', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) consists of all subjects who received at least one dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'FG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '268'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '225'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Hypoglycaemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Missed measurement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Move', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '75 sites in Japan.', 'preAssignmentDetails': 'Subjects included in the study were patients with type 2 diabetes treated with diet therapy only or diet therapy and one OAD (Oral Anti-Diabetic Drug). Subjects on OAD therapy discontinued their current treatment during the run-in period (Weeks 4-6 before dosing). A total of 411 subjects were randomised, 11 subjects were not exposed to study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo'}, {'id': 'BG001', 'title': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': '70- years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.2', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '58.5', 'spread': '10.4', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '24.90', 'spread': '3.69', 'groupId': 'BG000'}, {'value': '24.62', 'spread': '3.84', 'groupId': 'BG001'}, {'value': '24.81', 'spread': '3.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '66.19', 'spread': '12.61', 'groupId': 'BG000'}, {'value': '65.43', 'spread': '12.89', 'groupId': 'BG001'}, {'value': '65.94', 'spread': '12.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of diabetes', 'classes': [{'categories': [{'measurements': [{'value': '8.13', 'spread': '6.68', 'groupId': 'BG000'}, {'value': '8.48', 'spread': '6.84', 'groupId': 'BG001'}, {'value': '8.25', 'spread': '6.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years since diagnosis of diabetes', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HbA1c', 'classes': [{'categories': [{'measurements': [{'value': '8.27', 'spread': '0.75', 'groupId': 'BG000'}, {'value': '8.28', 'spread': '0.78', 'groupId': 'BG001'}, {'value': '8.28', 'spread': '0.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Glycosylated Haemoglobin', 'unitOfMeasure': 'percentage of total haemoglobin', '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': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2009-10-26', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2006-10-27', 'dispFirstSubmitQcDate': '2009-10-26', 'resultsFirstSubmitDate': '2010-02-23', 'studyFirstSubmitQcDate': '2006-10-27', 'dispFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-02-23', 'studyFirstPostDateStruct': {'date': '2006-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c) After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Glycosylated Haemoglobin A1c (HbA1c) After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment'}, {'measure': 'Fasting Plasma Glucose After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment'}, {'measure': 'Fasting Plasma Glucose After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment'}, {'measure': 'Postprandial Glucose AUC After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Postprandial glucose AUC measured 0-3 hours after a meal after 24 weeks of treatment'}, {'measure': 'Postprandial Glucose AUC After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Postprandial glucose AUC measured 0-3 hours after a meal after 52 weeks of treatment'}, {'measure': 'Mean PG in 7-point Plasma Glucose Profile After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Plasma glucose (PG) profile measured after 24 weeks of treatment. The time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.'}, {'measure': 'Mean PG in 7-point Plasma Glucose Profile After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Mean plasma glucose(PG) in 7-point plasma glucose profile measured after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.'}, {'measure': 'Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment', 'description': 'Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 24 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.'}, {'measure': 'Mean Postprandial PG Increment in 7-point Plasma Glucose Profile After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment', 'description': 'Mean postprandial plasma glucose (PG) increment in 7-point plasma glucose profile, ie the mean of the difference of plasma glucose measured before and after a meal, after 52 weeks of treatment. The 7 time points during the day were: Before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, and at bedtime.'}, {'measure': 'Body Weight After 24 Weeks of Treatment', 'timeFrame': 'after 24 weeks of treatment'}, {'measure': 'Body Weight After 52 Weeks of Treatment', 'timeFrame': 'after 52 weeks of treatment'}, {'measure': 'Hypoglycaemic Episodes', 'timeFrame': 'over 52 weeks of treatment', 'description': 'Hypoglycaemic episodes measured over 52 weeks of treatment. Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20199137', 'type': 'RESULT', 'citation': 'Seino Y, Rasmussen MF, Nishida T, Kaku K. Efficacy and safety of the once-daily human GLP-1 analogue, liraglutide, vs glibenclamide monotherapy in Japanese patients with type 2 diabetes. Curr Med Res Opin. 2010 May;26(5):1013-22. doi: 10.1185/03007991003672551.'}, {'pmid': '24843595', 'type': 'RESULT', 'citation': 'Seino Y, Rasmussen MF, Clauson P, Kaku K. The once-daily human glucagon-like peptide-1 analog, liraglutide, improves beta-cell function in Japanese patients with type 2 diabetes. J Diabetes Investig. 2012 Aug 20;3(4):388-95. doi: 10.1111/j.2040-1124.2012.00193.x.'}, {'pmid': '23010561', 'type': 'RESULT', 'citation': 'Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.'}, {'pmid': '21209033', 'type': 'DERIVED', 'citation': 'Hegedus L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic control of liraglutide, compared to sulfonylurea (SU treatment), as assessed by HbA1c after 24 and 52 weeks in subjects with type 2 diabetes. Trial has a randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* Diet/exercise therapy with or without an oral anti-diabetic drug for at least eight weeks\n* HbA1c greater than or equal to 7.0% and less than 10.0%\n* BMI (Body Mass Index) less than 35 kg/m2\n\nExclusion Criteria:\n\n* Treatment with insulin within the last 12 weeks\n* Treatment with any drug that could interfere with the glucose level\n* Any serious medical condition\n* Females who are pregnant, have intention of becoming pregnant or are breastfeeding'}, 'identificationModule': {'nctId': 'NCT00393718', 'briefTitle': 'Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NN2211-1700'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liraglutide', 'description': 'Liraglutide 0.9 mg + glibenclamide placebo', 'interventionNames': ['Drug: liraglutide', 'Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glibenclamide', 'description': 'Glibenclamide 1.25-2.5 mg + liraglutide placebo', 'interventionNames': ['Drug: glibenclamide', 'Drug: placebo']}], 'interventions': [{'name': 'liraglutide', 'type': 'DRUG', 'description': '0.9 mg/day. Injected s.c. (under the skin) once daily.', 'armGroupLabels': ['Liraglutide']}, {'name': 'glibenclamide', 'type': 'DRUG', 'description': '1.25-2.5 mg tablet. Given orally once or twice daily.', 'armGroupLabels': ['Glibenclamide']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'liraglutide placebo. Injected s.c. (under the skin) once daily.', 'armGroupLabels': ['Glibenclamide']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'glibenclamide placebo. Given orally once or twice daily.', 'armGroupLabels': ['Liraglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000005', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], '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'}}}}