Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT01709305
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2012-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D008687', 'term': 'Metformin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D020909', 'term': 'Acarbose'}, {'id': 'C072379', 'term': 'repaglinide'}, {'id': 'C057619', 'term': 'glimepiride'}, {'id': 'D005907', 'term': 'Gliclazide'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D014312', 'term': 'Trisaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 46 Weeks', 'description': 'All Participants as Treated (APaT) - all participants enrolled (Phase 1) or randomized (Phase 2) who received at least one dose of study treatment and complied with GCP requirements. Participants were included in the treatment group corresponding to the study treatment they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: Sitagliptin + Metformin', 'description': 'During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).', 'otherNumAtRisk': 5527, 'otherNumAffected': 66, 'seriousNumAtRisk': 5527, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'otherNumAtRisk': 551, 'otherNumAffected': 3, 'seriousNumAtRisk': 551, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'otherNumAtRisk': 545, 'otherNumAffected': 33, 'seriousNumAtRisk': 545, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'otherNumAtRisk': 550, 'otherNumAffected': 20, 'seriousNumAtRisk': 550, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'otherNumAtRisk': 549, 'otherNumAffected': 48, 'seriousNumAtRisk': 549, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 84, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 51, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 35, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 72, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Entropion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Optic Ischaemic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastric Polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrointestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic Hepatopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic Function Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Spermatic Cord Funiculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vestibular Neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meniscus Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Brain Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gallbladder Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ovarian Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thyroid Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Carotid Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lacunar Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myasthenia Gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vascular Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Calculus Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Drug Eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Incisional Drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Interventional Procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Essential Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Varicose Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Duodenal Ulcer Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vascular Stent Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Liver Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hand Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gouty Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Myelodysplastic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tongue Neoplasm Malignant Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diabetic Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vertebrobasilar Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nephrotic Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5527, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 545, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 550, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '414', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '472', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.84', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '-0.57'}, {'value': '-0.62', 'spread': '0.84', 'groupId': 'OG001', 'lowerLimit': '-0.69', 'upperLimit': '-0.54'}, {'value': '-0.46', 'spread': '0.83', 'groupId': 'OG002', 'lowerLimit': '-0.53', 'upperLimit': '-0.38'}, {'value': '-0.69', 'spread': '0.90', 'groupId': 'OG003', 'lowerLimit': '-0.77', 'upperLimit': '-0.61'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.34', 'paramValue': '0.19', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.36', 'groupDescription': 'Pairwise Comparison', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.34', 'paramValue': '0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.21', 'groupDescription': 'Pairwise Comparison', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.34', 'paramValue': '-0.05', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.14', 'groupDescription': 'Pairwise Comparison', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority criterion are met when the upper limit of the two-sided 98.34% CI for the difference in LS means is less than or equal to the pre-specified non-inferiority margin of 0.3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Phase 2 Baseline (Week 20) and Week 44', 'description': 'HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol (PP) population - excluded those participants who were identified as protocol violators and those who were non-compliant with Good Clinical Practice (GCP) requirements.'}, {'type': 'SECONDARY', 'title': 'Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}, {'value': '509', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '2.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2 Baseline (Week 20), Week 44', 'description': 'Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Hypoglycemia Events (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}, {'value': '550', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '6.1', 'groupId': 'OG001'}, {'value': '0.5', 'groupId': 'OG002'}, {'value': '3.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.4', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '-6.1', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-6.1', 'ciUpperLimit': '0.3', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '-2.5', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 20 through Week 44', 'description': 'Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}, {'value': '550', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.3', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.7', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.318', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.0', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "nausea" was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a GI AE of Vomiting (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}, {'value': '550', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.2', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.998', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.9', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.319', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.5', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.999', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.9', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "vomiting" was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a GI AE of Diarrhea (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}, {'value': '550', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.9', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.651', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.8', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.660', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.8', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.480', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.6', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "diarrhea" was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '545', 'groupId': 'OG001'}, {'value': '551', 'groupId': 'OG002'}, {'value': '550', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG001', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG002', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}, {'id': 'OG003', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '1.3', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.7', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.318', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Estimate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.0', 'groupDescription': 'Difference in % vs. Glimepiride', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "abdominal pain" was reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT) - all randomized participants who received at least one (1) dose of study treatment and were compliant with GCP requirements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1: Sitagliptin + Metformin', 'description': 'During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.'}, {'id': 'FG001', 'title': 'Phase 2: Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.'}, {'id': 'FG002', 'title': 'Phase 2: Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.'}, {'id': 'FG003', 'title': 'Phase 2: Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.'}, {'id': 'FG004', 'title': 'Phase 2: Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5570'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4933'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '637'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Clinical Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Hyperglycemia (lack of efficacy)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Laboratory Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Travel, moving, etc.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '218'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '552'}, {'groupId': 'FG002', 'numSubjects': '550'}, {'groupId': 'FG003', 'numSubjects': '556'}, {'groupId': 'FG004', 'numSubjects': '554'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '500'}, {'groupId': 'FG002', 'numSubjects': '505'}, {'groupId': 'FG003', 'numSubjects': '508'}, {'groupId': 'FG004', 'numSubjects': '507'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Clinical Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Hyperglycemia (lack of efficacy)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Laboratory Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Travel, moving, etc.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Adult Chinese participants (≥18 and ≤75 years of age) with a diagnosis of Type 2 Diabetes Mellitus (T2DM) and inadequate glycemic control were selected to participate in this study.', 'preAssignmentDetails': 'There were 2344 participants who achieved A1C\\<7% in Phase 1; they completed Phase 1 and did not enter Phase 2. Of the remaining 2589 participants, 377 participants did not meet randomization criteria to enter Phase 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5535', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.1', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2240', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3295', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This population includes all participants who enrolled in Phase 1 and were GCP compliant.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2015-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2012-10-16', 'resultsFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-04-06', 'studyFirstPostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Phase 2 Baseline to Week 44 in Hemoglobin A1c (HbA1c) Levels (Phase 2)', 'timeFrame': 'Phase 2 Baseline (Week 20) and Week 44', 'description': 'HbA1c is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change from baseline reflects the Week 44 A1C minus baseline A1C. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used. Change from baseline was based on the constrained longitudinal data analysis (cLDA) model including all available measurements from baseline through the last visit. The terms in the cLDA model include treatment, time in weeks (categorical), regions, and treatment-by-time interaction.'}], 'secondaryOutcomes': [{'measure': 'Change From Phase 2 Baseline to Week 44 in Participant Body Weight (Phase 2)', 'timeFrame': 'Phase 2 Baseline (Week 20), Week 44', 'description': 'Change from baseline in body weight in Phase 2 was reported. Change from baseline reflects the Week 44 body weight minus baseline body weight. Baseline is defined as Visit 6/Week 20. If this measurement was unavailable, the Week 16 value was used.'}, {'measure': 'Percentage of Participants With Hypoglycemia Events (Phase 2)', 'timeFrame': 'From Week 20 through Week 44', 'description': 'Hypoglycemia events represent epidsodes symptomatic of hypoglycemia (e.g., weakness, dizziness, shakiness, increased sweating, palpitations, or confusion) and/or finger stick glucose values of ≤70 mg/dL (3.9 mmol/L). The percentage of participants with hypoglycemia events was reported.'}, {'measure': 'Percentage of Participants With a Gastrointestinal (GI) AE of Nausea (Phase 2)', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "nausea" was reported.'}, {'measure': 'Percentage of Participants With a GI AE of Vomiting (Phase 2)', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "vomiting" was reported.'}, {'measure': 'Percentage of Participants With a GI AE of Diarrhea (Phase 2)', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "diarrhea" was reported.'}, {'measure': 'Percentage of Participants With a GI AE of Abdominal Pain (Phase 2)', 'timeFrame': 'From Week 20 through Week 44', 'description': 'The percentage of participants with a GI AE of "abdominal pain" was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '28271251', 'type': 'RESULT', 'citation': 'Xu W, Mu Y, Zhao J, Zhu D, Ji Q, Zhou Z, Yao B, Mao A, Engel SS, Zhao B, Bi Y, Zeng L, Ran X, Lu J, Ji L, Yang W, Jia W, Weng J. Efficacy and safety of metformin and sitagliptin based triple antihyperglycemic therapy (STRATEGY): a multicenter, randomized, controlled, non-inferiority clinical trial. Sci China Life Sci. 2017 Mar;60(3):225-238. doi: 10.1007/s11427-016-0409-7. Epub 2017 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of adding acarbose or repaglinide or gliclazide to sitagliptin plus metformin, compared to adding glimepiride, on glycemic improvements in Type 2 Diabetes Mellitus (T2DM) participants who require the addition of a third oral anti-hyperglycemic agent (OAHA) according to China Guideline for Type 2 Diabetes. The three co-primary hypotheses are that after 24 weeks of treatment in phase 2, the mean change from baseline in hemoglobin A1c (A1c) in participants receiving either (1)acarbose or (2)repaglinide or (3)gliclazide added to sitagliptin and metformin combination is non-inferior to that of participants receiving glimepiride added to sitagliptin and metformin combination. The study would be declared successful if at least one of the three primary hypotheses was met.', 'detailedDescription': 'Participants coming on study will be stabilized to a standardized metformin dose: this may take about 10 weeks, and then combination therapy with metformin + sitagliptin will begin during Phase 1 (Week 0 through Week 20). If a participant has already been on a stabilized metformin dose, they will start immediately on combination therapy with metformin + sitagliptin for 20 weeks (Phase 1).\n\nIn Phase 2, participants who have failed to achieve adequate glycemic control (A1c ≥ 7% and ≤ 10% at Week 16 and fasting finger stick glucose ≥130 mg/dL and ≤280 mg/dL at Week 20) will be randomized to receive add-on therapy with glimepiride, repaglinide, acarbose, or gliclazide for 24 weeks (Week 20 through Week 44).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has Type 2 Diabetes Mellitus;\n* Agrees to use an effective method of contraception or must not otherwise be at risk of becoming pregnant (female participants).\n\nExclusion Criteria:\n\n* Has a history of type 1 diabetes mellitus or a history of ketoacidosis;\n* Has been treated with insulin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, a Glucagon-like peptide-1 (GLP-1) mimetic or analogue before;\n* Is on a weight loss program (not in maintenance phase), has started a weight loss medication, or has undergone bariatric surgery within 12 months;\n* Has undergone a surgical procedure within 4 weeks;\n* Has had new or worsening signs or symptoms of coronary heart disease or congestive heart failure within past 3 months, or has acute coronary syndrome, coronary artery intervention, or stroke or transient ischemic neurological disorder;\n* Has a medical history of active liver disease, including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease;\n* Has poorly controlled hypertension;\n* Has severe peripheral vascular disease;\n* Has human immunodeficiency virus (HIV);\n* Has had a clinically important hematological disorder;\n* Routinely consumes \\>2 alcoholic drinks per day or \\>14 alcoholic drinks per week, or engages in binge drinking;\n* Has a history of intolerance or hypersensitivity or any contraindication to study medications (including sitagliptin, metformin, glimepiride, repaglinide, acarbose or gliclazide) based upon the Chinese label;\n* Is on or likely to require treatment with ≥2 consecutive weeks or repeated courses of pharmacologic doses of corticosteroids (other than inhaled, nasal, or topical corticosteroids);\n* Is pregnant or breast feeding or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug (female participants).'}, 'identificationModule': {'nctId': 'NCT01709305', 'briefTitle': 'A Study of the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose When Added to Sitagliptin + Metformin Combination Therapy in Chinese Participants With Diabetes (MK-0431-313)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Active-Controlled, Open-label Clinical Trial to Evaluate the Safety and Efficacy of Glimepiride, Gliclazide, Repaglinide or Acarbose as a Third OAHA on Top of Sitagliptin+Metformin Combination Therapy in Chinese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0431-313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin + Sitagliptin + Glimepiride', 'description': 'During Phase 2, participants receive up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'interventionNames': ['Drug: Metformin', 'Drug: Sitagliptin', 'Drug: Glimepiride']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin + Sitagliptin + Repaglinide', 'description': 'During Phase 2, participants receive up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'interventionNames': ['Drug: Metformin', 'Drug: Sitagliptin', 'Drug: Repaglinide']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin + Sitagliptin + Acarbose', 'description': 'During Phase 2, participants receive 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'interventionNames': ['Drug: Metformin', 'Drug: Sitagliptin', 'Drug: Acarbose']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin + Sitagliptin + Gliclazide', 'description': 'During Phase 2, participants receive 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).', 'interventionNames': ['Drug: Metformin', 'Drug: Sitagliptin', 'Drug: Gliclazide']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Fortamet®', 'Glucophage®', 'Glucophage® XR', 'Glumetza®', 'Riomet®', 'Metgluco®', 'Glycoran®'], 'description': 'Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.', 'armGroupLabels': ['Metformin + Sitagliptin + Acarbose', 'Metformin + Sitagliptin + Gliclazide', 'Metformin + Sitagliptin + Glimepiride', 'Metformin + Sitagliptin + Repaglinide']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia®', 'Tesavel®', 'Xelevia®', 'Ristaben®'], 'description': 'Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food', 'armGroupLabels': ['Metformin + Sitagliptin + Acarbose', 'Metformin + Sitagliptin + Gliclazide', 'Metformin + Sitagliptin + Glimepiride', 'Metformin + Sitagliptin + Repaglinide']}, {'name': 'Acarbose', 'type': 'DRUG', 'otherNames': ['Precose®', 'Glucobay™'], 'description': 'Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.', 'armGroupLabels': ['Metformin + Sitagliptin + Acarbose']}, {'name': 'Repaglinide', 'type': 'DRUG', 'otherNames': ['Prandin®', 'Fulaidi™'], 'description': 'Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.', 'armGroupLabels': ['Metformin + Sitagliptin + Repaglinide']}, {'name': 'Glimepiride', 'type': 'DRUG', 'otherNames': ['Amaryl®', 'Glimy'], 'description': 'Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day', 'armGroupLabels': ['Metformin + Sitagliptin + Glimepiride']}, {'name': 'Gliclazide', 'type': 'DRUG', 'otherNames': ['Diamicron MR™'], 'description': 'Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.', 'armGroupLabels': ['Metformin + Sitagliptin + Gliclazide']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}