Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-01-24 @ 8:54 AM
Study NCT ID:
NCT01999218
Status:
COMPLETED
Last Update Posted:
2019-04-02
First Post:
2013-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Canada', 'Czechia', 'Hungary', 'Lithuania', 'Mexico', 'Philippines', 'Poland', 'Romania', 'Russia', 'Slovakia', 'South Africa', 'South Korea', 'Taiwan', 'United States']}, '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': 'C570288', 'term': 'ertugliflozin'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], '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'}]}}, '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 sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 106', 'description': 'The safety analysis population included all randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104', 'otherNumAtRisk': 445, 'deathsNumAtRisk': 445, 'otherNumAffected': 110, 'seriousNumAtRisk': 445, 'deathsNumAffected': 7, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104', 'otherNumAtRisk': 435, 'deathsNumAtRisk': 435, 'otherNumAffected': 104, 'seriousNumAtRisk': 435, 'deathsNumAffected': 2, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104', 'otherNumAtRisk': 435, 'deathsNumAtRisk': 435, 'otherNumAffected': 165, 'seriousNumAtRisk': 435, 'deathsNumAffected': 1, 'seriousNumAffected': 30}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 31, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 39, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 27, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 33, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asymptomatic hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 87, 'numAffected': 27}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 53, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 470, 'numAffected': 82}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Nervous 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Single vessel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Triple vessel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cataract aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chorioretinal folds', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Senile cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Multiple cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression worsened', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Recurrent depressive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic retention of urine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Kidney stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Balanoposthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Choanal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive airways disease exacerbated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Obstructive chronic bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vocal cord nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Foot ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetic peripheral angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Leg ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 435, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 435, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.56', 'groupId': 'OG000', 'lowerLimit': '-0.65', 'upperLimit': '-0.47'}, {'value': '-0.64', 'groupId': 'OG001', 'lowerLimit': '-0.73', 'upperLimit': '-0.55'}, {'value': '-0.74', 'groupId': 'OG002', 'lowerLimit': '-0.83', 'upperLimit': '-0.65'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.22', 'estimateComment': 'Constrained Longitudinal Data Analysis (cLDA) model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.30', 'estimateComment': 'Based on cLDA model with fixed effects for treatment, time, prior antihyperglycemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.\n\nTime was treated as a categorical variable.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority is declared if the upper bound of the two-sided 95% confidence interval (CI) for the mean difference is less than 0.3%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, treated participants with at least one A1C measurement (baseline or a post-baseline).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}, {'value': '435', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}, {'value': '71.3', 'groupId': 'OG001'}, {'value': '69.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '7.7', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on Miettinen \\& Nurminen method'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '6.5', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Based on Miettinen \\& Nurminen method'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 106', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}, {'value': '435', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '8.0', 'groupId': 'OG001'}, {'value': '5.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '6.4', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '4.7', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 104', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of trial treatment, 10 randomized participants from one trial site were excluded from these analyzes, and one randomized participant did not receive treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}, {'value': '19.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.0', 'ciLowerLimit': '-18.4', 'ciUpperLimit': '-9.8', 'statisticalMethod': 'Based on Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Based on Miettinen \\& Nurminen method'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in % vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.1', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '-12.2', 'statisticalMethod': 'Based on Miettinen & Nurminen method', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Based on Miettinen \\& Nurminen method'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who took at least one dose of trial treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.96', 'groupId': 'OG000', 'lowerLimit': '-3.31', 'upperLimit': '-2.61'}, {'value': '-3.38', 'groupId': 'OG001', 'lowerLimit': '-3.73', 'upperLimit': '-3.03'}, {'value': '0.91', 'groupId': 'OG002', 'lowerLimit': '0.56', 'upperLimit': '1.25'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LSM vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.29', 'ciLowerLimit': '-4.77', 'ciUpperLimit': '-3.80', 'estimateComment': 'LSM=Least Squares Means', 'statisticalMethod': 'Constrained Longitudinal Data analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Constrained Longitudinal Data analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the LSM vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.87', 'ciLowerLimit': '-4.36', 'ciUpperLimit': '-3.38', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Constrained Longitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior antihyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.', 'unitOfMeasure': 'Kilograms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, treated participants with at least one body weight measurement (baseline or a post-baseline).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}, {'value': '437', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'OG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.25', 'groupId': 'OG000', 'lowerLimit': '-3.36', 'upperLimit': '-1.13'}, {'value': '-3.81', 'groupId': 'OG001', 'lowerLimit': '-4.91', 'upperLimit': '-2.71'}, {'value': '0.95', 'groupId': 'OG002', 'lowerLimit': '-0.15', 'upperLimit': '2.06'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the LSM vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.77', 'ciLowerLimit': '-6.29', 'ciUpperLimit': '-3.25', 'statisticalMethod': 'Constrained Logitudinal Data Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the LSM vs. Glimepiride', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.001', 'paramValue': '-3.20', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '-1.67', 'statisticalMethod': 'Constrained Logitudinal Data Analysis', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Constrained Logitudinal Data Analysis with fixed effects for treatment, time, interaction of time by treatment, prior anthyperglycemic medication (monotherapy or dual therapy), and baseline eGFR (continuous).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 52', 'description': 'This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized, treated participants with at least one SBP measurement (baseline or a post-baseline).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'FG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'FG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '441'}, {'groupId': 'FG002', 'numSubjects': '437'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '437'}]}, {'type': 'Site Issue', 'comment': 'Treated (excluding 1 trial site)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}, {'groupId': 'FG001', 'numSubjects': '435'}, {'groupId': 'FG002', 'numSubjects': '435'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '339'}, {'groupId': 'FG001', 'numSubjects': '340'}, {'groupId': 'FG002', 'numSubjects': '327'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '110'}]}], 'dropWithdraws': [{'type': 'Hyperglycemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Non-Compliance With Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Participant moves', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'Creatinine/eGFR', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Excluded Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Treated but excluded at 1 trial site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The trial was conducted in 16 countries at 232 trial centers in Argentina, Canada, Czech Republic, Hungary, South Korea, Lithuania, Mexico, Philippines, Poland, Romania, Russia, Slovakia, South Africa, Taiwan, Ukraine, and the United States.', 'preAssignmentDetails': 'A total of 1326 participants were randomized. Ten randomized participants from one trial site were excluded from all final analyses (Week 104 and beyond), and one randomized participant did not receive treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1326', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104'}, {'id': 'BG001', 'title': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104'}, {'id': 'BG002', 'title': 'Glimepiride', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1326', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '58.8', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '57.8', 'spread': '9.2', 'groupId': 'BG002'}, {'value': '58.2', 'spread': '9.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1326', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}, {'value': '684', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '642', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All randomized participants', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1326', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '316', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}, {'value': '966', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1325', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '87.9', 'spread': '18.9', 'groupId': 'BG000'}, {'value': '85.6', 'spread': '19.1', 'groupId': 'BG001'}, {'value': '86.8', 'spread': '20.7', 'groupId': 'BG002'}, {'value': '86.8', 'spread': '19.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants and treated participants.'}, {'title': 'Hemoglobin A1C', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1325', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.81', 'spread': '0.60', 'groupId': 'BG000'}, {'value': '7.80', 'spread': '0.60', 'groupId': 'BG001'}, {'value': '7.76', 'spread': '0.60', 'groupId': 'BG002'}, {'value': '7.79', 'spread': '0.60', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants with a baseline A1C measurement.'}, {'title': 'Sitting Systolic Blood Pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1325', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '130.2', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '130.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '129.9', 'spread': '12.0', 'groupId': 'BG002'}, {'value': '130.3', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized participants with baseline sitting systolic blood pressure data.'}, {'title': 'Prior Antihyperglycemic (AHA) Medication (Monotherapy or Dual Therapy)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1326', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Prior Antihyperglycemic Medication', 'measurements': [{'value': '448', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1324', 'groupId': 'BG003'}]}, {'title': 'No Prior Use & Not on Antihyperglycemic Medication', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Data not available', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'All randomized participants with information on or baseline data of prior antihyperglycemic medication use'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '440', 'groupId': 'BG001'}, {'value': '437', 'groupId': 'BG002'}, {'value': '1325', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '88.3', 'spread': '18.7', 'groupId': 'BG000'}, {'value': '86.7', 'spread': '18.3', 'groupId': 'BG001'}, {'value': '86.6', 'spread': '18.5', 'groupId': 'BG002'}, {'value': '87.2', 'spread': '18.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milliliters/minute/1.73 meters^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'All randomized and treated participants.'}], 'populationDescription': 'All randomized participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-26', 'size': 8033855, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-04-10T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1326}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2013-11-25', 'resultsFirstSubmitDate': '2018-04-10', 'studyFirstSubmitQcDate': '2013-11-25', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-04-10', 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1C (A1C) at Week 52: Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 52', 'description': 'A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The primary study objective was the MK-8835 15 mg vs. glimepiride comparison; the MK-8835 5mg vs glimerpiride comparison was a secondary study objective.'}, {'measure': 'Percentage of Participants Experiencing An Adverse Event (AE) Up to Week 106', 'timeFrame': 'Up to Week 106', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}, {'measure': 'Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 104', 'timeFrame': 'Up to Week 104', 'description': 'An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 52: Excluding Rescue Approach', 'timeFrame': 'Up to Week 52', 'description': 'Symptomatic hypoglycemia was an event with clinical symptoms reported by the investigator as hypoglycemia (biochemical documentation not required). Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.'}, {'measure': 'Change From Baseline in Body Weight at Week 52 Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 52', 'description': 'This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.'}, {'measure': 'Change From Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 52', 'description': 'This change from baseline reflects the Week 52 SBP minus the Week 0 SBP. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '30760125', 'type': 'RESULT', 'citation': 'Hollander P, Hill J, Johnson J, Wei Jiang Z, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B, Liu J. Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin. Curr Med Res Opin. 2019 Aug;35(8):1335-1343. doi: 10.1080/03007995.2019.1583450. Epub 2019 Mar 25.'}, {'pmid': '32648108', 'type': 'DERIVED', 'citation': 'Gallo S, Calle RA, Terra SG, Pong A, Tarasenko L, Raji A. Effects of Ertugliflozin on Liver Enzymes in Patients with Type 2 Diabetes: A Post-Hoc Pooled Analysis of Phase 3 Trials. Diabetes Ther. 2020 Aug;11(8):1849-1860. doi: 10.1007/s13300-020-00867-1. Epub 2020 Jul 9.'}, {'pmid': '32372382', 'type': 'DERIVED', 'citation': 'Patel S, Hickman A, Frederich R, Johnson S, Huyck S, Mancuso JP, Gantz I, Terra SG. Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Seven Phase 3 Randomized Controlled Trials. Diabetes Ther. 2020 Jun;11(6):1347-1367. doi: 10.1007/s13300-020-00803-3. Epub 2020 May 5.'}, {'pmid': '32324082', 'type': 'DERIVED', 'citation': 'Liu J, Tarasenko L, Pong A, Huyck S, Wu L, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Efficacy and safety of ertugliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Aug;36(8):1277-1284. doi: 10.1080/03007995.2020.1760228. Epub 2020 May 13.'}, {'pmid': '32324065', 'type': 'DERIVED', 'citation': 'Liu J, Tarasenko L, Pong A, Huyck S, Patel S, Hickman A, Mancuso JP, Ellison MC, Gantz I, Terra SG. Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus. Curr Med Res Opin. 2020 Jul;36(7):1097-1106. doi: 10.1080/03007995.2020.1760227. Epub 2020 May 13.'}, {'pmid': '32236732', 'type': 'DERIVED', 'citation': 'Cherney DZI, Heerspink HJL, Frederich R, Maldonado M, Liu J, Pong A, Xu ZJ, Patel S, Hickman A, Mancuso JP, Gantz I, Terra SG. Effects of ertugliflozin on renal function over 104 weeks of treatment: a post hoc analysis of two randomised controlled trials. Diabetologia. 2020 Jun;63(6):1128-1140. doi: 10.1007/s00125-020-05133-4. Epub 2020 Mar 31.'}, {'pmid': '31797522', 'type': 'DERIVED', 'citation': 'Liu J, Patel S, Cater NB, Wu L, Huyck S, Terra SG, Hickman A, Darekar A, Pong A, Gantz I. Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2020 Apr;22(4):574-582. doi: 10.1111/dom.13931. Epub 2020 Jan 3.'}, {'pmid': '29282633', 'type': 'DERIVED', 'citation': 'Hollander P, Liu J, Hill J, Johnson J, Jiang ZW, Golm G, Huyck S, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin Compared with Glimepiride in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin: The VERTIS SU Randomized Study. Diabetes Ther. 2018 Feb;9(1):193-207. doi: 10.1007/s13300-017-0354-4. Epub 2017 Dec 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of the addition of ertugliflozin (MK-8835/PF-04971729) compared with the addition of glimepiride in participants with T2DM who have inadequate glycemic control on metformin. The primary hypothesis of this study is that after 52 weeks, the change from baseline in hemoglobin A1c (A1C) in participants treated with the addition of ertugliflozin 15 mg once daily is non-inferior compared with that in participants treated with the addition of glimepiride.', 'detailedDescription': 'The duration of the trial will be up to approximately 122 weeks. This will include a 1-week screening period, an up to 13-week wash-off/titration/dose stabilization period, a 2-week placebo run-in period, a 104-week double-blind, active comparator-controlled treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of T2DM in accordance to American Diabetes Association guidelines\n* On metformin monotherapy or metformin in combination with a single allowable anti-hyperglycemic agent (AHA), DPP-4 inhibitors, meglitinides and AGIs are listed as allowable AHAs along with sulfonylureas prior to study participation.\n* Body Mass Index (BMI) ≥18.0 kg/m\\^2\n* Male or female not of reproductive potential\n* If a female of reproductive potential, agree to remain abstinent or to use (or have their partner use) 2 acceptable combinations of birth control while participating in the trial and for 14 days after the last use of study drug.\n\nExclusion Criteria:\n\n* History or presence of type 1 diabetes mellitus or a history of ketoacidosis\n* History of other specific types of diabetes (eg, genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant).\n* A known hypersensitivity or intolerance to any sodium-glucose co-transporter 2 (SGLT2) inhibitor\n* Use of the following prohibited therapeutic agents within 12 weeks of study participation: insulin, injectable anti-hyperglycemic agents, pioglitazone or rosiglitazone, another SGLT2 inhibitor, bromocriptine (Cycloset®), colesevelam (Welchol®), and any other non-approved anti-hyperglycemic therapy\n* Known hypersensitivity or intolerance to metformin or glimepiride\n* On a weight-loss program or medication or medication associated with weight changes and is not weight-stable (\\>=5% change in body weight in the last 6 months)\n* History of bariatric surgery less than 12 months prior to study participation\n* History of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or New York Heart Association (NYHA) functional class III-IV heart failure within 3 months of study participation\n* Active, obstructive uropathy or an indwelling urinary catheter\n* A history of malignancy ≤5 years prior to study participation, except for adequately treated basal or squamous cell skin cancer or in situ cervical cancer\n* Known history of Human Immunodeficiency Virus (HIV)\n* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells\n* A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or symptomatic gallbladder disease\n* Any clinically significant malabsorption condition\n* Being treated for hyperthyroidism, or on thyroid replacement therapy that has not been at a stable dose for at least 6 weeks prior to study participation\n* Previous randomization in a study with ertugliflozin\n* Participation in other studies involving investigational drug(s) within 30 days of study participation and/or during the pre-randomization period\n* A surgical procedure within 6 weeks prior to study participation or planned major surgery during the trial\n* A positive urine pregnancy test\n* Pregnant or breast-feeding, or expecting to conceive during the trial, including 14 days following the last dose of study drug\n* Undergoing hormonal therapy in preparation to donate eggs during the period of the trial, including 14 days following the last dose of study drug\n* Consumption of more than 2 alcoholic drinks per day or engages in binge drinking\n* Donation of blood or blood products within 6 weeks of study participation or plans to donate blood or blood products at any time during the trial'}, 'identificationModule': {'nctId': 'NCT01999218', 'briefTitle': 'Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Ertugliflozin (MK-8835/PF-04971729) Compared With the Addition of Glimepiride in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin', 'orgStudyIdInfo': {'id': '8835-002'}, 'secondaryIdInfos': [{'id': '2013-003582-34', 'type': 'EUDRACT_NUMBER'}, {'id': 'B1521013', 'type': 'OTHER', 'domain': 'Pfizer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 5 mg', 'description': 'Ertugliflozin 5 mg once daily (QD) from Day 1 to Week 104', 'interventionNames': ['Drug: Ertugliflozin 5 mg', 'Drug: Placebo to Ertugliflozin', 'Drug: Placebo to Glimepiride', 'Drug: Metformin', 'Drug: Sitagliptin']}, {'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 15 mg', 'description': 'Ertugliflozin 15 mg QD from Day 1 to Week 104', 'interventionNames': ['Drug: Ertugliflozin 5 mg', 'Drug: Ertugliflozin 10 mg', 'Drug: Placebo to Glimepiride', 'Drug: Metformin', 'Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glimepiride up to 8 mg', 'description': 'Glimepiride to a maximum of 8 mg QD from Day 1 to Week 104', 'interventionNames': ['Drug: Glimerpiride', 'Drug: Placebo to Ertugliflozin', 'Drug: Metformin', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Ertugliflozin 5 mg', 'type': 'DRUG', 'otherNames': ['MK-8835'], 'description': 'Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104', 'armGroupLabels': ['Ertugliflozin 15 mg', 'Ertugliflozin 5 mg']}, {'name': 'Ertugliflozin 10 mg', 'type': 'DRUG', 'otherNames': ['MK-8355'], 'description': 'Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.', 'armGroupLabels': ['Ertugliflozin 15 mg']}, {'name': 'Glimerpiride', 'type': 'DRUG', 'description': 'Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose', 'armGroupLabels': ['Glimepiride up to 8 mg']}, {'name': 'Placebo to Ertugliflozin', 'type': 'DRUG', 'description': 'Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104', 'armGroupLabels': ['Ertugliflozin 5 mg', 'Glimepiride up to 8 mg']}, {'name': 'Placebo to Glimepiride', 'type': 'DRUG', 'description': 'Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.', 'armGroupLabels': ['Ertugliflozin 15 mg', 'Ertugliflozin 5 mg']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Participants are to remain on their stable doses of metformin (oral, \\>=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin \\<1500 at screening are up-titrated to \\>= 1500 daily.', 'armGroupLabels': ['Ertugliflozin 15 mg', 'Ertugliflozin 5 mg', 'Glimepiride up to 8 mg']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Open label, oral, once daily, rescue medication as required.', 'armGroupLabels': ['Ertugliflozin 15 mg', 'Ertugliflozin 5 mg', 'Glimepiride up to 8 mg']}]}, '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': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}