Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-21 @ 1:33 AM
Study NCT ID:
NCT02226003
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2014-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Bulgaria', 'Czechia', 'Estonia', 'Hungary', 'Israel', 'Ukraine', 'United Kingdom', '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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'C057619', 'term': 'glimepiride'}], 'ancestors': [{'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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 28', 'description': 'The serious adverse event table includes events after the initiation of glycemic rescue. The non-serious adverse event table excludes events after the initiation of glycemic rescue.', 'eventGroups': [{'id': 'EG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.', 'otherNumAtRisk': 98, 'otherNumAffected': 8, 'seriousNumAtRisk': 98, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.', 'otherNumAtRisk': 96, 'otherNumAffected': 3, 'seriousNumAtRisk': 96, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.', 'otherNumAtRisk': 97, 'otherNumAffected': 12, 'seriousNumAtRisk': 97, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.60', 'groupId': 'OG000', 'lowerLimit': '-1.82', 'upperLimit': '-1.39'}, {'value': '-1.68', 'groupId': 'OG001', 'lowerLimit': '-1.90', 'upperLimit': '-1.46'}, {'value': '-0.44', 'groupId': 'OG002', 'lowerLimit': '-0.69', 'upperLimit': '-0.19'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.49', 'ciUpperLimit': '-0.84', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.24', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '-0.91', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 HbA1C endpoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}, {'value': '42.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentage vs Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '16.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage vs Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-11.4', 'ciUpperLimit': '16.4', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 28', 'description': 'An adverse event (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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one dose of a study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '2.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 26', '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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ASaT population consisted of all randomized participants who received at least one dose of a study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48.25', 'groupId': 'OG000', 'lowerLimit': '-56.12', 'upperLimit': '-40.38'}, {'value': '-55.36', 'groupId': 'OG001', 'lowerLimit': '-63.29', 'upperLimit': '-47.42'}, {'value': '-9.30', 'groupId': 'OG002', 'lowerLimit': '-18.58', 'upperLimit': '-0.02'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-38.94', 'ciLowerLimit': '-49.93', 'ciUpperLimit': '-27.96', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.05', 'ciLowerLimit': '-57.09', 'ciUpperLimit': '-35.02', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'milligrams/deciliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 FPG endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-82.80', 'groupId': 'OG000', 'lowerLimit': '-95.96', 'upperLimit': '-69.64'}, {'value': '-90.03', 'groupId': 'OG001', 'lowerLimit': '-103.34', 'upperLimit': '-76.71'}, {'value': '-20.38', 'groupId': 'OG002', 'lowerLimit': '-35.62', 'upperLimit': '-5.14'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-62.42', 'ciLowerLimit': '-80.47', 'ciUpperLimit': '-44.37', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-69.65', 'ciLowerLimit': '-87.83', 'ciUpperLimit': '-51.46', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'milligrams/deciliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 2-hour PMG endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}, {'value': '8.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.88', 'ciLowerLimit': '2.81', 'ciUpperLimit': '16.83', 'statisticalMethod': 'Logistic regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.39', 'ciLowerLimit': '2.98', 'ciUpperLimit': '18.31', 'statisticalMethod': 'Logistic regression model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population includes randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline in the Week 26 HbA1C endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.94', 'groupId': 'OG000', 'lowerLimit': '-3.60', 'upperLimit': '-2.28'}, {'value': '-3.04', 'groupId': 'OG001', 'lowerLimit': '-3.71', 'upperLimit': '-2.38'}, {'value': '-0.94', 'groupId': 'OG002', 'lowerLimit': '-1.70', 'upperLimit': '-0.18'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.00', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '-1.01', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '-1.11', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'Kilograms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population is all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 body weight endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.04', 'groupId': 'OG000', 'lowerLimit': '-4.23', 'upperLimit': '0.16'}, {'value': '-3.98', 'groupId': 'OG001', 'lowerLimit': '-6.19', 'upperLimit': '-1.78'}, {'value': '2.41', 'groupId': 'OG002', 'lowerLimit': '-0.34', 'upperLimit': '5.15'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.44', 'ciLowerLimit': '-7.87', 'ciUpperLimit': '-1.01', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.39', 'ciLowerLimit': '-9.83', 'ciUpperLimit': '-2.95', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting systolic blood pressure endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'groupId': 'OG000', 'lowerLimit': '-1.99', 'upperLimit': '1.11'}, {'value': '-0.97', 'groupId': 'OG001', 'lowerLimit': '-2.52', 'upperLimit': '0.59'}, {'value': '1.21', 'groupId': 'OG002', 'lowerLimit': '-0.73', 'upperLimit': '3.15'}]}]}], 'analyses': [{'pValue': '0.184', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.65', 'ciLowerLimit': '-4.09', 'ciUpperLimit': '0.79', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.080', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in the Least Squares Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.18', 'ciLowerLimit': '-4.62', 'ciUpperLimit': '0.26', 'statisticalMethod': 'Constrained Longitudinal Data Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS population included all randomized participants who took at least 1 dose of study medication and had at least one assessment at or after baseline for the change from baseline in the Week 26 sitting diastolic blood pressure endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'FG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '91'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': "A total of 96 sites received independent ethics committees/institutional review boards' approval and 66 sites in 9 countries enrolled at least 1 participant.", 'preAssignmentDetails': 'The study included a 1-week screening period; an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period; and a 2-week single-blind placebo run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ertugliflozin 5 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.'}, {'id': 'BG001', 'title': 'Ertugliflozin 15 mg + Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.4', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '56.1', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '54.3', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '10.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2014-08-25', 'resultsFirstSubmitDate': '2017-02-23', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-23', 'studyFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1C (HbA1C) at Week 26 - Full Analysis Set (FAS Population Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1C represents the percentage of glycated hemoglobin. A negative number indicates a reduction in HbA1C level. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants as Treated Excluding Rescue Approach', 'timeFrame': 'Up to Week 28', 'description': 'An adverse event (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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Percentage of Participants Who Discontinued Study Medication Due to an AE - All Participants as Treated Excluding Rescue Approach', 'timeFrame': 'Up to Week 26', '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. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 - Full Analysis Set Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood glucose was measured after a ≥10 hour fast. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at baseline). Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 26 - Full Analysis Set Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'Change from baseline at Week 26 is defined as 2-hour PMG at Week 26 minus 2-hour PMG at Week 0. Two-hour post-meal glucose was measured following a standard meal. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Percentage of Participants With HbA1C <7% (<53 mmol/Mol) at Week 26', 'timeFrame': 'Week 26', 'description': 'HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). HbA1c represents the percentage of glycated hemoglobin.'}, {'measure': 'Change From Baseline in Body Weight at Week 26 - Full Analysis Set Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'Body weight was measured using a standardized, digital scale at each of the pre-defined nominal time points. Weight was taken in duplicate throughout the trial at approximately the same time of day, after voiding (i.e., forced void) and while wearing only a gown and underwear. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Change From Baseline in Sitting Systolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}, {'measure': 'Change From Baseline in Sitting Diastolic Blood Pressure at Week 26 - Full Analysis Set Excluding Rescue Approach', 'timeFrame': 'Baseline and Week 26', 'description': 'Blood pressure measurements were taken after at least 5 minutes of rest. Three measurements were taken approximately 2 minutes apart with the triplicate set recorded. Excluding rescue approach excludes all data following the initiation of rescue, in order to avoid the confounding influence of the rescue therapy with open-label glimepiride.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29313282', 'type': 'RESULT', 'citation': 'Miller S, Krumins T, Zhou H, Huyck S, Johnson J, Golm G, Terra SG, Mancuso JP, Engel SS, Lauring B. Ertugliflozin and Sitagliptin Co-initiation in Patients with Type 2 Diabetes: The VERTIS SITA Randomized Study. Diabetes Ther. 2018 Feb;9(1):253-268. doi: 10.1007/s13300-017-0358-0. Epub 2018 Jan 8.'}, {'pmid': '32700393', 'type': 'DERIVED', 'citation': 'Gallo S, Raji A, Calle RA, Pong A, Meyer C. The effects of ertugliflozin on beta-cell function: Pooled analysis from four phase 3 randomized controlled studies. Diabetes Obes Metab. 2020 Dec;22(12):2267-2275. doi: 10.1111/dom.14149. Epub 2020 Aug 27.'}, {'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': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the efficacy and safety of ertugliflozin (MK-8835/PF-04971729) in combination with sitagliptin in the treatment of participants with Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise. The primary hypothesis of the study is that ertugliflozin plus sitagliptin is more effective in lowering of hemoglobin A1C (HbA1C) than placebo.', 'detailedDescription': 'Each participant will be in the study for approximately 39 weeks including: a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (AHA) wash-off period, a 2-week single-blind placebo run-in period, a 26-week double-blind 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* Type 2 diabetes mellitus as per American Diabetes Association guidelines\n* Not on antihyperglycemic agent (AHA) \\>=8 weeks with a Visit 1/Screening HbA1C \\>=8.0% and \\<=10.5% (\\>=64 mmol/mol and \\<=91 mmol/mol) OR on single allowable AHA (allowable AHAs prior to screening are: metformin, α-glucosidase inhibitors, sulfonylureas and glinides) with a Visit 1/Screening HbA1C \\>=7.5% and \\<=10.0% (\\>=58 mmol/mol and \\<=86 mmol/mol) OR on low-dose dual combination therapy (≤50% of maximum labeled dose of an AHA) with allowable AHAs with a Visit 1/Screening HbA1C \\>=7.5% and \\<=10.0% (\\>=58 mmol/mol and \\<=86 mmol/mol)\n* Body mass index (BMI) \\>=18.0 kg/m\\^2\n* Male or female not of reproductive potential\n* Female of reproductive potential who agrees to (or have their partner agree to) remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception.\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus or diabetic ketoacidosis\n* History of other specific types of diabetes (e.g., 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 (SGLT2) inhibitor or sitagliptin\n* Has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: insulin of any type (except for short-term use \\[i.e., \\<=7 days\\] during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), pioglitazone or rosiglitazone, other sodium glucose co-transporter 2 (SGLT2) inhibitors, dipeptidyl-peptidase 4 inhibitors (DPP-4 inhibitors), bromocriptine (Cycloset™), colesevelam (Welchol™), any other AHA with the exception of the protocol-approved agents\n* Is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start\n* Has undergone bariatric surgery within the past 12 months or \\>12 months and is not weight stable prior to study start\n* A 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 start\n* Active, obstructive uropathy or indwelling urinary catheter\n* History of malignancy \\<=5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n* A known history of human immunodeficiency virus (HIV)\n* A blood dyscrasia or any disorder causing hemolysis or unstable red blood cells, or a clinically important hematological disorder (e.g. aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)\n* A medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease\n* Any clinically significant malabsorption condition\n* Current treatment for hyperthyroidism\n* On thyroid replacement therapy and not on a stable dose for at least 6 weeks prior study start\n* On a previous clinical study with ertugliflozin\n* Participated in other studies involving investigational drug(s) 30 days prior to study start\n* Surgical procedure within 6 weeks prior to study start or major surgery planned during the trial\n* Positive urine pregnancy test\n* Pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication\n* Planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication\n* Routinely consumes \\>2 alcoholic drinks per day or \\>14 alcoholic drinks per week or engages in binge drinking\n* Donated blood or blood products within 6 weeks of study start.'}, 'identificationModule': {'nctId': 'NCT02226003', 'briefTitle': 'Efficacy and Safety of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Diet and Exercise (MK-8835-017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Initial Combination of Ertugliflozin (MK-8835/PF-04971729) With Sitagliptin in the Treatment of Subjects With T2DM With Inadequate Glycemic Control on Diet and Exercise', 'orgStudyIdInfo': {'id': '8835-017'}, 'secondaryIdInfos': [{'id': '2014-001049-25', 'type': 'EUDRACT_NUMBER'}, {'id': 'B1521047', 'type': 'OTHER', 'domain': 'Pfizer Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 5 mg and Sitagliptin 100 mg', 'description': 'Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.', 'interventionNames': ['Drug: Ertugliflozin', 'Drug: Sitagliptin', 'Drug: Placebo to Ertugliflozin', 'Drug: Glimepiride']}, {'type': 'EXPERIMENTAL', 'label': 'Ertugliflozin 15 mg and Sitagliptin 100 mg', 'description': 'Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.', 'interventionNames': ['Drug: Ertugliflozin', 'Drug: Sitagliptin', 'Drug: Glimepiride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to Ertugliflozin and Placebo to Sitagliptin', 'description': 'Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.', 'interventionNames': ['Drug: Placebo to Ertugliflozin', 'Drug: Placebo to Sitagliptin', 'Drug: Glimepiride']}], 'interventions': [{'name': 'Ertugliflozin', 'type': 'DRUG', 'description': 'Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.', 'armGroupLabels': ['Ertugliflozin 15 mg and Sitagliptin 100 mg', 'Ertugliflozin 5 mg and Sitagliptin 100 mg']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.', 'armGroupLabels': ['Ertugliflozin 15 mg and Sitagliptin 100 mg', 'Ertugliflozin 5 mg and Sitagliptin 100 mg']}, {'name': 'Placebo to Ertugliflozin', 'type': 'DRUG', 'description': 'Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.', 'armGroupLabels': ['Ertugliflozin 5 mg and Sitagliptin 100 mg', 'Placebo to Ertugliflozin and Placebo to Sitagliptin']}, {'name': 'Placebo to Sitagliptin', 'type': 'DRUG', 'description': 'Matching placebo to sitagliptin administered orally, once daily for 26 weeks.', 'armGroupLabels': ['Placebo to Ertugliflozin and Placebo to Sitagliptin']}, {'name': 'Glimepiride', 'type': 'DRUG', 'description': 'Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.', 'armGroupLabels': ['Ertugliflozin 15 mg and Sitagliptin 100 mg', 'Ertugliflozin 5 mg and Sitagliptin 100 mg', 'Placebo to Ertugliflozin and Placebo to Sitagliptin']}]}, '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'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}