Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT01462266
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2011-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)
Sponsor:
Organization:
Raw JSON
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Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 24 + 14-day follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.', 'otherNumAtRisk': 329, 'otherNumAffected': 121, 'seriousNumAtRisk': 329, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.', 'otherNumAtRisk': 329, 'otherNumAffected': 168, 'seriousNumAtRisk': 329, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 358, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 794, 'numAffected': 144}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Monarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Spermatocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ingrowing nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 329, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 329, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Daily Insulin Dose at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '19.6', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '21.6'}, {'value': '23.8', 'spread': '24.0', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '26.3'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '-1.2', 'statisticalMethod': 'Longitudinal data analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Adjusting for participant's use of metformin at Visit 1/Screening Visit (i.e., on metformin, or not on metformin)"}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)', 'unitOfMeasure': 'International Units (IU)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.31', 'spread': '0.98', 'groupId': 'OG000', 'lowerLimit': '-1.43', 'upperLimit': '-1.20'}, {'value': '-0.87', 'spread': '1.10', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '-0.75'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)', 'unitOfMeasure': 'Percent of total hemoglobin', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-55.5', 'spread': '52.0', 'groupId': 'OG000', 'lowerLimit': '-61.1', 'upperLimit': '-49.9'}, {'value': '-44.8', 'spread': '62.4', 'groupId': 'OG001', 'lowerLimit': '-50.4', 'upperLimit': '-39.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '82.2'}, {'value': '74.1', 'groupId': 'OG001', 'lowerLimit': '69.0', 'upperLimit': '79.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who took at least one dose of study medication, and had at least one post-randomization glycemic goal assessment.'}, {'type': 'SECONDARY', 'title': 'Time to Achieve the Fasting Glucose Target', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '85'}, {'value': '90', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '107'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 24 weeks', 'description': 'Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.', 'unitOfMeasure': 'Days to first attainment of target', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all randomized participants who took at least one dose of study medication and had at least one post-randomization glycemic goal assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '330'}]}, {'type': 'Treated', 'achievements': [{'comment': 'One participant was randomized in error and did not receive study medication.', 'groupId': 'FG000', 'numSubjects': '329'}, {'comment': 'One participant was randomized in error and did not receive study medication.', 'groupId': 'FG001', 'numSubjects': '329'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '303'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Creatinine and eGFR, excluded medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '658', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Sitagliptin 100 mg administered orally once daily for 24 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo to sitagliptin administered orally once daily for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '58.3', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '9.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '178', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant in both the Sitagliptin group and Placebo group was randomized in error and did not receive study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2013-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-20', 'studyFirstSubmitDate': '2011-10-27', 'resultsFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2011-10-28', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-03-07', 'studyFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Daily Insulin Dose at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in daily insulin dose following 24 weeks of therapy (i.e., daily insulin dose at Week 24 minus daily insulin dose at baseline)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hemoglobin A1c (A1C) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change in FPG (before breakfast) following 24 weeks of therapy (i.e., FPG at Week 24 minus FPG at baseline)'}, {'measure': 'Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study', 'timeFrame': 'Up to 24 weeks', 'description': 'The fasting glucose target was defined as 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L).'}, {'measure': 'Time to Achieve the Fasting Glucose Target', 'timeFrame': 'Up to 24 weeks', 'description': 'Fasting glucose target 3 consecutive days with a fingerstick glucose of 72 to 100 mg/dL (4.0 - 5.6 mmol/L). This analysis was the Kaplan-Meier estimated 50th percentile of time (days) to first attainment of target.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0431-260&kw=0431-260&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '25820927', 'type': 'RESULT', 'citation': 'Mathieu C, Shankar RR, Lorber D, Umpierrez G, Wu F, Xu L, Golm GT, Latham M, Kaufman KD, Engel SS. A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Co-Administration of Sitagliptin with Intensively Titrated Insulin Glargine. Diabetes Ther. 2015 Jun;6(2):127-42. doi: 10.1007/s13300-015-0105-3. Epub 2015 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* has type 2 diabetes mellitus\n* has one of the following criteria:\n\n * diagnosed with diabetes after age 40 years and insulin therapy was initiated at least 3 years following diagnosis\n * if diagnosed with diabetes under age 40 years or insulin started earlier than 3 years after diagnosis, has a fasting C-peptide greater than 0.7 ng/mL\n* must be at least 18 years of age and less than or equal to 80 years of age (for participants in India: must be at least 18 years of age and less than or equal to 65 years of age)\n* on a stable regimen of insulin for at least 10 weeks with or without metformin (at least 1500 mg/day) and/or sulfonylurea for at least 10 weeks\n* is highly unlikely to become pregnant (not of reproductive potential or agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control during the study and for 14 days after the last dose of study medication\n\nExclusion Criteria:\n\n* has been treated with a dipeptidyl peptidase IV (DPP-4) inhibitor, a thiazolidinedione (TZD), or a glucagon-like peptide-1 (GLP-1) mimetic or analogue, within the past 12 weeks\n* currently on treatment with daily use (one or more injections per day) of a\n\npre-prandial short-acting or rapid-acting insulin alone or as part of a basal/bolus insulin regimen\n\n* has symptomatic hyperglycemia that requires immediate initiation, adjustment, or addition of antihyperglycemic therapy\n* has a history of 2 or more episodes of hypoglycemia resulting in seizure,\n\ncoma, or loss of consciousness, - or - has had recurrent (≥3 times per week) episodes of hypoglycemia over the past 8 weeks\n\n* has a history of ketoacidosis\n* is not appropriate for or does not agree to target a fasting glucose of 72-100 mg/dL \\[4.0-5.6 mmol/L\\]\n* is on or likely to require treatment with corticosteroids\n* has undergone a surgical procedure within 4 weeks or has planned major surgery during the study\n* is currently being treated for hyperthyroidism or is on thyroid hormone\n\ntherapy and has not been on a stable dose for at least 6 weeks\n\n* has a history of active liver disease (other than non-alcoholic hepatic\n\nsteatosis)\n\n* has had new or worsening signs or symptoms of coronary heart disease or\n\ncongestive heart failure within the past 3 months, or has any of the following\n\ndisorders within the past 3 months:\n\n* acute coronary syndrome\n* coronary artery intervention\n* stroke or transient ischemic neurological disorder\n\n * has a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 90 mm Hg\n * has human immunodeficiency virus (HIV)\n * has severe peripheral vascular disease\n * has a clinically important hematological disorder\n * has a history of malignancy that is less than 5 years from study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer\n * has a positive urine pregnancy test\n * is pregnant or breast-feeding, or is expecting to conceive or donate eggs\n\nduring the study\n\n* a user of recreational or illicit drugs or has had a recent history of drug abuse'}, 'identificationModule': {'nctId': 'NCT01462266', 'briefTitle': 'Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Alone or in Combination With Metformin', 'orgStudyIdInfo': {'id': '0431-260'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'description': 'Sitagliptin 100 mg once daily', 'interventionNames': ['Drug: Sitagliptin', 'Biological: Insulin Glargine', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to sitagliptin once daily', 'interventionNames': ['Drug: Comparator: Placebo', 'Biological: Insulin Glargine', 'Drug: Metformin']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Sitagliptin 100 mg tablet once daily for 24 weeks', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo to sitagliptin once daily for 24 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'Insulin Glargine', 'type': 'BIOLOGICAL', 'description': 'Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study.', 'armGroupLabels': ['Placebo', 'Sitagliptin']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.', 'armGroupLabels': ['Placebo', 'Sitagliptin']}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}