Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-02 @ 2:19 AM
Study NCT ID:
NCT00106704
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2005-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Canada', 'Costa Rica', 'Czechia', 'Denmark', 'France', 'Guatemala', 'Hong Kong', 'Israel', 'Italy', 'Mexico', 'Norway', 'Peru', 'Philippines', 'Portugal', 'South Korea', 'Spain', 'Sweden', 'Taiwan', 'Thailand', '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'}]}}, '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': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Weeks 0 to 54', 'description': 'Patients received glycemic rescue medication if they met specific glycemic goals. SAEs includes events that occurred either before or after receiving rescue medication. Other AEs only includes those AEs that occurred prior to a patient receiving rescue medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).', 'otherNumAtRisk': 222, 'otherNumAffected': 66, 'seriousNumAtRisk': 222, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Placebo/ Pioglitazone', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).', 'otherNumAtRisk': 219, 'otherNumAffected': 57, 'seriousNumAtRisk': 219, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Coronary Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ischaemic Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Multi-Organ Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diabetic Foot Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Polytraumatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Lumbar Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Glioblastoma Multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Small Cell Lung Cancer Stage Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Squamous Cell Carcinoma Of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cerebellar Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Completed Suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Interstitial Lung Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 219, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in A1C at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}, {'id': 'OG001', 'title': 'Placebo/ Pioglitazone', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000', 'lowerLimit': '-0.57', 'upperLimit': '-0.34'}, {'value': '0.28', 'groupId': 'OG001', 'lowerLimit': '0.17', 'upperLimit': '0.40'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.74', 'ciLowerLimit': '-90.0', 'ciUpperLimit': '-0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment, stratum (on metformin or not), baseline A1C', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}, {'id': 'OG001', 'title': 'Placebo/ Pioglitazone', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'groupId': 'OG000', 'lowerLimit': '-10.2', 'upperLimit': '1.4'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '21.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.1', 'ciLowerLimit': '-28.4', 'ciUpperLimit': '-11.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment, stratum (on metformin or not at Visit 3), baseline A1C', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}, {'id': 'FG001', 'title': 'Placebo/ Pioglitazone', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '151'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Planned major surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient Received Glycemic Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Unable to re-enter US', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Laboratory test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First Patient In: 27-Apr-2005. Last Patient Last Visit: 09-Jan-2007. 27 medical clinics in the United States (US), 25 in 11 countries in Europe, and 22 in 11 countries in the rest of the world.', 'preAssignmentDetails': 'Patients 18-75 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c \\[A1C\\] ≥7.5% and ≤10.5%) at screening or after treatment with glimepiride (≥4 mg) alone or in combination with metformin (≥1500 mg) for a dose stable period of up to 10 weeks were eligible to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}, {'id': 'BG001', 'title': 'Placebo/ Pioglitazone', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '9.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fasting Plasma Glucose (FPG)', 'classes': [{'categories': [{'measurements': [{'value': '180.9', 'spread': '37.7', 'groupId': 'BG000'}, {'value': '181.6', 'spread': '42.5', 'groupId': 'BG001'}, {'value': '181.2', 'spread': '40.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin A1C (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.34', 'spread': '0.76', 'groupId': 'BG000'}, {'value': '8.34', 'spread': '0.74', 'groupId': 'BG001'}, {'value': '8.34', 'spread': '0.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2005-03-29', 'resultsFirstSubmitDate': '2010-11-19', 'studyFirstSubmitQcDate': '2005-03-29', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-19', 'studyFirstPostDateStruct': {'date': '2005-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in A1C at Week 24', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FPG at Week 24', 'timeFrame': 'Baseline and 24 Weeks', 'description': 'The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '17593236', 'type': 'BACKGROUND', 'citation': 'Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Type 2 Diabetes Mellitus with inadequate glycemic control\n\nExclusion Criteria:\n\n* Patients with Type 1 Diabetes Mellitus'}, 'identificationModule': {'nctId': 'NCT00106704', 'briefTitle': 'Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin', 'orgStudyIdInfo': {'id': '0431-035'}, 'secondaryIdInfos': [{'id': '2005_009'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin', 'description': 'Sitagliptin 10 mg tablet daily for 54 weeks', 'interventionNames': ['Drug: Comparator: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/ Pioglitazone', 'description': 'Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks', 'interventionNames': ['Drug: Comparator: Placebo', 'Drug: Comparator: Pioglitazone']}], 'interventions': [{'name': 'Comparator: Sitagliptin', 'type': 'DRUG', 'description': 'sitagliptin 10 mg tablet, once daily for 54 weeks', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo oral tablet once daily for 24 weeks', 'armGroupLabels': ['Placebo/ Pioglitazone']}, {'name': 'Comparator: Pioglitazone', 'type': 'DRUG', 'description': 'Pioglitazone 30 mg tablet once daily for 30 weeks', 'armGroupLabels': ['Placebo/ Pioglitazone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}