Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00086502
Status:
COMPLETED
Last Update Posted:
2016-02-05
First Post:
2004-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['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': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], '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'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': 'Week 0 through Week 24.', 'description': 'Other (not including serious) adverse experience results represent those events included in the primary\n\nsafety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).', 'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).', 'otherNumAtRisk': 175, 'otherNumAffected': 20, 'seriousNumAtRisk': 175, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).', 'otherNumAtRisk': 178, 'otherNumAffected': 13, 'seriousNumAtRisk': 178, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Any Infections And Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Any Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ileitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any General Disorders And Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Hepatobiliary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Immune System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Injury, Poisoning And Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Musculoskeletal And Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Non-Small Cell Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Pregnancy, Puerperium And Perinatal Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Psychiatric Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Skin And Subcutaneous Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Angioneurotic Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Any Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Atherosclerosis Obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.85', 'groupId': 'OG000', 'lowerLimit': '-0.98', 'upperLimit': '-0.72'}, {'value': '-0.15', 'groupId': 'OG001', 'lowerLimit': '-0.28', 'upperLimit': '-0.03'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.54', 'pValueComment': 'Model terms: treatment; baseline; prior antihyperglycemic\n\nagent (AHA) therapy \\[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\\]', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.7', 'groupId': 'OG000', 'lowerLimit': '-22.4', 'upperLimit': '-11.0'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '-4.3', 'upperLimit': '6.3'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-17.7', 'ciLowerLimit': '-24.3', 'ciUpperLimit': '-11.0', 'pValueComment': 'Model terms: treatment; baseline; prior antihyperglycemic agent (AHA) therapy \\[not on AHA, monotherapy with oral AHA, peroxisome proliferator-activated receptor (PPAR)-based combination therapy\\]', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '30.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '20'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Patient Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Discontinuation Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Patient Accidentally Unblinded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient In: 15-Jul-2004.\n\nLast Patient Last Visit: 28-Sep-2005\n\n71 study centers worldwide', 'preAssignmentDetails': 'Patients ≥18 years of age with type 2 diabetes mellitus and inadequate glycemic control \\[hemoglobin A1C\n\n(HbA1c) ≥7.0 and ≤10.0%\\] who were on a stable dose of pioglitazone (≥30 mg/day) after a variable\n\nscreening period were eligible to enter the 24-week study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '11.1', 'groupId': 'BG001'}, {'value': '56.2', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c (Hemoglobin A1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.0', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '0.8', '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-04', 'studyFirstSubmitDate': '2004-07-02', 'resultsFirstSubmitDate': '2010-03-30', 'studyFirstSubmitQcDate': '2004-07-02', 'lastUpdatePostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-30', 'studyFirstPostDateStruct': {'date': '2004-07-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24', 'timeFrame': 'Baseline and week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '17157112', 'type': 'BACKGROUND', 'citation': 'Rosenstock J, Brazg R, Andryuk PJ, Lu K, Stein P; Sitagliptin Study 019 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing pioglitazone therapy in patients with type 2 diabetes: a 24-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2006 Oct;28(10):1556-68. doi: 10.1016/j.clinthera.2006.10.007.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this 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'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has type 2 diabetes mellitus (T2DM)\n* Patient is 18 years of age (or older)\n* Patient is not pregnant or breast-feeding and does not plan to become pregnant for the duration of the study and poststudy follow-up period\n\nExclusion Criteria:\n\n* Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis\n* Patient required insulin within the prior 8 weeks\n* Patient is on a weight loss program and is not in the maintenance phase\n* Patient started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks\n* Patient is on or likely to require treatment with treatment with immunosuppressive agents (e.g., cyclosporin, methotrexate)\n* Patient has cirrhosis, active liver disease (other than fatty liver) or symptomatic gallbladder disease\n* Patient has chronic myopathy, or a progressive neurological or neuromuscular disorder (e.g., multiple sclerosis or polymyositis)\n* Patient has any of the following disorders within the past 6 months:\n\nAcute coronary syndrome (e.g., MI or unstable angina), Coronary artery intervention, Stroke or transient ischemic neurological disorder.\n\n* Patient has new or worsening signs or symptoms of coronary heart disease within the past 3 months\n* Patient has severe peripheral vascular disease\n* Patient has congestive heart failure\n* Patient is HIV positive\n* Patient has a clinically important hematological disorder (e.g., aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)\n* Patient has a history of neoplastic disease\n* Patient has a history of alcohol or drug abuse within the past 3 years\n* Patient has viral hepatitis (hepatitis B or C)'}, 'identificationModule': {'nctId': 'NCT00086502', 'briefTitle': 'Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind 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 Pioglitazone Therapy', 'orgStudyIdInfo': {'id': '0431-019'}, 'secondaryIdInfos': [{'id': 'Formally-A0604T2DPT'}, {'id': '2006_410'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg', 'interventionNames': ['Drug: Comparator: Sitagliptin', 'Drug: Comparator: Pioglitazone', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo', 'Drug: Comparator: Pioglitazone', 'Drug: Metformin']}], 'interventions': [{'name': 'Comparator: Sitagliptin', 'type': 'DRUG', 'otherNames': ['Januvia'], 'description': 'Sitagliptin 100 mg once daily, from Visit 4 through Visit 8. Day 1 through week 24', 'armGroupLabels': ['Sitagliptin 100 mg']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo (to match Sitagliptin 100 mg) once daily, from Visit 4 through Visit 8. Day 1 through Week 24', 'armGroupLabels': ['Placebo']}, {'name': 'Comparator: Pioglitazone', 'type': 'DRUG', 'otherNames': ['ACTOS'], 'description': 'Pioglitazone 30 mg or 45 mg once daily, Visit 2 through Visit 8', 'armGroupLabels': ['Placebo', 'Sitagliptin 100 mg']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin rescue for patients meeting\n\npre-specified glycemic criteria. Metformin 500 mg,once daily, Visit 4 through Visit 8', 'armGroupLabels': ['Placebo', 'Sitagliptin 100 mg']}]}, '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'}}}}