Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT00305604
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2006-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
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'}], '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': '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': {'eventGroups': [{'id': 'EG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.', 'otherNumAffected': 4, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.', 'otherNumAffected': 6, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Any Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Any Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastroesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lower Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Mycobacterium Avium Complex Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Upper Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Neoplasms benign, malignant and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Squamous Cell Carcinoma Of Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bladder Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pelvic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Any Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 102, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 104, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-0.69', 'upperLimit': '-0.25'}, {'value': '0.23', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.47'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.70', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '-0.47', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.81', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\\< 75/\\>= 75 yr); baseline creatinine clearance (\\< 50/\\>= 50 mL/min)'}], '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': '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. For FAS patients with no data at Week 24, the last 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': '96', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.2', 'groupId': 'OG000', 'lowerLimit': '-28.9', 'upperLimit': '-3.6'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '23.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-26.8', 'ciLowerLimit': '-40.0', 'ciUpperLimit': '-13.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '45.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\\< 75/\\>= 75 yr); baseline creatinine clearance (\\< 50/\\>= 50 mL/min)'}], '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. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-52.1', 'groupId': 'OG000', 'lowerLimit': '-73.6', 'upperLimit': '-30.7'}, {'value': '8.9', 'groupId': 'OG001', 'lowerLimit': '-12.4', 'upperLimit': '30.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-61.0', 'ciLowerLimit': '-82.1', 'ciUpperLimit': '-40.0', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '63.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\\< 75/\\>= 75 yr); baseline creatinine clearance (\\< 50/\\>= 50 mL/min)'}], '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. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24.'}, {'type': 'SECONDARY', 'title': 'Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.7', 'groupId': 'OG000', 'lowerLimit': '-34.2', 'upperLimit': '-17.1'}, {'value': '-2.1', 'groupId': 'OG001', 'lowerLimit': '-10.7', 'upperLimit': '6.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-23.5', 'ciLowerLimit': '-32.6', 'ciUpperLimit': '-14.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '25.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment; baseline; prior anti-hyperglycemic therapy (yes/no); age (\\< 75/\\>= 75 yr); baseline creatinine clearance (\\< 50/\\>= 50 mL/min)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1', 'description': 'Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.', '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. For FAS patients with no data at Day 7, the last observed measurement was carried forward to Day 7. Patients had the option to participate in self monitoring of glucose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient In: 30-MAR-2006\n\nLast Patient Last Visit: 12-MAR-2008\n\n60 medical clinics in the United States.', 'preAssignmentDetails': 'Community dwelling patients ≥ 65 years of age with a diagnosis of type 2 diabetes with hemoglobin A1c (HbA1c) ≥ 7% and ≤ 10% on diet and exercise were eligible to participate. Following a variable duration screening period, patients were randomized in a 1:1 ratio to sitagliptin 100 mg q.d. (or 50 mg q.d. based on creatinine clearance) and placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin', 'description': 'Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to \\< 50 mL/min at any time during the study.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Sitagliptin-matching placebo tablets.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '72.1', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '71.9', 'spread': '6.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'HbA1c (Hemoglobin A1c)', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '7.8', 'spread': '0.7', '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': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2006-03-20', 'resultsFirstSubmitDate': '2009-02-24', 'studyFirstSubmitQcDate': '2006-03-20', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-19', 'studyFirstPostDateStruct': {'date': '2006-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}], '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.'}, {'measure': 'Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline at Week 24 is defined as Week 24 minus Week 0.'}, {'measure': 'Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week', 'timeFrame': 'Week 1', 'description': 'Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '21428727', 'type': 'RESULT', 'citation': 'Barzilai N, Guo H, Mahoney EM, Caporossi S, Golm GT, Langdon RB, Williams-Herman D, Kaufman KD, Amatruda JM, Goldstein BJ, Steinberg H. Efficacy and tolerability of sitagliptin monotherapy in elderly patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011 May;27(5):1049-58. doi: 10.1185/03007995.2011.568059. Epub 2011 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise\n* Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes\n* History of ketoacidosis or requires insulin use\n* Alanine aminotransferase / aspartate aminotransferase \\> 2.5 X ULN, triglycerides \\> 600 mg/dL, creatinine clearance \\< 35 mL/min\n* Fasting plasma glucose consistently \\> 260 mg/dL\n* Poorly controlled hypertension'}, 'identificationModule': {'nctId': 'NCT00305604', 'briefTitle': 'Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '0431-047'}, 'secondaryIdInfos': [{'id': 'MK0431-047'}, {'id': '2006_003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'sitagliptin', 'interventionNames': ['Drug: sitagliptin phosphate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'sitagliptin phosphate', 'type': 'DRUG', 'otherNames': ['MK0431'], 'description': 'Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'sitagliptin matching placebo for up to a 24-wk treatment period.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}