Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT00094757
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2004-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
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'}]}}, '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 rescue medication if they met specific glycemic goals. SAEs include 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 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.', 'otherNumAtRisk': 205, 'otherNumAffected': 70, 'seriousNumAtRisk': 205, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.', 'otherNumAtRisk': 206, 'otherNumAffected': 55, 'seriousNumAtRisk': 206, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.', 'otherNumAtRisk': 110, 'otherNumAffected': 37, 'seriousNumAtRisk': 110, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Glycosylated Haemoglobin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Arteriosclerosis Coronary Artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Atrioventricular Block Complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Complication Of Device Insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Polytraumatism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Potassium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Blood Sodium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Colon Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Metastases To Bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Thyroid Adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Thyroid Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Haemorrhagic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vertebrobasilar Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Bladder Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Leriche Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 205, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}], '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 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.48', 'groupId': 'OG000', 'lowerLimit': '-0.61', 'upperLimit': '-0.35'}, {'value': '-0.36', 'groupId': 'OG001', 'lowerLimit': '-0.48', 'upperLimit': '-0.23'}, {'value': '0.12', 'groupId': 'OG002', 'lowerLimit': '-0.05', 'upperLimit': '0.30'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.39', 'pValueComment': 'Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.90', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.48', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.90', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment, baseline, prior anti-hyperglycemic therapy status (on vs. not on prior therapy)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0-18', 'description': 'Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.', 'unitOfMeasure': 'percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.7', 'groupId': 'OG000', 'lowerLimit': '-19.1', 'upperLimit': '-6.3'}, {'value': '-9.9', 'groupId': 'OG001', 'lowerLimit': '-16.2', 'upperLimit': '-3.5'}, {'value': '7.0', 'groupId': 'OG002', 'lowerLimit': '-1.8', 'upperLimit': '15.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.7', 'ciLowerLimit': '-30.5', 'ciUpperLimit': '-8.9', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '45.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment, baseline, prior anti-hyperglycemic therapy status'}, {'pValue': '<0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.9', 'ciLowerLimit': '-27.6', 'ciUpperLimit': '-6.1', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '45.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Model terms: treatment, baseline, prior anti-hyperglycemic therapy status'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0-18', 'description': 'The change from baseline reflects the Week 18 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 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in A1C at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'groupId': 'OG000', 'lowerLimit': '-0.42', 'upperLimit': '-0.14'}, {'value': '-0.19', 'groupId': 'OG001', 'lowerLimit': '-0.33', 'upperLimit': '-0.05'}, {'value': '-0.87', 'groupId': 'OG002', 'lowerLimit': '-1.08', 'upperLimit': '-0.66'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0-54', 'description': 'A1C is measured as percent. Thus this change from baseline reflects the Week 54 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 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FPG at Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'OG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.5', 'groupId': 'OG000', 'lowerLimit': '-11.5', 'upperLimit': '0.5'}, {'value': '-0.7', 'groupId': 'OG001', 'lowerLimit': '-6.7', 'upperLimit': '5.3'}, {'value': '-28.0', 'groupId': 'OG002', 'lowerLimit': '-37.1', 'upperLimit': '-18.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 0-54', 'description': 'The change from baseline reflects the Week 54 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 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'FG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'FG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '206'}, {'groupId': 'FG002', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '144'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Patient Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol specified discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'First Patient In: 15-Oct-2004. Last Patient Last Visit: 28-Apr-2006. 60 medical clinics in the United States (US), 37 in 4 countries in Europe, and 17 in 5 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 ≥7% and ≤10.0%) on diet and exercise alone were eligible to enter the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '521', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sitagliptin 100 mg', 'description': 'The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'BG001', 'title': 'Sitagliptin 200 mg', 'description': 'The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.'}, {'id': 'BG002', 'title': 'Placebo/Pioglitazone', 'description': 'The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.5', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '55.5', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '55.1', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '283', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '356', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hemoglobin A1C (A1C)', 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '8.1', 'spread': '0.9', 'groupId': 'BG003'}]}]}], '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': 521}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2006-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-20', 'studyFirstSubmitDate': '2004-10-22', 'resultsFirstSubmitDate': '2010-06-22', 'studyFirstSubmitQcDate': '2004-10-22', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-06-22', 'studyFirstPostDateStruct': {'date': '2004-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in A1C at Week 18', 'timeFrame': 'Weeks 0-18', 'description': 'Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in FPG at Week 18', 'timeFrame': 'Weeks 0-18', 'description': 'The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.'}, {'measure': 'Change From Baseline in A1C at Week 54', 'timeFrame': 'Weeks 0-54', 'description': 'A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.'}, {'measure': 'Change From Baseline in FPG at Week 54', 'timeFrame': 'Weeks 0-54', 'description': 'The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '17001471', 'type': 'BACKGROUND', 'citation': 'Raz I, Hanefeld M, Xu L, Caria C, Williams-Herman D, Khatami H; Sitagliptin Study 023 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy in patients with type 2 diabetes mellitus. Diabetologia. 2006 Nov;49(11):2564-71. doi: 10.1007/s00125-006-0416-z. Epub 2006 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness 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 at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus\n\nExclusion Criteria:\n\n* Younger than 18 years of age or older than 75\n* Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate"}, 'identificationModule': {'nctId': 'NCT00094757', 'briefTitle': 'An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control', 'orgStudyIdInfo': {'id': '0431-023'}, 'secondaryIdInfos': [{'id': '2004_045'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sitagliptin 100 mg', 'description': 'Sitagliptin 100 mg', 'interventionNames': ['Drug: Comparator: sitagliptin 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sitagliptin 200 mg', 'description': 'Sitagliptin 200 mg', 'interventionNames': ['Drug: Comparator: sitagliptin 200 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Pioglitazone', 'description': 'Placebo/Pioglitazone', 'interventionNames': ['Drug: Comparator: placebo', 'Drug: Comparator: pioglitazone']}], 'interventions': [{'name': 'Comparator: sitagliptin 100 mg', 'type': 'DRUG', 'description': 'sitagliptin 100 mg oral tablet once daily for 54 weeks', 'armGroupLabels': ['Sitagliptin 100 mg']}, {'name': 'Comparator: sitagliptin 200 mg', 'type': 'DRUG', 'description': 'sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks', 'armGroupLabels': ['Sitagliptin 200 mg']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'placebo oral tablet once daily during Phase A (Weeks 0-18)', 'armGroupLabels': ['Placebo/Pioglitazone']}, {'name': 'Comparator: pioglitazone', 'type': 'DRUG', 'description': 'pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)', 'armGroupLabels': ['Placebo/Pioglitazone']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}