Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-28 @ 8:37 PM
Study NCT ID:
NCT01357135
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D008687', 'term': 'Metformin'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}, {'id': 'D013453', 'term': 'Sulfonylurea Compounds'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, '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': "Investigators cannot disclose any results without sponsor's agreement, only on request of French Health Authorities as per French law.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The adverse events in this study were not systematically collected or assessed and therefore no direct comparison can be made between adverse events in the 3 study groups/arms.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years', 'description': 'Population of participants receiving treatment with metformin + sitagliptin or metformin + sulfonylurea or sitagliptin +/- other antihyperglycemic medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin as prescribed in routine clinical practice.', 'otherNumAtRisk': 1874, 'otherNumAffected': 0, 'seriousNumAtRisk': 1874, 'seriousNumAffected': 68}, {'id': 'EG001', 'title': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.', 'otherNumAtRisk': 733, 'otherNumAffected': 0, 'seriousNumAtRisk': 733, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': 'Sitagliptin +/- Other Antihyperglycemic Medication', 'description': 'Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.', 'otherNumAtRisk': 846, 'otherNumAffected': 0, 'seriousNumAtRisk': 846, 'seriousNumAffected': 66}], 'seriousEvents': [{'term': 'Acute Coronary Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis Erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Inflammatory bowel disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Intestinal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Heptatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anaesthetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dural tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Open wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acquired diaphragmatic eventration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, 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'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Toe amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1874, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 733, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 846, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Duration (in Months) of Initial Dual Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1874', 'groupId': 'OG000'}, {'value': '733', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin as prescribed in routine clinical practice.'}, {'id': 'OG001', 'title': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'comment': 'There were insufficient number of participants with events to estimate an upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': 'NA'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '25.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 3 years', 'description': 'The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants receiving dual therapy with metformin + sitagliptin or metformin + sulfonylurea.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Strict Changes in Initial Dual Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1874', 'groupId': 'OG000'}, {'value': '733', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin as prescribed in routine clinical practice.'}, {'id': 'OG001', 'title': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants receiving dual therapy metformin + sitagliptin or metformin + sulfonylurea.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.'}, {'id': 'FG001', 'title': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.'}, {'id': 'FG002', 'title': 'Sitagliptin +/- Other Antihyperglycemic Medication', 'description': 'Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1874'}, {'groupId': 'FG001', 'numSubjects': '733'}, {'groupId': 'FG002', 'numSubjects': '846'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1276'}, {'groupId': 'FG001', 'numSubjects': '510'}, {'groupId': 'FG002', 'numSubjects': '583'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '598'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '263'}]}]}], 'recruitmentDetails': 'This was an observational, non-randomized, prospective, longitudinal study of participants with Type 2 diabetes mellitus treated in routine clinical practice by 1,569 primary care practitioners in metropolitan France. Study participants were enrolled from July 29, 2009 to December 31, 2010. The end of study follow-up was August 31, 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1874', 'groupId': 'BG000'}, {'value': '733', 'groupId': 'BG001'}, {'value': '846', 'groupId': 'BG002'}, {'value': '3453', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.'}, {'id': 'BG001', 'title': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.'}, {'id': 'BG002', 'title': 'Sitagliptin +/- Other Antihyperglycemic Medication', 'description': 'Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.4', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '65.5', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '63.5', 'spread': '11.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '758', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}, {'value': '1441', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1108', 'groupId': 'BG000'}, {'value': '422', 'groupId': 'BG001'}, {'value': '474', 'groupId': 'BG002'}, {'value': '2004', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline gender data is missing for 8 participants in the Metformin + Sitagliptin group.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3453}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2013-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2011-05-18', 'resultsFirstSubmitDate': '2014-11-14', 'studyFirstSubmitQcDate': '2011-05-19', 'lastUpdatePostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-04', 'studyFirstPostDateStruct': {'date': '2011-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Duration (in Months) of Initial Dual Therapy', 'timeFrame': 'Up to 3 years', 'description': 'The treatment maintenance duration corresponds to the treatment maintenance and persistence duration for dual therapy combining the same agents. Withdrawal of an agent, replacement of one agent by another or addition of a third agent is perceived as a change in treatment and, hence, the end of the treatment maintenance duration for dual therapy.'}, {'measure': 'Percentage of Participants With Strict Changes in Initial Dual Therapy', 'timeFrame': 'Up to 3 years', 'description': 'Strict changes in dual therapy were defined as withdrawal of an agent, replacement of one agent by another, or the addition of a third agent. Changes in dose level were not considered strict changes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=0431-201&kw=0431-201&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '25976701', 'type': 'RESULT', 'citation': 'Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.'}]}, 'descriptionModule': {'briefSummary': 'This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes participants\n* De novo treatment (first prescription or dated within the past 8 weeks) with:\n* Metformin + sitagliptin dual therapy,\n* Metformin + sulfonylurea dual therapy,\n* Sitagliptin as part of another treatment regimen\n* Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.'}, 'identificationModule': {'nctId': 'NCT01357135', 'briefTitle': 'An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).', 'orgStudyIdInfo': {'id': '0431-201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Metformin + Sitagliptin', 'description': 'Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.', 'interventionNames': ['Drug: Metformin', 'Drug: Sitagliptin']}, {'label': 'Metformin + Sulfonylurea', 'description': 'Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.', 'interventionNames': ['Drug: Metformin', 'Drug: Sulfonylurea']}, {'label': 'Sitagliptin +/- Other Antihyperglycemic Medication', 'description': 'Participants taking sitagliptin +/- other antihyperglycemic medication (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.', 'interventionNames': ['Drug: Antihyperglycemic Medication']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'armGroupLabels': ['Metformin + Sitagliptin', 'Metformin + Sulfonylurea']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'armGroupLabels': ['Metformin + Sitagliptin']}, {'name': 'Sulfonylurea', 'type': 'DRUG', 'armGroupLabels': ['Metformin + Sulfonylurea']}, {'name': 'Antihyperglycemic Medication', 'type': 'DRUG', 'armGroupLabels': ['Sitagliptin +/- Other Antihyperglycemic Medication']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}