{"id":"placebo-mk-0431-ono-5435","safety":{"commonSideEffects":[{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Hypoglycemia"}]},"_chembl":{"chemblId":"CHEMBL580144","moleculeType":"Small molecule","molecularWeight":"439.97"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DPP-4 inhibitors block the enzyme that degrades glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. This leads to increased insulin secretion and decreased glucagon secretion in a glucose-dependent manner, resulting in improved glycemic control without causing hypoglycemia.","oneSentence":"MK-0431/ONO-5435 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:27:56.136Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes mellitus"}]},"trialDetails":[{"nctId":"NCT01405911","phase":"PHASE2","title":"Dose Response Finding Study of MK-0431/ONO-5435 in Japanese Subjects With Impaired Glucose Tolerance (MK-0431-105)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-08-16","conditions":"Glucose Intolerance","enrollment":242},{"nctId":"NCT01545388","phase":"PHASE3","title":"Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-02-23","conditions":"Type 2 Diabetes Mellitus","enrollment":337},{"nctId":"NCT00837577","phase":"PHASE3","title":"MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-02-05","conditions":"Diabetes Mellitus, Non-Insulin-Dependent","enrollment":133},{"nctId":"NCT01517321","phase":"PHASE3","title":"MK-0431/ONO-5435 Phase III Clinical Trial-Rapid-acting Insulin Secretagogue Add-on Study in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"","conditions":"Type 2 Diabetes","enrollment":""},{"nctId":"NCT00854035","phase":"PHASE3","title":"MK-0431/ONO-5435 Phase III Clinical Trial - Insulin Add-on Study for Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2009-02","conditions":"Type 2 Diabetes Mellitus","enrollment":266},{"nctId":"NCT00363519","phase":"PHASE3","title":"Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2006-08","conditions":"Type 2 Diabetes Mellitus","enrollment":195},{"nctId":"NCT00363948","phase":"PHASE3","title":"Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2006-08","conditions":"Type 2 Diabetes Mellitus","enrollment":188}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Placebo, MK-0431/ONO-5435","genericName":"Placebo, MK-0431/ONO-5435","companyName":"Ono Pharmaceutical Co. Ltd","companyId":"ono-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MK-0431/ONO-5435 is a dipeptidyl peptidase-4 (DPP-4) inhibitor that increases incretin hormone levels to improve blood glucose control in type 2 diabetes. Used for Type 2 diabetes mellitus.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}