{"id":"alogliptin-and-insulin","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypoglycemia"},{"rate":null,"effect":"Nasopharyngitis"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Pancreatitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Alogliptin is a DPP-4 inhibitor that prevents the degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby enhancing insulin secretion and reducing glucagon in response to elevated blood glucose. The combination with insulin provides additional glycemic control through exogenous insulin replacement, targeting both endogenous and exogenous pathways of glucose homeostasis in type 2 diabetes.","oneSentence":"Alogliptin inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels and improve glucose control, while insulin provides exogenous glucose-lowering activity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:01:00.507Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes mellitus in patients inadequately controlled on insulin alone"}]},"trialDetails":[{"nctId":"NCT05220917","phase":"","title":"Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study","status":"ACTIVE_NOT_RECRUITING","sponsor":"Brigham and Women's Hospital","startDate":"2021-08-01","conditions":"Cardiovascular Events, Type2 Diabetes, Renal Disease","enrollment":781430},{"nctId":"NCT03492580","phase":"","title":"A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2018-02-22","conditions":"Diabetes Mellitus, Type 2, Cardiovascular Diseases","enrollment":714582},{"nctId":"NCT04017221","phase":"","title":"Safety of Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors Among Patients with Type 2 Diabetes","status":"COMPLETED","sponsor":"Canadian Network for Observational Drug Effect Studies, CNODES","startDate":"2018-10-01","conditions":"Diabetes Mellitus, Type 2, Urosepsis, Diabetic Ketoacidosis","enrollment":1249636},{"nctId":"NCT06449235","phase":"PHASE4","title":"Real-World Evaluation of Omarigliptin for Type 2 Diabetes Meliitus in Bangladesh","status":"NOT_YET_RECRUITING","sponsor":"Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders","startDate":"2024-09","conditions":"Type2diabetes","enrollment":938},{"nctId":"NCT03918148","phase":"","title":"Gliflozins and Cardiovascular Risk Factors in Type 2 Diabetes (GIOIA)","status":"COMPLETED","sponsor":"University of Campania Luigi Vanvitelli","startDate":"2018-01-15","conditions":"Type 2 Diabetes Mellitus","enrollment":1150},{"nctId":"NCT05161429","phase":"","title":"BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes","status":"UNKNOWN","sponsor":"Brigham and Women's Hospital","startDate":"2021-07-01","conditions":"Diabetes Mellitus, Type 2","enrollment":550000},{"nctId":"NCT02856113","phase":"PHASE3","title":"Phase 3 Alogliptin Pediatric Study","status":"COMPLETED","sponsor":"Takeda","startDate":"2016-10-14","conditions":"Diabetes Mellitus, Type 2","enrollment":152},{"nctId":"NCT02798172","phase":"NA","title":"The Effect of Alogliptin on Pulmonary Function in Obese Patients With Type 2 Diabetes Inadequately Controlled by Metformin Monotherapy","status":"COMPLETED","sponsor":"Fourth People's Hospital of Shenyang","startDate":"2014-05","conditions":"Diabetes Mellitus, Type 2","enrollment":81},{"nctId":"NCT02683226","phase":"PHASE4","title":"Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS","status":"COMPLETED","sponsor":"University Medical Centre Ljubljana","startDate":"2015-03","conditions":"Polycystic Ovary Syndrome, Insulin Resistance","enrollment":30},{"nctId":"NCT00957268","phase":"PHASE1","title":"Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-09","conditions":"Diabetes Mellitus, Type 2","enrollment":46},{"nctId":"NCT01456130","phase":"PHASE3","title":"Long-term Study of Alogliptin as an Add-on to Rapid-Acting Insulin Secretagogues in Type 2 Diabetes","status":"COMPLETED","sponsor":"Takeda","startDate":"2011-11","conditions":"Diabetes Mellitus","enrollment":67},{"nctId":"NCT01521962","phase":"PHASE3","title":"Study of Combination Therapy With SYR-322","status":"COMPLETED","sponsor":"Takeda","startDate":"2012-02","conditions":"Diabetes Mellitus","enrollment":67},{"nctId":"NCT00328627","phase":"PHASE3","title":"Efficacy and Safety of Alogliptin Combined With Pioglitazone in Treating Subjects With Type 2 Diabetes Mellitus.","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-05","conditions":"Type 2 Diabetes Mellitus","enrollment":1554},{"nctId":"NCT01023581","phase":"PHASE3","title":"Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Takeda","startDate":"2009-11","conditions":"Diabetes Mellitus, Type 2","enrollment":784},{"nctId":"NCT00755846","phase":"PHASE2","title":"Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.","status":"COMPLETED","sponsor":"Takeda","startDate":"2005-03","conditions":"Diabetes Mellitus","enrollment":265},{"nctId":"NCT00286429","phase":"PHASE3","title":"Efficacy and Safety Study of Alogliptin and Insulin in the Treatment of Type 2 Diabetes.","status":"COMPLETED","sponsor":"Takeda","startDate":"2006-02","conditions":"Diabetes Mellitus","enrollment":390}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":34,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["alogliptin","SYR110322"],"phase":"phase_3","status":"active","brandName":"Alogliptin and insulin","genericName":"Alogliptin and insulin","companyName":"Takeda","companyId":"takeda","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Alogliptin inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels and improve glucose control, while insulin provides exogenous glucose-lowering activity. Used for Type 2 diabetes mellitus in patients inadequately controlled on insulin alone.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}