{"id":"pioglitazone-rescue-therapy","safety":{"commonSideEffects":[{"rate":"5–10","effect":"Weight gain"},{"rate":"5–10","effect":"Fluid retention / edema"},{"rate":null,"effect":"Hypoglycemia (when combined with insulin or sulfonylureas)"},{"rate":"5","effect":"Headache"},{"rate":"5","effect":"Upper respiratory tract infection"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a thiazolidinedione, pioglitazone binds to PPAR-γ in adipose tissue and muscle, enhancing insulin-mediated glucose uptake and reducing hepatic glucose production. This mechanism addresses insulin resistance, a core pathophysiology of type 2 diabetes. In rescue therapy contexts, it is used as an add-on agent when other antidiabetic drugs have proven insufficient.","oneSentence":"Pioglitazone activates peroxisome proliferator-activated receptor gamma (PPAR-γ) to improve insulin sensitivity and reduce blood glucose in patients with type 2 diabetes.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:26:19.032Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes mellitus (rescue/add-on therapy)"}]},"trialDetails":[{"nctId":"NCT00571519","phase":"PHASE3","title":"Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus","status":"TERMINATED","sponsor":"Daiichi Sankyo","startDate":"2007-11-14","conditions":"Type 2 Diabetes Mellitus","enrollment":94},{"nctId":"NCT01076075","phase":"PHASE3","title":"A Study to Evaluate the Safety and Efficacy of Sitagliptin 100 mg in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control (MK-0431-229)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-06-03","conditions":"Type 2 Diabetes Mellitus","enrollment":427},{"nctId":"NCT00885352","phase":"PHASE3","title":"Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2009-04-15","conditions":"Type 2 Diabetes Mellitus","enrollment":313},{"nctId":"NCT00722371","phase":"PHASE3","title":"MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-102 AM2)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-09-05","conditions":"Type 2 Diabetes Mellitus","enrollment":1615},{"nctId":"NCT00481663","phase":"PHASE2","title":"A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2003-08-19","conditions":"Type II Diabetes Mellitus","enrollment":555},{"nctId":"NCT00086502","phase":"PHASE3","title":"Pioglitazone Add-on Study in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2004-06","conditions":"Diabetes Mellitus, Type 2","enrollment":353},{"nctId":"NCT00327015","phase":"PHASE3","title":"A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2006-05","conditions":"Diabetes","enrollment":1306},{"nctId":"NCT00121667","phase":"PHASE3","title":"Study Assessing Saxagliptin Treatment In Type 2 Diabetic Subjects Who Are Not Controlled With Metformin Alone","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2005-08","conditions":"Diabetes Mellitus, Type 2","enrollment":1462},{"nctId":"NCT00295633","phase":"PHASE3","title":"A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2006-03","conditions":"Diabetes Mellitus, Type 2","enrollment":565},{"nctId":"NCT01087567","phase":"PHASE4","title":"INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes","status":"COMPLETED","sponsor":"Ohio University","startDate":"2010-07","conditions":"Type 2 Diabetes","enrollment":23},{"nctId":"NCT00680745","phase":"PHASE3","title":"Efficacy and Safety of Dapagliflozin in Combination With Glimepiride (a Sulphonylurea) in Type 2 Diabetes Patients","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2008-04","conditions":"Type 2 Diabetes","enrollment":597}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":7,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Actos"],"phase":"phase_3","status":"active","brandName":"Pioglitazone rescue therapy","genericName":"Pioglitazone rescue therapy","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pioglitazone is a small molecule used as a rescue therapy for Type 2 Diabetes Mellitus, often in combination with other medications such as metformin. It is typically used when patients have inadequate glycemic control on other treatments.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}