{"id":"pioglitazone-simvastatin","safety":{"commonSideEffects":[{"rate":"5–15","effect":"Fluid retention / edema"},{"rate":"2–5","effect":"Weight gain"},{"rate":"1–3","effect":"Myalgia"},{"rate":"1–5","effect":"Hypoglycemia"},{"rate":"1–3","effect":"Elevated liver enzymes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pioglitazone is a thiazolidinedione that activates peroxisome proliferator-activated receptor gamma (PPAR-γ), improving insulin sensitivity and reducing hepatic glucose production. Simvastatin is a statin that inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol and cardiovascular risk. Together, they address both glycemic control and lipid management in patients with type 2 diabetes and dyslipidemia.","oneSentence":"This combination reduces blood glucose through insulin sensitization (pioglitazone) and lowers cholesterol by inhibiting HMG-CoA reductase (simvastatin).","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:00:24.802Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 2 diabetes mellitus with dyslipidemia"}]},"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":"NCT00720577","phase":"EARLY_PHASE1","title":"Study to Evaluate the Effect of Simvastatin, Losartan and Pioglitazone on Patients With Peripheral Arterial Disease.","status":"COMPLETED","sponsor":"Medtronic Endovascular","startDate":"2005-12","conditions":"Peripheral Arterial Disease","enrollment":164},{"nctId":"NCT00531882","phase":"NA","title":"Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2007-09","conditions":"Cystic Fibrosis","enrollment":25},{"nctId":"NCT00000620","phase":"PHASE3","title":"Action to Control Cardiovascular Risk in Diabetes (ACCORD)","status":"COMPLETED","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","startDate":"1999-09","conditions":"Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia","enrollment":10251},{"nctId":"NCT00306826","phase":"PHASE4","title":"Pioglitazone in Impaired Glucose Tolerance","status":"WITHDRAWN","sponsor":"University of Leipzig","startDate":"","conditions":"Glucose Metabolism Disorders","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"pioglitazone + simvastatin","genericName":"pioglitazone + simvastatin","companyName":"University of Leipzig","companyId":"university-of-leipzig","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination reduces blood glucose through insulin sensitization (pioglitazone) and lowers cholesterol by inhibiting HMG-CoA reductase (simvastatin). Used for Type 2 diabetes mellitus with dyslipidemia.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}