{"id":"human-regular-u-500-insulin","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypoglycemia"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Lipodystrophy"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Allergic reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a five-fold concentrated form of human regular (short-acting) insulin, allowing patients to inject smaller volumes while receiving higher doses. It works by binding to insulin receptors on muscle, fat, and liver cells, facilitating glucose transport into cells and promoting glycogen synthesis while inhibiting gluconeogenesis. The U-500 concentration is particularly useful for insulin-resistant patients requiring large daily doses.","oneSentence":"Human Regular U-500 Insulin is a concentrated insulin formulation that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:40:10.981Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 1 diabetes mellitus"},{"name":"Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses)"}]},"trialDetails":[{"nctId":"NCT05754424","phase":"PHASE1","title":"AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study","status":"COMPLETED","sponsor":"Arecor Limited","startDate":"2023-02-27","conditions":"Diabetes Mellitus, Type 2","enrollment":41},{"nctId":"NCT02588950","phase":"PHASE1","title":"A Study of U-500 Insulin (LY041001) in Participants With Type 2 Diabetes","status":"TERMINATED","sponsor":"Eli Lilly and Company","startDate":"2016-01-12","conditions":"Diabetes Mellitus, Type 2","enrollment":11},{"nctId":"NCT02561078","phase":"PHASE3","title":"An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2015-10-20","conditions":"Type 2 Diabetes Mellitus","enrollment":420},{"nctId":"NCT01774968","phase":"PHASE4","title":"Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2013-02","conditions":"Diabetes Mellitus, Type 2","enrollment":325}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":19,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["LY041001","Humulin R","U-500R"],"phase":"marketed","status":"active","brandName":"Human Regular U-500 Insulin","genericName":"Human Regular U-500 Insulin","companyName":"Eli Lilly and Company","companyId":"eli-lilly","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Human Regular U-500 Insulin is a concentrated insulin formulation that binds to insulin receptors on cells to promote glucose uptake and utilization, lowering blood glucose levels. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus (particularly in insulin-resistant patients requiring high doses).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}