{"id":"toujeo-solostar","safety":{"commonSideEffects":[{"rate":null,"effect":"Hypoglycemia"},{"rate":null,"effect":"Injection site reactions"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Lipodystrophy"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Toujeo is a concentrated formulation of insulin glargine (U-300) that provides sustained, peakless insulin coverage over 24 hours. It works by mimicking endogenous insulin, activating insulin receptors on muscle, fat, and liver cells to increase glucose uptake and reduce hepatic glucose production. The U-300 concentration allows for smaller injection volumes compared to standard insulin glargine formulations.","oneSentence":"Toujeo SoloStar is a long-acting basal insulin that binds to insulin receptors to lower blood glucose by promoting glucose uptake and storage in cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:13:30.896Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Type 1 diabetes mellitus"},{"name":"Type 2 diabetes mellitus"}]},"trialDetails":[{"nctId":"NCT06671587","phase":"PHASE4","title":"iGlarLixi CGM Study in Chinese T2D Individuals After OADs","status":"RECRUITING","sponsor":"Sanofi","startDate":"2024-12-10","conditions":"Type 2 Diabetes (T2D)","enrollment":678},{"nctId":"NCT06716424","phase":"PHASE4","title":"A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sanofi","startDate":"2025-01-06","conditions":"Type 2 Diabetes","enrollment":105},{"nctId":"NCT05552859","phase":"PHASE4","title":"Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment","status":"TERMINATED","sponsor":"Sanofi","startDate":"2022-12-05","conditions":"Type 2 Diabetes Mellitus, Renal Impairment","enrollment":62},{"nctId":"NCT07070752","phase":"PHASE3","title":"Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"Geropharm","startDate":"2023-04-14","conditions":"Type 1 Diabetes Mellitis","enrollment":224},{"nctId":"NCT03371082","phase":"PHASE3","title":"Gan & Lee Insulin Glargine Target Type (1) Evaluating Research","status":"COMPLETED","sponsor":"Gan and Lee Pharmaceuticals, USA","startDate":"2017-10-31","conditions":"Diabetes Mellitus, Type 1","enrollment":576},{"nctId":"NCT03668808","phase":"PHASE4","title":"Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones.","status":"COMPLETED","sponsor":"Sansum Diabetes Research Institute","startDate":"2018-11-16","conditions":"Diabetes Mellitus, Type 1","enrollment":25},{"nctId":"NCT03703869","phase":"","title":"Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-03-06","conditions":"Diabetes","enrollment":4589},{"nctId":"NCT03371108","phase":"PHASE3","title":"Gan & Lee Insulin Glargine Target Type (2) Evaluating Research","status":"COMPLETED","sponsor":"Gan and Lee Pharmaceuticals, USA","startDate":"2017-10-31","conditions":"Diabetes Mellitus, Type 2","enrollment":567},{"nctId":"NCT03328845","phase":"PHASE4","title":"Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study)","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","startDate":"2017-01-20","conditions":"Type 1 Diabetes Mellitus","enrollment":300},{"nctId":"NCT01203774","phase":"PHASE4","title":"Comparison of SoloSTAR With a Syringe-administered Glargine Insulin in Diabetic Patients From the Hospital","status":"COMPLETED","sponsor":"University of Colorado, Denver","startDate":"2010-09","conditions":"Diabetes","enrollment":43},{"nctId":"NCT04022993","phase":"PHASE3","title":"Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients","status":"COMPLETED","sponsor":"Geropharm","startDate":"2018-07-04","conditions":"Diabetes Mellitus, Type 1, Diabetes Mellitus","enrollment":180},{"nctId":"NCT01855243","phase":"NA","title":"Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM","status":"COMPLETED","sponsor":"Cairo University","startDate":"2010-03","conditions":"Diabetes Mellitus (DM)","enrollment":63},{"nctId":"NCT02551874","phase":"PHASE3","title":"A 24-week Open-Label, Phase 3b Trial With a 28-week Extension to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin Compared to Insulin Glargine in Subjects withType 2 Diabetes Who Have Glycemic Control on Metformin","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-10-20","conditions":"Type 2 Diabetes Mellitus","enrollment":650},{"nctId":"NCT01240200","phase":"PHASE4","title":"Satisfaction of Treatment Among Elderly Patients With Insulin Therapy","status":"COMPLETED","sponsor":"Emory University","startDate":"2011-01","conditions":"Diabetes Mellitus","enrollment":49},{"nctId":"NCT02058147","phase":"PHASE3","title":"Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM","status":"COMPLETED","sponsor":"Sanofi","startDate":"2014-02","conditions":"Type 2 Diabetes","enrollment":1170},{"nctId":"NCT02058160","phase":"PHASE3","title":"Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Sanofi","startDate":"2014-01","conditions":"Type 2 Diabetes","enrollment":736},{"nctId":"NCT01476475","phase":"PHASE2","title":"Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2011-11","conditions":"Type 2 Diabetes Mellitus","enrollment":323},{"nctId":"NCT01768559","phase":"PHASE3","title":"Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2013-01","conditions":"Type 2 Diabetes","enrollment":894},{"nctId":"NCT01596504","phase":"PHASE2","title":"Pharmacodynamic Effects of Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin","status":"COMPLETED","sponsor":"Sanofi","startDate":"2012-05","conditions":"Type 2 Diabetes Mellitus","enrollment":142},{"nctId":"NCT00975286","phase":"PHASE3","title":"24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-10","conditions":"Type 2 Diabetes Mellitus","enrollment":446},{"nctId":"NCT02200991","phase":"PHASE4","title":"Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine","status":"COMPLETED","sponsor":"Sanofi","startDate":"2014-08","conditions":"Type 2 Diabetes Mellitus","enrollment":136},{"nctId":"NCT01127269","phase":"PHASE4","title":"Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-05","conditions":"Diabetes Mellitus, Type 2","enrollment":178},{"nctId":"NCT00862875","phase":"PHASE4","title":"Levemir-Body Composition and Energy Metabolism","status":"COMPLETED","sponsor":"Institut de Recherches Cliniques de Montreal","startDate":"2009-03","conditions":"Type 2 Diabetes","enrollment":42},{"nctId":"NCT01117350","phase":"PHASE4","title":"Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-07","conditions":"Diabetes Mellitus, Type 2","enrollment":978},{"nctId":"NCT01204593","phase":"PHASE4","title":"baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-11","conditions":"Diabetes Mellitus, Type 1","enrollment":206},{"nctId":"NCT01122979","phase":"PHASE4","title":"Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-07","conditions":"Diabetes Mellitus, Type 2","enrollment":72},{"nctId":"NCT01226043","phase":"PHASE4","title":"Patient Preference and Satisfaction With Insulin Glargine (Lantus) Solostar Pen vs Conventional Vial-Syringe Method of Lantus Injection Therapy in Patients With Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-10","conditions":"Diabetes Mellitus, Type 2","enrollment":405},{"nctId":"NCT01169818","phase":"PHASE4","title":"Evaluation of the Effectiveness and Safety of Physician Versus Patient-led of Insulin Glargine Initiation and Titration in Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-08","conditions":"Diabetes Mellitus, Type 2","enrollment":555},{"nctId":"NCT01079364","phase":"PHASE4","title":"Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting","status":"TERMINATED","sponsor":"Sanofi","startDate":"2010-01","conditions":"Diabetes Mellitus, Type 2","enrollment":52},{"nctId":"NCT01121835","phase":"PHASE4","title":"Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-02","conditions":"Diabetes Mellitus, Type 2","enrollment":934},{"nctId":"NCT00913367","phase":"PHASE4","title":"Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus","status":"COMPLETED","sponsor":"Handok Inc.","startDate":"2009-05","conditions":"Type 2 Diabetes Mellitus","enrollment":110},{"nctId":"NCT00965549","phase":"PHASE4","title":"Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-07","conditions":"Diabetes Mellitus, Type 2","enrollment":463},{"nctId":"NCT00851903","phase":"PHASE3","title":"Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-06","conditions":"Diabetes Mellitus, Type 2","enrollment":112},{"nctId":"NCT00751114","phase":"PHASE4","title":"Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients","status":"COMPLETED","sponsor":"Sanofi","startDate":"2008-11","conditions":"Diabetes Mellitus, Type 2","enrollment":515},{"nctId":"NCT01203111","phase":"PHASE4","title":"Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs","status":"COMPLETED","sponsor":"Sanofi","startDate":"2010-12","conditions":"Diabetes Mellitus, Type 2","enrollment":207},{"nctId":"NCT00949442","phase":"PHASE4","title":"Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-07","conditions":"Diabetes Mellitus, Type 2","enrollment":708},{"nctId":"NCT00993473","phase":"PHASE3","title":"6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes","status":"COMPLETED","sponsor":"Sanofi","startDate":"2009-10","conditions":"Type 1 Diabetes Mellitus","enrollment":125},{"nctId":"NCT01081938","phase":"PHASE4","title":"Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition","status":"TERMINATED","sponsor":"Sanofi","startDate":"2010-02","conditions":"Diabetes Mellitus, Type 2","enrollment":15},{"nctId":"NCT00857870","phase":"PHASE4","title":"Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects","status":"COMPLETED","sponsor":"GWT-TUD GmbH","startDate":"2009-03","conditions":"Type 2 Diabetes","enrollment":96}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":29,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Glargina U300"],"phase":"marketed","status":"active","brandName":"Toujeo SoloStar","genericName":"Toujeo SoloStar","companyName":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","companyId":"fundaci-n-p-blica-andaluza-para-la-investigaci-n-de-m-laga-en-biomedicina-y-salu","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Toujeo SoloStar is a long-acting basal insulin that binds to insulin receptors to lower blood glucose by promoting glucose uptake and storage in cells. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}