[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437726":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":27,"responsibleParty":49,"collaborators":26,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":26,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":26,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Insuline Glargine (U300) (Gla-300)","EXPERIMENTAL","Insulin glargine (U300) once daily for 24 weeks on top of non-insulin antidiabetic drug. Insulin dose will be adjusted according to the recommended titration algorithm",[13],"Drug: Insulin glargine (U300)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Insulin glargine (U300)","Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous",[9],[21],"HOE901 Toujeo",[23],{"name":24,"affiliation":5,"role":25},"Clinical Sciences & Operations","STUDY_DIRECTOR",null,[28,40],{"facility":29,"status":26,"city":30,"state":26,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":26},"Investigational site Number 3560003","Jaipur","302017","India","IN",{"type":35,"coordinates":36},"Point",[37,38],75.78781,26.91962,{"lat":38,"lon":37},{"facility":41,"status":26,"city":42,"state":26,"zip":43,"country":32,"countryCode":33,"cosmosGeoPoint":44,"geoPoint":48,"contacts":26},"Investigational site Number 3560013","Nashik","422002",{"type":35,"coordinates":45},[46,47],73.79096,19.99727,{"lat":47,"lon":46},{"type":50,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100437726","phase-4-evaluation-of-the-safety-and-efficacy-of-insulin-glargine-300-uml-gla-300-in-insulin-nave-patients-with-type-2-diabetes-mellitus-uncontrolled-on-oral-antihyperglycemic-drugs-100437726",false,"NCT04980027","Evaluation of the Safety and Efficacy of Insulin Glargine 300 U\u002Fml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs","Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs","SAFEGUARD","Inclusion criteria :\n\n* Participants with Type 2 diabetes mellitus\n* Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening.\n* HbA1c between 7.5% (58 mmol\u002Fmol) and 10% (86 mmol\u002Fmol) inclusive, during screening.\n\nExclusion criteria:\n\n* History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.\n* Proliferative retinopathy or maculopathy requiring treatment according to the Investigator\n* Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).\n* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","18 Years",{"count":62,"type":63},228,"ACTUAL","INTERVENTIONAL",[66],"PHASE4","Primary Objective:\n\nTo evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs\n\nSecondary Objective:\n\nTo assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)",[69],"Type 2 Diabetes Mellitus","COMPLETED","2025-09-16",{"date":73,"type":63},"2025-09-22",{"date":75,"type":63},"2021-06-07",{"date":77,"type":63},"2022-12-23",{"name":5,"class":6},2]