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Kosice","04011",{"type":56,"coordinates":1697},[1685,1686],{"lat":1686,"lon":1685},{"type":1700,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100598800","phase-3-a-research-study-to-see-how-a-weekly-insulin-insulin-icodec-helps-in-reducing-the-blood-sugar-compared-to-daily-insulin-glargine-both-in-combination-with-insulin-aspart-in-adults-with-type-1-diabetes-100598800",false,"NCT07076199","A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes","A 26-week Study Comparing the Efficacy and Safety of Once-weekly Insulin Icodec and Once-daily Insulin Glargine U100, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes","ONWARDS 11","Inclusion Criteria:\n\n* Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.\n* Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.\n* HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol\u002Fmol)), both inclusive, at screening confirmed by central laboratory analysis.\n* Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Previous participation in this study. Participation is defined as signed informed consent.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.\n* Any condition, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Anticipated initiation or anticipated change in concomitant medications (for more than 15 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with thyroid hormones, or systemic corticosteroids).\n* Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.\n* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.","ALL","18 Years",{"count":1712,"type":1713},877,"ESTIMATED","INTERVENTIONAL",[1716],"PHASE3","This study compares insulin icodec, an insulin taken once a week to insulin glargine, an insulin taken once a day. The study medicine will be investigated in participants with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. The study will last for about 8.5 months.",[1719],"Diabetes Mellitus, Type 1","2026-06-25",{"date":1722,"type":1723},"2026-06-29","ACTUAL",{"date":1725,"type":1723},"2025-08-11",{"date":1727,"type":1713},"2027-03-01",{"name":5,"class":6},196]