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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• Diagnosed with type 1 diabetes mellitus greater than or equal to (≥) 1 year before screening.
• Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) ≥ 6 months before screening.
• HbA1c from 7.0-10.0 percentage (%) (53.0-85.8 millimoles per mole (mmol/mol)), both inclusive, at screening confirmed by central laboratory analysis.
• Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles, based on the investigator's judgement.

🚫 You may not be able to join if…

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous participation in this study. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• 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.
• 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.
• 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).
• Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke's questionnaire question.
• Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.

Where this trial is running

• Cullman Clinical Trials, Cullman, Alabama, United States
• John Muir Health, Concord, California, United States
• Headlands Research California, LLC, Escondido, California, United States
• Clinical Res of Central Ca, Fresno, California, United States
• Providence Medical Foundation, Fullerton, California, United States
• Scripps Whittier Diabetes Inst, La Jolla, California, United States
• Loma Linda University Faculty Medical Clinics, Loma Linda, California, United States
• Loma Linda University Faculty Medical Clinics, Loma Linda, California, United States
• Pacific Clinical Studies, Los Alamitos, California, United States
• Los Angeles Institute for Metabolic Research, Los Angeles, California, United States
• Pasadena Clinical Trials, Pasadena, California, United States
• WestenU Health, Pomona, California, United States

+ 184 more sites.

Who to contact

Novo Nordisk · (+1) 866-867-7178 · clinicaltrials@novonordisk.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07076199.