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

Recruiting now · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT07076199

Run by

Novo Nordisk A/S

People needed

877

Starts

2025-08-11

Expected to finish

2027-03-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• Profound Research LLC — Farmington Hills, Michigan, United States (enrolling)
• NYU Langone Orthopedic Center — New York, New York, United States (enrolling)
• Latin Clinical Trial Ctr — Tamarac, Florida, United States (enrolling)
• Brigham & Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Albuquerque Clinical Trials Inc. — Albuquerque, New Mexico, United States (enrolling)
• NYC Research, Inc. — New York, New York, United States (enrolling)
• Center for Diab,Obes & Metab — Pembroke Pines, Florida, United States (enrolling)
• Hanson Clinical Research Center — Port Charlotte, Florida, United States (enrolling)
• Iowa Diabetes Research — West Des Moines, Iowa, United States (enrolling)
• MedStar Health Research Institute — Olney, Maryland, United States (enrolling)
• QCR Network — Omaha, Nebraska, United States (enrolling)
• Palm Research Center Inc. — Las Vegas, Nevada, United States (enrolling)
• Loma Linda University Faculty Medical Clinics — Loma Linda, California, United States (enrolling)
• Mills Health Center — San Mateo, California, United States (enrolling)
• Center for Endocrine DM and Metabolic Disorders — Santa Clarita, California, United States (enrolling)
• Clinical Res of Central Ca — Fresno, California, United States (enrolling)
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States (enrolling)
• SRA Trials-Broward — Pembroke Pines, Florida, United States (enrolling)
• John Muir Health — Concord, California, United States (enrolling)
• Centricity Research Columbus — Columbus, Georgia, United States (enrolling)
• Northeast Research Institute — Fleming Island, Florida, United States (enrolling)
• Pasadena Clinical Trials — Pasadena, California, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• University at Buffalo — Williamsville, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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