RecruitingDiabetes Mellitus, Type 1

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

Eligible age

18+ yrs

Accepts

All genders

Locations

31 states

Healthy volunteers

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About this study

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.

Sponsor: Novo Nordisk A/S

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.