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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

NCT07076199

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Type 1

Interventions: Insulin icodec, Insulin glargine, Insulin aspart

Countries: United States, Australia, Canada, Germany, Poland, Puerto Rico, Romania, Slovakia

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (196)

Cullman, Alabama, United States
Concord, California, United States
Escondido, California, United States
Fresno, California, United States
Fullerton, California, United States
La Jolla, California, United States
Loma Linda, California, United States
Loma Linda, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Pomona, California, United States
Pomona, California, United States
San Diego, California, United States
San Mateo, California, United States
Santa Clarita, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Englewood, Colorado, United States
Englewood, Colorado, United States
Golden, Colorado, United States
Fleming Island, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
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