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 (ONWARDS 11)

Novo Nordisk

Status and phase: Begins enrollment this month; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin glargine; Drug: Insulin icodec; Drug: Insulin aspart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07076199

2024-519945-31 (Other Identifier)

U1111-1310-7017 (Other Identifier)

NN1436-8182

Details and patient eligibility

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.

Enrollment: 877 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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877 participants in 2 patient groups

Insulin icodec + insulin aspart

Experimental group

Description:

Participants will receive subcutaneously once weekly insulin icodec in combination with 2-4 times daily insulin aspart .

Treatment:

Drug: Insulin aspart

Drug: Insulin icodec

Insulin glargine+ insulin aspart

Active Comparator group

Description:

Participants will receive subcutaneously once daily insulin glargine in combination with 2-4 times daily insulin aspart.

Treatment:

Drug: Insulin aspart

Drug: Insulin glargine