Weekly vs Daily Insulin for Type 1 Diabetes

(ONWARDS 11 Trial)

Recruiting at 168 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Insulin

Must not be taking: Thyroid hormones, Corticosteroids

Disqualifiers: Pregnancy, Hypoglycaemic unawareness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

877 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

Adults with Type 1 Diabetes are eligible for this study. Participants will be using insulin aspart alongside the trial insulins. Specific inclusion and exclusion criteria details were not provided, so interested individuals should contact the study organizers for full eligibility requirements.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for at least 1 year.

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

I plan to start or change medication soon that affects weight or blood sugar.

Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator

Known or suspected hypersensitivity to study intervention(s) or related products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either once-weekly insulin icodec or once-daily insulin glargine, both in combination with insulin aspart

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insulin aspart
• Insulin glargine
• Insulin icodec

Trial Overview The trial is testing insulin icodec, which is taken weekly, against insulin glargine, which is taken daily. Both are combined with insulin aspart in adults with Type 1 Diabetes to compare their effectiveness in controlling blood sugar over approximately 8.5 months.

How Is the Trial Designed?

Group I: Insulin icodec + insulin aspart Experimental Treatment 2 Interventions

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

Group II: Insulin glargine+ insulin aspart Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen