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 trial tests a new insulin treatment for people with type 1 diabetes. It compares a once-a-week insulin, insulin icodec, with a daily insulin, insulin glargine, to determine which controls blood sugar more effectively. Participants will also use insulin aspart several times a day. The study seeks individuals who have had type 1 diabetes for at least a year and already use daily insulin shots. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that you should not start or change any medications that affect weight or blood sugar for more than 15 days. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin icodec, taken once a week, is as safe as daily insulins like insulin glargine. Studies found it effective in controlling blood sugar with a lower risk of low blood sugar. This suggests it might be as safe as the daily insulins many people with diabetes already use.

Insulin glargine, a commonly used daily insulin, has been approved for a long time. Its safety profile is well-known, with most side effects being mild, such as low blood sugar or reactions at the injection site.

In summary, both insulin icodec and insulin glargine appear well-tolerated, with insulin icodec offering a promising once-weekly alternative to daily injections. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about insulin icodec combined with insulin aspart because it offers a unique approach to managing Type 1 diabetes. Unlike the standard of care, which often requires daily insulin injections like insulin glargine, insulin icodec is administered just once a week. This could significantly reduce the burden of daily injections for patients, making diabetes management more convenient and potentially improving adherence. Additionally, combining it with insulin aspart maintains the flexibility needed for mealtime glucose control.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

This trial will compare weekly and daily insulin regimens for type 1 diabetes. Research has shown that insulin icodec, taken once a week, controls blood sugar levels as effectively as daily insulin treatments like degludec for people with type 1 diabetes. Studies have demonstrated that patients using icodec experience similar improvements in HbA1c, which measures average blood sugar over time, as those using daily insulin. Additionally, insulin icodec may lower the risk of hypoglycemia, a condition where blood sugar drops too low. Insulin icodec remains active in the body longer, allowing for steady blood sugar control, making it a promising option for less frequent dosing. Overall, insulin icodec is as effective as daily treatments in managing blood sugar, with a potentially lower risk of some side effects. ^{1 2 3 6 7}

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

Citations

1. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/1882-LB/155182/1882-LB-Efficacy-and-Safety-Outcomes-with-Once

1882-LB: Efficacy and Safety Outcomes with Once-Weekly ... Conclusion: Similar to degludec, when used as part of a basal-bolus regimen in T1D, once-weekly icodec may offer a lower risk of hypoglycemia ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11855992/

Icodec ONWARDS: A review of the first once-weekly ... Insulin icodec has demonstrated effective glycemic management and a safety profile comparable to daily basal insulins. Its extended half-life and steady-state ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)02179-7/fulltext

a phase 3a, randomised, open-label, treat-to-target trial In adults with type 1 diabetes, once-weekly icodec showed non-inferiority to once-daily degludec in HbA1c reduction at week 26, with ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16328

Efficacy and hypoglycaemia outcomes with once‐weekly ... The efficacy and hypoglycaemia profile of icodec versus once-daily comparators was generally consistent across ONWARDS trials irrespective of background GLP-1 ...

5. academic.oup.com academic.oup.com/jcem/article/110/11/e3596/8086419

Efficacy and Hypoglycemia Profile of Once-weekly Insulin ... This post hoc analysis evaluated the impact of age, ethnicity, and race on efficacy and hypoglycemia outcomes with once-weekly insulin icodec (icodec) vs ...

6. link.springer.com link.springer.com/article/10.1007/s40265-025-02201-0

Clinical Use of Once-Weekly Insulin Icodec A post hoc analysis of ONWARDS 1–5 showed that icodec had consistent efficacy and hypoglycemia outcomes versus OD comparators among adults with ...

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.16231

Efficacy and hypoglycaemia outcomes with once‐weekly ... Efficacy and hypoglycaemia outcomes of icodec versus once-daily comparators were generally consistent among adults with T2D, regardless of kidney function.