Join Trial Testing Once-Weekly Insulin for Type 1 Diabetes

Trial status: Recruiting

Clinical Trials Identifier: NCT07076199

Trial Name: 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)

Diabetes Type: Type 1 diabetes

Trial Sponsor: Novo Nordisk A/S

Why is this study important?

This study is comparing the effectiveness of once-weekly insulin icodec (Awiqli) – which was recently approved in the U.S. for type 2 diabetes – and the daily insulin glargine (sold under brand names including Lantus, Basaglar, and Semglee) for people with type 1 diabetes. Insulin icodec has already been approved for people with type 1 and type 2 diabetes in Canada, Europe, and Japan.

There are many factors that make managing diabetes mentally taxing, but for people who use insulin, remembering to take a daily injection in the morning or at night can be a major source of stress. Once-weekly insulin is a modified form that allows insulin to last longer in the body, reducing the number of injections a person needs and making it easier to take the right amount of medicine.

However, once-weekly insulin cannot replace rapid-acting, mealtime insulin, so people with type 1 diabetes will always have to take an appropriate dose like insulin aspart (NovoLog) before or after they eat.

The results of previous trials in people with type 2 diabetes suggest that the hypoglycemia risk associated with insulin icodec is similar to daily insulin. The ONWARDS 11 trial will provide more evidence for the FDA to consider once-weekly insulin for people with type 1 diabetes.

How does the trial work?

Researchers are aiming to recruit 877 adults with type 1 diabetes who manage the condition with multiple daily insulin injections. Participants will be randomly assigned to take either weekly insulin icodec or daily insulin glargine. Both groups will take insulin aspart to manage blood sugar around meals.

Participants will use their assigned insulin for 26 weeks. The researchers will assess the effectiveness of the once-weekly and daily insulin by measuring participants’ A1C values at the start and end of the trial. They will also track continuous glucose monitoring (CGM) data to look for changes in time in range, time above range, and time below range. In addition, they will track the number and severity of hypoglycemic events that participants experience during the 26-week trial and for five weeks after it ends.

Are you interested in participating?

You may be eligible to participate if you are over 18 and:

• Were diagnosed with type 1 diabetes at least a year before the trial
• Have been taking multiple daily insulin injections for at least six months
• Have an A1C value between 7-10%

People who have hypoglycemia unawareness or a recent history of recurrent episodes of severe hypoglycemia are not eligible to participate. The trial is currently recruiting in many locations across the U.S., Canada, Australia, and Europe. To see if you’re eligible or for more information on enrolling, you can contact the trial recruitment centers here.

Learn more about weekly insulin here:

• New Trial Data Shows Once-Weekly Insulin Improves Time in Range
• Lilly’s Once-Weekly Insulin Equally Effective as Daily Insulin for Improving A1C
• Could Once-Weekly Insulin Help Reduce Diabetes Stigma?