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Weekly Insulin for Type 1 Diabetes Study

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Insulin

Novo Nordisk is recruiting people to take part in a research study to see how a weekly insulin compares to daily insulin in adults with type 1 diabetes.

Purpose of the study:

The study (ONWARDS-11) aims to evaluate the effectiveness and safety of once weekly insulin icodec, compared to standard once daily insulin in adults with type 1 diabetes, by exploring how well insulin icodec controls blood glucose when used with usual mealtime insulin.

Participants are randomly assigned to receive either the weekly or daily basal insulin while continuing their regular mealtime dosing.

During the study, participants need to perform daily blood glucose checks, record insulin use in an electronic diary and wear a continuous glucose monitoring device.

The trial runs for approximately 8.5 months and requires up to 19 onsite visits, averaging about 45 minutes.

Recruitment for the study will close on 13 April 2026. The final study visit is planned for 28 December 2026.

What are the benefits in taking part in this study?

This research is important in helping evaluate whether once weekly insulin can simplify diabetes management and improve treatment satisfaction. The results may help shape future treatment options and advance care for people with type 1 diabetes.

To be eligible to participate, you must be:

  • age 18 years or above
  • diagnosed with type 1 diabetes mellitus for more than a year
  • currently being treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) for more than 6 months
  • HbA1c between 7.0–10.0% (53.0–85.8 mmol/mol), both inclusive, as confirmed by central laboratory analysis
  • ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles

Participants will be required to attend one of the following study sites:

  • Royal Melbourne Hospital
  • Austin Health
  • St Vincent’s Hospital Melbourne

For more information on the study from any of these sites, please contact the following people:

For further information, click here

This study has received ethical approval from St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC) Reference: 095/25

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