Oral Semaglutide for Type 2 Diabetes in Youth
(PIONEER TEENS Trial)

Recruiting in Palo Alto (17 mi)

+139 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new diabetes medicine called semaglutide. It focuses on children and teenagers with type 2 diabetes to see if the new medicine is safe and effective. Semaglutide helps control blood sugar levels, which is crucial for managing diabetes. It has been shown to improve blood sugar control and promote weight loss in patients with type 2 diabetes.

Eligibility Criteria

This trial is for children and teenagers aged 10 to under 18 with type 2 diabetes, who are on a stable dose of insulin or metformin. They must have an HbA1c level between 6.5%-11.0%. Participants cannot join if they have type 1 diabetes, certain diabetes-related antibodies, or other forms of diabetes like MODY.

Inclusion Criteria

I have been on a stable dose of metformin and basal insulin for at least 30 days.

I am between 10 and 17 years old.

Informed consent from parent(s) or legally acceptable representative (LAR) and child assent from the subject obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

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Exclusion Criteria

I have positive IA-2 or anti-GAD antibodies.

I have been diagnosed with MODY.

I have been diagnosed with type 1 diabetes.

Participant Groups

The study tests oral semaglutide (a new medicine) against a placebo (dummy medicine). It aims to see how effective and safe semaglutide is in young people with type 2 diabetes over approximately one year, involving clinic visits and phone calls.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Semaglutide - max. tolerated doseExperimental Treatment1 Intervention

Participants will receive semaglutide tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.

Group II: Placebo (semaglutide)Placebo Group1 Intervention

Participants will receive semaglutide placebo tablets once daily in addition to background treatment with metformin or basal insulin or both, in addition to diet and exercise.