A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PIONEER TEENS)

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Oral semaglutide; Drug: Placebo (semaglutide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04596631

U1111-1218-1527 (Other Identifier)

2018-002952-34 (Registry Identifier)

NN9924-4437

Details and patient eligibility

About

This study compares 2 medicines for type 2 diabetes: semaglutide (new medicine) and a dummy medicine (placebo). Semaglutide will be tested to see how well it works compared to the dummy medicine. The study will also test if semaglutide is safe in children and teenagers. Participants will either get semaglutide or the dummy medicine - which one is decided by chance. Participants will take 1 tablet of the study medicine every morning on an empty stomach. They have to wait 30 minutes before they eat, drink or take any other medication by mouth. The study will last for about 1 year and 3 months (66 weeks). Participants will have 12 clinic visits and 8 phone calls with the study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions.

Enrollment: 132 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Male or female, aged 10 to below 18 years at the day of randomisation
• HbA1c 6.5%-11.0% (47-97 mmol/mol) (both inclusive)
• Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:
• stable metformin dose (stable metformin dose is defined as at least 1000 mg daily or the maximum tolerated dose for 56 days or longer prior to screening) or
• stable metformin dose and a stable dose of basal insulin (stable dose of basal insulin is defined as basal insulin treatment equal to or more than 30 days prior to screening, compared to the dose at screening, dose adjustments of ± 25% are allowed) or
• stable dose of basal insulin

Exclusion criteria

• Diagnosis of type 1 diabetes
• Maturity onset diabetes of the young (MODY)
• Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

132 participants in 2 patient groups, including a placebo group

Semaglutide - max. tolerated dose

Experimental group

Description:

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.

Treatment:

Drug: Oral semaglutide

Placebo (semaglutide)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (semaglutide)