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

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

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.

It had two arms (groups): one (experimental) and Placebo (semaglutide) (placebo comparator).

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.

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 132 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, aged 10 to below 18 years at the day of randomisation. Diagnosed with type 2 diabetes mellitus according to the American Diabetes Association criteria and treated with:.

The full record lists 7 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-11-02 with completion listed for 2025-04-29.

It ran at 97 sites in United States (23), Greece (15), India (9), Russia (7), Ukraine (7) and Australia (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline (Week 0) to Week 26 in Glycosylated Haemoglobin (HbA1c)- Percentage Point (time frame: Baseline (Week 0), Week 26). Change From Baseline (Week 0) in HbA1c to Week 26- Millimoles Per Mole (mmol/Mol) (time frame: Baseline (Week 0), Week 26).

It also tracked 49 secondary outcomes, for example Change From Baseline (Week 0) in Fasting Plasma Glucose (FPG) to Week 26, Change From Baseline (Week 0) in Body Mass Index (BMI) Standard Deviation Score (SDS) to Week 26, Change From Baseline in HbA1c at Week 52 (Percentage Point), Change From Baseline in HbA1c at Week 52 (mmol/Mol), Change From Baseline in Fasting Plasma Glucose at Week 52 (mg/dL) and Change From Baseline in Body Weight to Week 26 and Week 52 (Kilograms [kg]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 132 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.