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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT04596631

Run by

Novo Nordisk A/S

People needed

132

Starts

2020-11-02

Expected to finish

2026-02-03

Last updated by the study team

2026-03-11

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Children's Hospital Los Angeles - Endocrinology — Los Angeles, California, United States
• Yale School Of Medicine — New Haven, Connecticut, United States
• Nemours Chld Clnc Jacksonville — Jacksonville, Florida, United States
• Nemours Children's Health — Pensacola, Florida, United States
• University of South Florida Diabetes Center — Tampa, Florida, United States
• Children's Healthcare Atlanta — Atlanta, Georgia, United States
• Columbus Research Foundation — Columbus, Georgia, United States
• Indiana Uni School of Med-Ped — Indianapolis, Indiana, United States
• University Of Louisville Research Foundation — Louisville, Kentucky, United States
• Pennington Biomed Res Ctr — Baton Rouge, Louisiana, United States
• Barry J. Reiner, MD LLC — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• UBMD Peds-Div of Endo/Diabetes — Buffalo, New York, United States
• UPMC Child Hosp-Pittsburgh — Pittsburgh, Pennsylvania, United States
• Monument Health Clinical Rsrch — Rapid City, South Dakota, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Tech University HSC — Amarillo, Texas, United States
• Univ Of Texas Hlth Science Cntr — San Antonio, Texas, United States
• NE Clin Res of San Antonio — San Antonio, Texas, United States
• Pediatric Endo UVHS — Charlottesville, Virginia, United States
• Virginia Commonwealth University_Richmond — Richmond, Virginia, United States
• Virginia Commonwealth Univ — Richmond, Virginia, United States
• Gosford Hospital — Gosford, New South Wales, Australia
• Westmead Children's Hospital- The Clinical Research Centre — Westmead, New South Wales, Australia
• UAB Ped Endo Children's Hosp — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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