Join a Trial Testing Oral Semaglutide in Preteens and Teens with Type 2 Diabetes
If you are living with type 2 diabetes and are between 10-18 years old, you may be eligible to join a trial studying the impact of semaglutide on A1C and fasting glucose levels.
Clinical Trials Identifier: NCT04596631
Trial Name: A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes (PIONEER TEENS)
Diabetes Type: Type 2 diabetes
Trial Sponsor: Novo Nordisk
What is the aim of the study?
This study will investigate how safe and effective an oral version of semaglutide is in preteens and teens with type 2 diabetes.
Semaglutide is FDA approved for diabetes management, weight management, or to reduce cardiovascular events in adults with type 2 diabetes. Currently, the only form and dosage level of semaglutide – a weekly 2.4 mg injection of Wegovy – has been approved for use in pediatric patients, but they must be aged 12-17 and have a body mass index in the 95th percentile or greater to qualify.
If the data from this clinical trial is able to demonstrate that oral semaglutide is safe and effective, then oral semaglutide may also receive FDA approval for use among a younger population with type 2 diabetes.
How does the trial work?
For this study, researchers will observe approximately 132 participants with type 2 diabetes who are between the ages of 10 and 17.
Participants will be randomly chosen to receive either once-daily oral semaglutide (with dose escalation to an individual maximum tolerated dose) or a placebo. Each morning, participants will take a tablet on an empty stomach, waiting 30 minutes before eating, drinking, or taking other medication by mouth.
Researchers will be observing various outcome measures throughout the process; those include A1C levels, fasting blood glucose, BMI, waist circumference, body weight change, and blood pressure, among other measurements. Throughout the trial, subjects will have 12 clinic visits and 8 phone calls with a study doctor. At all 12 clinic visits, participants will have blood samples taken. Participants will also be asked some questions. In total, the study will last about 1 year and 3 months.
Are you interested in participating?
You may be eligible if you:
- Are anywhere from 10 to below 18 years of age at the day of randomisation
- Are able to provide informed consent from both the participant and the parental or legally acceptable representative for trial-related activities, including any procedures that are carried out as part of the trial as well as activities to determine suitability for the trial.
- Have an A1C of 6.5-11.0 (47-97 mmol/mol), both inclusive
- Have either been 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
People who have received a diagnosis of type 1 diabetes, maturity onset diabetes of the young (MODY), or have tested positive for insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies are not eligible to participate. See a full list of inclusion and exclusion criteria here.
This study is currently recruiting in California, Florida, Georgia, Indiana, Kentucky, Maryland, New York, Pennsylvania, Tennessee, Texas, Virginia, Australia, Austria, Czechia, Greece, India, Lebanon, Israel, Malaysia, Mexico, Morocco, the Netherlands, New Zealand, North Macedonia, Portugal, Puerto Rico, Romania, and the United Kingdom. To enroll or learn more about this study, contact the Novo Nordisk clinical trials team at [email protected] or call 1-866-867-7178.
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