The First Trial to Test GLP-1 Agonists in Adolescents

By Ben Pallant

A new trial will test if the once-weekly injectable, Bydureon, is also safe and effective in adolescents.

Clinical Trials Identifier: NCT01554618

Trial Name: Safety and Efficacy Study of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Diabetes Type: Type 2 diabetes

What it’s testing: This trial is testing how effective Bydureon (exenatide), AstraZeneca’s once-weekly injectable, is for adolescents with type 2 diabetes between 10 and 18 years old. Exenatide is a GLP-1 agonist, approved for adults with type 2 diabetes in a once-weekly injectable form (Bydureon) and as a twice-daily injectable (Byetta).

What it’s measuring: The study’s will measure A1c and any side effects from the medication. Secondary outcomes will include weight, blood pressure, fasting plasma glucose (FPG), blood pressure, and lipids (cholesterol, triglycerides).

Why is this new/important: GLP-1 agonists, which offer the dual benefits of A1c reduction and weight loss, are an increasingly popular class of type 2 diabetes drugs. Approved GLP-1s include Bydureon, Byetta, Lyxumia/Adlyxin, Ozempic, Tanzeum, Trulicity, and Victoza. There are also two approved combination basal insulin/GLP-1 agonists: Soliqua and Xultophy. None of these drugs, however, has been specifically studied and approved for people under the age of 18. This is the first trial to see whether exenatide is effective and safe for adolescents.

The number of children and teenagers with type 2 diabetes has increased. Some research suggests that people diagnosed with type 2 as adolescents have high rates of complications, perhaps partly because the medical system is not as well prepared for managing type 2 diabetes in this age group. The only drugs approved for adolescents are insulins and metformin; increasing the number of drugs that are available and safe for teens may help them more easily and successfully manage their type 2 diabetes.

Trial Length: 1 year

Trial Locations: The trial is currently recruiting at 45 locations, including in sixteen US states and locations in Bulgaria, Hungary, Israel, Kuwait, Mexico, and Ukraine.

Do you qualify?

• At least 10 years old and not yet 18 years old at the start of the trial

• Diagnosed type 2 diabetes

• A1c of 6.5% to 11.0% for those not taking insulin or sulfonylureas, or of 6.5% to 12.0% for those who are taking insulin and/or sulfonylureas

• Treated with diet and exercise alone or in combination with an oral (pill) diabetes drug and/or insulin for their type 2 diabetes for at least 2 months 

• Fasting plasma glucose concentration less than 280 mg/dl at the start of the trial

Exclusion criteria include:

• Clinically significant medical condition that could potentially affect study participation and/or personal well-being

• Pregnancy

• Previous use of exenatide or another GLP-1 agonist.

For a full list of the trial’s inclusion criteria, please visit its webpage here.

Where to get more information: For more information about the trial, you can contact the AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com).