Type 2 diabetes is on the rise in children and teens, but treatment options for pediatric patients have remained more limited than those available to adults. In its first pediatric trial, a new drug — already used by type 2 diabetic adults — has proven effective for blood sugar control in children and teens with type 2 diabetes.
The results of this Yale-led trial are published in the New England Journal of Medicine.
William Tamborlane, M.D., first author and pediatric endocrinologist at Yale, said the success of the new drug, liraglutide, will be “transformational” for youth with type 2 diabetes. He explained that metformin and insulin are the only drugs currently approved for the treatment of children and teens with the condition.
Tamborlane and his co-authors note that, when taken alone, metformin — the most popular initial treatment for type 2 diabetic youth — often leads to an early loss of blood sugar control. In addition, add-on treatment with insulin usually fails to lower blood-sugar levels. This is why the researchers say they found it imperative to test another, and possibly better, treatment option in that population.
“As a result of this study, we anticipate that youth with type 2 diabetes will soon have a third option that has not previously been available,” said Tamborlane.
The year-long clinical trial focused on the effect of liraglutide on the blood sugar and glycated hemoglobin (or A1c) levels of a diverse, international sample of youth aged 10-16 with type 2 diabetes who were already taking metformin with or without insulin. For those with type 2 diabetes, 7% is the magic number for A1c levels; anything below that means the condition is relatively well-controlled. One half of the study group took metformin plus liraglutide and the other half took metformin plus a placebo. The researchers took the blood sugar and A1c levels of the participants after six-months and one year.
By six months, blood sugar was substantially lower in the liraglutide group than the placebo group, and the liraglutide group had A1c levels 1.06 percentage points lower than the placebo group. After one year, the liraglutide group had A1c levels 1.3 percentage points lower than the placebo group, which actually experienced an average 0.5 percentage point increase.
By the end of the trial, nearly two thirds of the liraglutide group had A1c levels under the 7% goal compared to just one third of the placebo group who met that target. Liraglutide also proved to be safe and have only minimal gastrointestinal side effects during the course of the trial.
Funding for this study was provided by Novo Nordisk, the drug company that has developed a brand-name form of liraglutide.
Other authors include Margarita Barrientos-Pérez, Udi Fainberg, Helle Frimer-Larsen, Mona Hafez, Paula M. Hale, Muhammad Y. Jalaludin, Margarita Kovarenko, Ingrid Libman, Jane L. Lynch, Paturi Rao, Naim Shehadeh, Serap Turan, Daniel Weghuber, and Timothy Barrett.