Restoring Insulin Secretion – Pediatric Medication Study

Although type 2 diabetes is more common in adults, there has been an increase in the number of children with the disease, primarily due to the obesity epidemic. As with adults, the decline of beta-cell function and insulin sensitivity are precursors of type 2 diabetes in children. There are several treatments for adults with type 2 diabetes, however insulin and metformin are the only approved treatments for children with type 2 diabetes. The purpose of the Restoring Insulin Secretion (RISE) Pediatric Medication Study was to determine whether metformin or insulin combined with metformin could be used to sustain or improve beta-cell function in children with prediabetes or recently diagnosed type 2 diabetes.

The RISE Pediatric Medication Study was a two-arm, multi-center clinical trial. Study participants were enrolled at four recruitment centers and randomized into two treatment groups. The first group received metformin alone for 12 months. The second group received glargine, a man-made insulin, for three months followed by metformin for the remaining nine months of the treatment period. Beta-cell function and insulin sensitivity were assessed at baseline, the end of the active treatment period, and three months after treatment was withdrawn.