Restoring Insulin Secretion - Adult Medication Study

Approximately 10 percent of Americans have diabetes and at least 33 percent of American adults are considered prediabetic. The increasing loss of beta-cell function is one of the key factors in the pathogenesis of type 2 diabetes. Over time, increased insulin resistance and beta-cell dysfunction can lead to serious health complications in diabetics. Research efforts have begun to focus on the effects of certain interventions on insulin resistance and beta-cell function at the early stages of the disease. The Restoring Insulin Secretion (RISE) Adult Medication Study was established to determine if pharmaceutical treatment could preserve or improve beta-cell function in adults with prediabetes or recent onset type 2 diabetes.

The RISE Adult Medication Study was a partially double-blind, placebo-controlled, four-arm clinical trial. Study participants were randomized into four groups and received treatment for 12 months. During the treatment period, the first group received Metformin alone; the second group received Glargine for three months, followed by Metformin for the remaining nine months; the third group received Liraglutide in combination with Metformin; and the fourth group was treated with placebo. Following the 12-month treatment period, each group underwent treatment withdrawal for three months. Insulin sensitivity and beta-cell function was evaluated at baseline, the end of the treatment period, and the end of the withdrawal period.