Efpeglenatide significantly lowers blood sugar and body weight in type 2 diabetes: AMPLITUDE-M trial

Korea: Monotherapy with once-weekly efpeglenatide signiifcanly improved blood sugar control and body weight in patients with type 2 diabetes managed with diet and exercise alone, a recent study in Diabetes Care has revealed. Its safety and tolerability was found to be similar to that of other glucagon-like peptide 1 receptor agonists (GLP-1 RAs) with a low risk of hypoglycemia. 

Owing to their glycemic efficacy, low risk of hypoglycemia, and favorable effects on body weight, GLP-1 RAs are currently recommended as the first injectable agent for patients with type 2 diabetes inadequately controlled on oral glucose-lowering medications. Seungjae Baek, Hanmi Pharmaceutical Co., Ltd, Seoul, Korea, and colleagues aimed to assess the safety and efficacy of the glucagon-like peptide 1 receptor agonist (GLP-1 RA) efpeglenatide versus placebo in patients with type 2 diabetes inadequately controlled with diet and exercise alone in AMPLITUDE-M trial -- a phase 3, double-blind, placebo-controlled, multicenter trial.

In the trial, adults with type 2 diabetes suboptimally controlled with diet and exercise alone were randomized to once-weekly efpeglenatide (2, 4, or 6 mg) or placebo for up to 56 weeks. The main objective was to demonstrate the superiority of efpeglenatide versus placebo for HbA1c reduction at week 30. Secondary objectives included changes in other measures of glycemic control and body weight at weeks 30 and 56.