Efficacy and safety of once-monthly efpeglenatide in patients with type 2 diabetes: Results of a phase 2 placebo-controlled, 16-week randomized dose-finding study
Diabetes, Obesity and Metabolism Mar 12, 2020
Del Prato S, Kang J, Trautmann ME, et al. - In patients with type 2 diabetes inadequately controlled on metformin, researchers determined the optimal dose(s) of once-monthly (QM) administration of efpeglenatide (formerly HM11260C), a long-acting glucagon-like peptide-1 receptor agonist (GLP-1 RA). Study participants were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg QM; n = 158) or placebo (n = 51). The 16-week treatment period involved a 4-week titration phase with once-weekly (QW) efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg QM and two doses of the assigned QM dose. All efpeglenatide doses significantly lessened HbA1c compared with placebo. Overall, the least squares mean difference in HbA1c decreases between efpeglenatide and placebo was ˗0.71%. A significantly greater proportion of efpeglenatide patients had HbA1c < 7% (< 53 mmol/mol) vs placebo (48.7% vs 30.6%) at Week 17. According to this phase 2, randomized, placebo-controlled, double-blind trial, in patients with type 2 diabetes, efpeglenatide QM (following QW titration) has significant benefits on HbA1c and weight reduction vs placebo.
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