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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 Apr 10, 2020

Del Prato S, Kang J, Trautmann ME, et al. - Researchers conducted this phase 2, randomized, placebo‐controlled, double‐blind trial to assess the optimal dose(s) of once‐monthly administration of efpeglenatide, a long‐acting glucagon‐like peptide‐1 receptor agonist (GLP‐1RA), in T2D patients inadequately controlled on metformin. Study participants were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51). The treatment period of 16 weeks included a 4-week titration phase with once‐weekly efpeglenatide 4 mg, followed by one dose of efpeglenatide 8 mg once monthly and two doses of the assigned once‐monthly dose. According to results, all doses of efpeglenatide significantly decreased HbA1c compared with placebo. Overall, −7.7 mmol/mol was the least squares mean difference in reduction of HbA1c between efpeglenatide and placebo. Efpeglenatide once monthly (following once‐weekly titration) has significant advantages with respect to HbA1c and weight reduction compared with placebo in T2D patients.

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