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 & Metabolism
Stefano Del PratoKun-Ho Yoon

Abstract

To determine the optimal dose(s) of once-monthly administration of efpeglenatide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D) inadequately controlled on metformin. In this phase 2, randomized, placebo-controlled, double-blind trial (NCT02081118), patients were randomized 1:1:1:1 to subcutaneous efpeglenatide (8, 12 or 16 mg once monthly; n = 158) or placebo (n = 51). The 16-week treatment period 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. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to week 17. All efpeglenatide doses significantly reduced HbA1c versus placebo (P < 0.0001 for all). Overall, the least squares mean difference in HbA1c reductions between efpeglenatide and placebo was -7.7 mmol/mol (-0.71%; baseline to week 17). At week 17, a significantly greater proportion of efpeglenatide patients had an HbA1c level <53 mmol/mol (<7%) versus placebo (48.7% vs. 30.6%; P = 0.0320). Significant body weight loss occurred across all efpeglenatide doses (placebo-corrected reduction -2.0 kg [efpeglenatide overall]...Continue Reading

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Citations

Jul 11, 2020·Expert Opinion on Drug Discovery·Karl Sebastian JohanssonMikkel Bring Christensen
Mar 17, 2020·Diabetes, Obesity & Metabolism·Kun-Ho YoonChristopher H Sorli
Mar 9, 2021·Endocrinology and Metabolism·Hun Jee Choe, Young Min Cho
Jul 8, 2021·Expert Review of Clinical Pharmacology·Dhiren Patel, April Smith

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Clinical Trials Mentioned

NCT02057172
NCT01452451
NCT02081118

Software Mentioned

AMPLITUDE
ProSciento

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