Study Explores Dose Ranges for Efpeglenatide in Early T2DM

Efpeglenatide once weekly leads to dose-dependent reductions in glucose and body weight in patients with early type 2 diabetes, according to a phase 2 study published online in Diabetes Care.

Julio Rosenstock, M.D., from the Dallas Diabetes Research Center at Medical City, and colleagues evaluated the safety and efficacy of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (drug naive or on metformin monotherapy [90 percent]). Among the participants, 181 were randomly assigned to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.), 37 received a placebo, and 36 received liraglutide (≤1.8 mg daily).

The researchers found that during the 12-week study period, all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo to a final HbA1c of 6.3 to 6.8 percent versus 7.7 to 8 percent at baseline. Masked efpeglenatide 4 mg was noninferior to open-label liraglutide. Compared with placebo, greater proportions treated with efpeglenatide ≥1 mg achieved HbA1c <7 percent (61 to 72 percent versus 24 percent). There were also greater reductions in body weight with efpeglenatide 3 and 4 mg versus placebo. After the initial two weeks, reports of nausea and vomiting subsided.

"Efpeglenatide once weekly led to significant reductions in HbA1c and weight, with a safety profile consistent with the GLP-1 RA class in patients with early type 2 diabetes mostly on metformin monotherapy," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Sanofi, which manufactures efpeglenatide and funded the study.

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