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Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.

Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.

Author information

1
Dallas Diabetes Research Center at Medical City, Dallas, TX juliorosenstock@dallasdiabetes.com.
2
Sanofi, Bridgewater, NJ.
3
ProSciento, Chula Vista, CA.
4
Day Hospital & Diabetes Research Unit, Clinical Management Unit Endocrinology and Nutrition, Virgen Macarena University Hospital, Seville, Spain.
5
Group Practice in Internal Medicine and Diabetology, Hamburg, Germany.
6
Scripps Clinic, John R. Anderson V Medical Pavilion, La Jolla, CA.
7
Hanmi Pharmaceutical Co., Ltd., Seoul, South Korea.
8
Sanofi Canada, Laval, Quebec, Canada.
9
The Catholic University of Korea, Seoul, South Korea.

Abstract

OBJECTIVE:

To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy).

RESEARCH DESIGN AND METHODS:

EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36). The primary efficacy end point was change in HbA1c from baseline to week 13.

RESULTS:

From a baseline HbA1c of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%, P < 0.05 for all) to a final HbA1c of 6.3-6.8% (45.4-50.6 mmol/mol); masked efpeglenatide 4 mg was noninferior to open-label liraglutide. Greater proportions treated with efpeglenatide ≥1 mg than placebo achieved HbA1c <7% (61-72% vs. 24%, P < 0.05 for all), and greater reductions in body weight were observed with efpeglenatide 3 and 4 mg versus placebo (placebo-adjusted LS mean differences -1.4 and -2.0 kg, respectively, P < 0.05 for both). Rates of nausea and vomiting were consistent with other GLP-1 RAs and rapidly subsided after the initial 2 weeks. No neutralizing antibodies were detected with efpeglenatide.

CONCLUSIONS:

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 T2D mostly on metformin monotherapy.

PMID:
31320446
DOI:
10.2337/dc18-2648

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