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Original Research
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
Julio Rosenstock, Christopher H. Sorli, Michael E. Trautmann, Cristóbal Morales, Ulrich Wendisch, George Dailey, Marcus Hompesch, In Young Choi, Jahoon Kang, John Stewart, Kun-Ho Yoon
Diabetes Care 2019 Jul; dc182648. https://doi.org/10.2337/dc18-2648
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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.

Footnotes

  • This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc18-2648/-/DC1.

  • Received December 28, 2018.
  • Accepted June 23, 2019.
  • © 2019 by the American Diabetes Association.
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Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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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
Julio Rosenstock, Christopher H. Sorli, Michael E. Trautmann, Cristóbal Morales, Ulrich Wendisch, George Dailey, Marcus Hompesch, In Young Choi, Jahoon Kang, John Stewart, Kun-Ho Yoon
Diabetes Care Jul 2019, dc182648; DOI: 10.2337/dc18-2648

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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
Julio Rosenstock, Christopher H. Sorli, Michael E. Trautmann, Cristóbal Morales, Ulrich Wendisch, George Dailey, Marcus Hompesch, In Young Choi, Jahoon Kang, John Stewart, Kun-Ho Yoon
Diabetes Care Jul 2019, dc182648; DOI: 10.2337/dc18-2648
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© 2021 by the American Diabetes Association. Diabetes Care Print ISSN: 0149-5992, Online ISSN: 1935-5548.