Efficacy and safety of efpeglenatide in key patient subgroups from the BALANCE randomized trial, stratified by pre-diabetes status, BMI, and age at baseline.

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  • Additional Information
    • Source:
      Publisher: Published by BMJ in partnership with the American Diabetes Association Country of Publication: England NLM ID: 101641391 Publication Model: Print Cited Medium: Internet ISSN: 2052-4897 (Electronic) Linking ISSN: 20524897 NLM ISO Abbreviation: BMJ Open Diabetes Res Care Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : Published by BMJ in partnership with the American Diabetes Association
    • Subject Terms:
      Diabetes Mellitus, Type 2*/drug therapy ; Prediabetic State*/drug therapy; Body Mass Index ; Humans ; Hypoglycemic Agents/adverse effects ; Proline
    • Abstract:
      Introduction: Efpeglenatide is a long-acting glucagon-like peptide-1 receptor agonist being developed to improve glycemic control in type 2 diabetes (T2D). In the BALANCE 205 study (NCT02075281), efpeglenatide significantly reduced body weight versus placebo in patients with obesity, or overweight with comorbidities, and without T2D. These subanalyses explore the efficacy and safety of efpeglenatide in subgroups of patients with pre-diabetes and stratified by body mass index (BMI) or age from the BALANCE study.
      Research Design and Methods: The 20-week BALANCE study randomized patients with BMI ≥30 kg/m 2 or ≥27 kg/m 2 with comorbidities, and without diabetes, to efpeglenatide 4 mg or 6 mg once weekly, 6 mg or 8 mg once every 2 weeks, or placebo. For these subanalyses, patients were stratified by pre-diabetes status (glycated hemoglobin (HbA 1c ) 5.7%-6.4% (39-46 mmol/mol) or fasting plasma glucose (FPG) 100-125 mg/dL) and by BMI or age < or ≥ median values (34.9 kg/m 2 and 44 years, respectively) at baseline.
      Results: In patients with pre-diabetes at baseline, all efpeglenatide doses led to greater proportions of patients reverting to normoglycemia (40.6%-64.3%) versus placebo (10.0%), and greater reductions in HbA 1c (0.30%-0.38%), FPG (7.7-14.1 mg/dL), and weight (5.6-7.3 kg) versus placebo (nominal p<0.05 for all). In patients with BMI or age < or ≥ median, greater reductions in weight were observed with all efpeglenatide doses versus placebo (nominal p<0.01 for all). The most common adverse events in patients receiving efpeglenatide across patient subgroups were gastrointestinal adverse events.
      Conclusions: These results are consistent with the overall BALANCE population and suggest beneficial effects of efpeglenatide on glycemic control and body weight regardless of pre-diabetes status, age, or BMI at baseline. The effects of efpeglenatide on glycemic control in patients with pre-diabetes suggest it might help reduce the likelihood of at-risk patients developing diabetes.
      Competing Interests: Competing interests: REP has served as a consultant for AstraZeneca, Glytec, Janssen Pharmaceuticals, Merck, MundiPharma, Novo Nordisk, Pfizer, Sanofi, Sanofi US Services, Scohia Pharma, and Sun Pharmaceutical Industries; has received grants and research support from Hanmi Pharmaceutical, Janssen Pharmaceuticals, Metavention, Novo Nordisk, Poxel SA, and Sanofi; and has received honoraria from Novo Nordisk; honoraria and fees for these activities were directed to a non-profit organization with the exception of those from Sanofi US Services, which were personal fees. SB is an employee of Hanmi Pharmaceutical. MET is a consultant of ProSciento; has received consulting fees from Atrogi, CeQur SA, Hanmi Pharmaceutical, Kinexum, Novo Nordisk, and Servier; and is on the Data Monitoring Board for Profil. MH is an employee and shareholder of ProSciento and has received grants from Hanmi Pharmaceutical. OH is an employee of Hanmi Pharmaceutical. JS is an employee and shareholder of Sanofi. AS was an employee of Sanofi during the development of this publication. CHS was an employee and shareholder of Sanofi during the development of this publication. SJ has received personal fees from AstraZeneca, Boehringer Ingelheim, Lilly, MSD, Novo Nordisk, and Sanofi. K-HY has nothing to declare.
      (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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    • Contributed Indexing:
      Keywords: body mass index; glucagon-like peptide 1; glycated hemoglobin A; weight loss
    • Accession Number:
      0 (Hypoglycemic Agents)
      3M1V5Z2270 (efpeglenatide)
      9DLQ4CIU6V (Proline)
    • Publication Date:
      Date Created: 20220119 Date Completed: 20220323 Latest Revision: 20220716
    • Publication Date:
      20221213
    • Accession Number:
      PMC8768911
    • Accession Number:
      10.1136/bmjdrc-2021-002207
    • Accession Number:
      35042751