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Factors contributing to the clinical effectiveness of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus.

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  • Additional Information
    • Source:
      Publisher: Asian Association for the Study of Diabetes and Blackwell Pub. Asia Country of Publication: Japan NLM ID: 101520702 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2040-1124 (Electronic) Linking ISSN: 20401116 NLM ISO Abbreviation: J Diabetes Investig Subsets: MEDLINE
    • Publication Information:
      Original Publication: Tokyo : Asian Association for the Study of Diabetes and Blackwell Pub. Asia
    • Subject Terms:
      Diabetes Mellitus, Type 2*/drug therapy ; Diabetes Mellitus, Type 2*/blood ; Glycated Hemoglobin*/analysis ; Hypoglycemic Agents*/therapeutic use ; Triazines*/therapeutic use; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Blood Glucose/analysis ; Double-Blind Method ; East Asian People ; Japan ; Treatment Outcome
    • Abstract:
      Aims/introduction: To investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.
      Materials and Methods: Data were pooled from two randomized, placebo-controlled, 24-week, double-blind studies of imeglimin monotherapy in Japanese adults with type 2 diabetes mellitus, with the proportion of responders (glycated hemoglobin [HbA1c] < 7.0%) and sustained responders (i.e., achieved and maintained response) in the imeglimin 1,000 mg twice daily group calculated at each visit. Patient factors significantly (P < 0.05) correlated with response were explored through multivariate logistic regression. Subgroup analyses compared the efficacy of imeglimin in patients with a HbA1c improvement less than or equal to -0.3% (early responders) versus greater than -0.3% (early non-responders) at week 4.
      Results: A total of 38.0% of imeglimin-treated patients and 7.2% of placebo-treated patients were responders (P < 0.001, number needed to treat = 4). The proportion of sustained responders at weeks 4, 8, 12, 16 and 20 was 10.6, 19.0, 24.0, 25.7 and 29.1%, respectively (>70% of responders at each visit). Improvements in HbA1c and fasting glucose were significantly greater in early responders versus early non-responders from week 4; between-group differences remained significant to week 24. Older age (odds ratio 1.09, 95% confidence interval 1.04-1.14; P < 0.001); treatment-naïve status vs previous treatment (odds ratio 3.70, 95% confidence interval 1.55-8.82; P = 0.003), and lower baseline HbA1c (odds ratio 0.06, 95% confidence interval 0.02-0.16; P < 0.001) predicted response.
      Conclusions: A significantly higher proportion of patients receiving imeglimin 1,000 mg twice daily monotherapy were responders versus placebo. Most (>70%) were sustained responders, suggesting that response is fairly predictable. Older age, treatment-naïve status and early treatment response significantly predicted imeglimin effectiveness.
      (© 2024 The Author(s). Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.)
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    • Grant Information:
      Sumitomo Pharma Co. Ltd.
    • Contributed Indexing:
      Keywords: Imeglimin; Treatment response; Type 2 diabetes mellitus
    • Accession Number:
      0 (Blood Glucose)
      0 (Glycated Hemoglobin)
      0 (hemoglobin A1c protein, human)
      0 (Hypoglycemic Agents)
      UU226QGU97 (imeglimin)
      0 (Triazines)
    • Publication Date:
      Date Created: 20240525 Date Completed: 20240830 Latest Revision: 20241009
    • Publication Date:
      20250114
    • Accession Number:
      PMC11363113
    • Accession Number:
      10.1111/jdi.14247
    • Accession Number:
      38794986