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- Title
Effect of patient characteristics on the efficacy and safety of imeglimin monotherapy in Japanese patients with type 2 diabetes mellitus: A post‐hoc analysis of two randomized, placebo‐controlled trials.
- Authors
Hagi, Katsuhiko; Kochi, Kenji; Watada, Hirotaka; Kaku, Kohei; Ueki, Kohjiro
- Abstract
Aims/Introduction: Substantial variability in demographic and clinical characteristics exists among patients with type 2 diabetes mellitus, which may impact treatment. This post‐hoc analysis evaluated the efficacy and safety of imeglimin 1,000 mg twice daily (BID) monotherapy in type 2 diabetes mellitus patients according to demographic and clinical characteristics. Materials and Methods: Data were pooled from two placebo‐controlled, 24 week, randomized, double‐blind studies in adults with type 2 diabetes mellitus. Outcomes (least squares mean [LSM] change in HbA1c from baseline to week 24, and safety) were analyzed according to subgroups based on demographics, clinical characteristics, and comorbidities. Results: The difference in LSM change in HbA1c from baseline to week 24 was statistically significant for imeglimin vs placebo in all patient subgroups analyzed (P < 0.05 each), including demographics (age, body mass index), clinical characteristics (duration of type 2 diabetes mellitus, chronic kidney disease [CKD] stage, and prior medication use) and comorbidities (hypertension, dyslipidemia, risk of hepatic fibrosis and liver function parameter status). A statistically significant separation from placebo in HbA1c was observed at week 4 and maintained through week 24. No new safety concerns were identified with imeglimin in any patient subpopulations. Conclusions: The efficacy and safety of imeglimin was demonstrated across patient subgroups, irrespective of baseline demographic and clinical characteristics. Our findings confirm the efficacy and safety of imeglimin across a broad spectrum of patients with type 2 diabetes mellitus.
- Subjects
TYPE 2 diabetes; JAPANESE people; DYSLIPIDEMIA; FIBROSIS; HEPATIC fibrosis; CHRONIC kidney failure; BODY mass index; ORAL medication; LIVER histology
- Publication
Journal of Diabetes Investigation, 2023, Vol 14, Issue 9, p1101
- ISSN
2040-1116
- Publication type
Article
- DOI
10.1111/jdi.14035