Affiliation:
1. Medical Science, Sumitomo Pharma Co., Ltd. Tokyo Japan
2. Data Science, Sumitomo Pharma Co., Ltd. Tokyo Japan
3. Department of Metabolism and Endocrinology Juntendo University Graduate School of Medicine Tokyo Japan
4. Department of Medicine Kawasaki Medical School Okayama Japan
5. Department of Diabetes, Endocrinology and Metabolism National Center for Global Health and Medicine Tokyo Japan
Abstract
AbstractAims/IntroductionTo investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.Materials and MethodsData 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.ResultsA 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.ConclusionsA 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.