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Imeglimin demonstrated sustained glycemic effectiveness and consistent tolerability across age groups in routine clinical practice. In a real-world retrospective study published in Frontiers in Clinical Diabetes and Healthcare, imeglimin use was associated with sustained HbA1c reduction over 12 months in adults with T2DM.

The analysis included 79 adults with T2DM who newly initiated imeglimin at a dose of 1,000 mg twice daily and were followed for 12 months at a single center in Japan. Participants were stratified by age (<65 years, 65-74 years, and ≥75 years) and by the presence or absence of biguanide dose reduction at imeglimin initiation. The primary outcome was change in HbA1c from baseline to 12 months. Secondary outcomes included glycemic target achievement, adverse events, and changes in metabolic parameters.

HbA1c declined significantly within 1 month of imeglimin initiation and remained improved through 12 months, with a mean change of −0.8 ± 1.2%. Glycemic response and safety outcomes did not differ significantly across age categories. Gastrointestinal symptoms were the most common adverse events, occurring in 21.5% of individuals, with no age-related differences.

HbA1c reduction was greater in individuals without biguanide dose reduction compared with those with dose reduction (−1.5 ± 1.7% vs −0.5 ± 0.7%; P = 0.019). Gastrointestinal adverse events occurred more frequently when imeglimin was combined with metformin doses of at least 1,000 mg/day (P = 0.032). Significant reductions in body weight, triglycerides, and liver enzymes were also observed at 12 months.

These findings indicate that imeglimin provides sustained glycemic benefit with favorable tolerability in real-world care, including among older adults with T2DM. Combination strategies may influence gastrointestinal tolerability, particularly at higher metformin doses.

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Key highlights
  • Type 2 diabetes mellitus (T2DM) treated with imeglimin showed sustained glycated hemoglobin reduction over 12 months (mean change −0.8 ± 1.2%).
  • Glycemic effectiveness and adverse event rates were similar across age groups, including adults aged ≥75 years.
  • Gastrointestinal adverse events were more frequent when imeglimin was combined with metformin ≥1,000 mg/day.
Source

Fujisawa T, Kato T, Takami K, et al. Real-world effectiveness and safety of imeglimin: a single-center retrospective cohort study in Japan. Front Clin Diabetes Healthc. Published December 16, 2025. doi:10.3389/fcdhc.2025.1694522

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Imeglimin Maintains Glycemic Control With Stable Safety Profile in Older Adults With T2DM
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A retrospective study evaluates long-term glycemic effectiveness, safety, and combination considerations for imeglimin in routine care
 

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