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Imeglimin is a first-in-class oral antidiabetic agent that improves glycemia through dual actions on insulin secretion and sensitivity. However, real-world data on its long-term metabolic effects, particularly on endogenous insulin secretion, remain limited. We aimed to evaluate 12-month longitudinal changes in glycemic indices, an insulin secretion index, and treatment intensity during imeglimin therapy in routine clinical practice.

This retrospective observational study included 73 Japanese patients with type 2 diabetes mellitus who continued imeglimin therapy for approximately 12 months. Hemoglobin A1c (HbA1c) and glycated albumin (GA) were assessed at baseline and follow-up. Fasting plasma glucose and C-peptide levels obtained between 10 and 14 months after initiation were used to calculate the fasting C-peptide index (fCPI). Overall glucose-lowering treatment intensity was quantified using the medication effect score (MES).

HbA1c significantly decreased from 8.55% ± 1.38% to 7.67% ± 0.99% over 12 months (p < 0.0001). GA also declined from the early phase after initiation, whereas the GA/HbA1c ratio showed only transient change without sustained differences. The fCPI increased from 1.14 [0.65-1.84] to 1.21 [0.79-2.01] (n = 69, p = 0.003), and an early increase was observed within 1-2 months. Despite frequent adjustments to background therapies, treatment intensity as assessed by MES did not change significantly.

In a real-world setting, long-term imeglimin therapy was associated with sustained glycemic improvement and early as well as sustained numerical changes in an insulin secretion index without an increase in overall treatment intensity.