Short-Term Glycemic Outcomes Associated with Imeglimin Use Among Patients with Type 2 Diabetes Mellitus: A Prospective Observational Study.
Type 2 diabetes mellitus (T2DM) remains difficult to manage due to progressive β-cell dysfunction and poor glycaemic control, while imeglimin, a novel oral agent with multimodal metabolic effects, has shown promising clinical results but limited real-world evidence, particularly in Indian populations. This study compared short-term glycaemic and metabolic outcomes in adults with T2DM receiving imeglimin versus standard antidiabetic therapy in routine clinical care.
A non-randomized, prospective observational cohort study was conducted among adults with type 2 diabetes mellitus between January and August 2025, comparing imeglimin (n = 88) with standard antidiabetic therapy without imeglimin (n = 100). Clinical and laboratory parameters were assessed at baseline and 3 months, with HbA1c as the primary endpoint. Baseline balance was assessed using standardized mean differences (SMDs). Outcomes were analyzed using multivariable linear regression, ANCOVA, and logistic regression (p < 0.05).
A total of 188 adults with type 2 diabetes mellitus were included (Imeglimin: n = 88; Non-Imeglimin: n = 100), with comparable baseline characteristics. At 12 weeks, the Imeglimin group showed greater reductions in HbA1c, fasting plasma glucose, postprandial glucose, and mean blood glucose (all p ≤ 0.011), and a greater increase in HDL cholesterol (p = 0.003). A higher proportion achieved ≥0.5% HbA1c reduction (52.27% vs 38.00%; adjusted OR: 1.82; 95% CI: 1.01-3.27). In multivariable analysis, imeglimin use was independently associated with lower Week-12 HbA1c (β = -0.29; 95% CI: -0.44 to -0.14; p < 0.001).
Imeglimin use was associated with greater reductions in HbA1c and other glycaemic parameters over 12 weeks compared with non-imeglimin therapy and remained significantly associated with lower Week-12 HbA1c after adjustment for baseline and clinical covariates. Most metabolic parameters remained stable, with a modest improvement in HDL cholesterol observed. Further large-scale studies with longer follow-up are needed to confirm these findings.
A non-randomized, prospective observational cohort study was conducted among adults with type 2 diabetes mellitus between January and August 2025, comparing imeglimin (n = 88) with standard antidiabetic therapy without imeglimin (n = 100). Clinical and laboratory parameters were assessed at baseline and 3 months, with HbA1c as the primary endpoint. Baseline balance was assessed using standardized mean differences (SMDs). Outcomes were analyzed using multivariable linear regression, ANCOVA, and logistic regression (p < 0.05).
A total of 188 adults with type 2 diabetes mellitus were included (Imeglimin: n = 88; Non-Imeglimin: n = 100), with comparable baseline characteristics. At 12 weeks, the Imeglimin group showed greater reductions in HbA1c, fasting plasma glucose, postprandial glucose, and mean blood glucose (all p ≤ 0.011), and a greater increase in HDL cholesterol (p = 0.003). A higher proportion achieved ≥0.5% HbA1c reduction (52.27% vs 38.00%; adjusted OR: 1.82; 95% CI: 1.01-3.27). In multivariable analysis, imeglimin use was independently associated with lower Week-12 HbA1c (β = -0.29; 95% CI: -0.44 to -0.14; p < 0.001).
Imeglimin use was associated with greater reductions in HbA1c and other glycaemic parameters over 12 weeks compared with non-imeglimin therapy and remained significantly associated with lower Week-12 HbA1c after adjustment for baseline and clinical covariates. Most metabolic parameters remained stable, with a modest improvement in HDL cholesterol observed. Further large-scale studies with longer follow-up are needed to confirm these findings.
Authors
Kandasamy Kandasamy, Selvaraj Selvaraj, Orayj Orayj, Almanasef Almanasef, Asiri Asiri, Alshahrani Alshahrani, Alshulah Alshulah, Vasudevan Vasudevan, Alzaydani Alzaydani, Velmani Velmani
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