The aim of this meta-analysis is to evaluate the role of Imeglimin in glycemic control (HbA1c & FPG), Homeostatic Model Assessment of β-cell function, pro-insulin to c-peptide ratio and its safety outcomes in patients with type 2 diabetes mellitus.

A thorough literature search was performed on PubMed Central, PubMed, Cochrane, Wiley online library databases and efficacy outcomes such as changes in HbA1c, FPG, pro-insulin to c-peptide ratio and HOMA- β were summarized as standardized mean difference and safety outcomes were summarized as odds ratio. (PROSPERO registration no. CRD42023422787).

Seven randomized controlled trials conducted on 1,454 patients with type 2 diabetes mellitus were included. Overall the random effects model meta-analysis of standardized mean difference demonstrated that Imeglimin was significantly associated with HbA1c reduction of -0.85% (95% CI -1.08 to -0.62, p<0.00001) with heterogeneity (i² = 70%, p = 0.002), fasting plasma glucose (FPG) reduction of -0.64 mmol/L (95% CI -0.81 to -0.47, p<0.00001) with non-significant low heterogeneity (i² = 35%, p = 0.16) and significantly improved HOMA-β function by 0.46 (95% CI 0.25 to 0.67, p<0.0001) compared to control groups with non-significant heterogeneity (i² = 4%, p = 0.31). Further, the overall analysis of gastrointestinal (GI) adverse events demonstrated that Imeglimin was significantly associated with GI events (OR, 1.83; 95% CI, 1.19 to 2.82; p = 0.006) with no heterogeneity (i² = 0%, p = 0.80).

Our results demonstrated that Imeglimin is significantly associated with the glycemic control (reduction of HbA1c by -0.85% & FPG by -0.64 mmol/L), improved beta cell function (HOMA-β by 0.46) and associated with GI adverse events by 1.83 fold increased odds as compared to controls.