Safety and Efficacy of Imeglimin for Type 2 Diabetes in Patients Undergoing Dialysis

Abstract

Background/Aim: Imeglimin is a novel small molecular tetrahydrotriazine that has been shown to improve hyperglycemia in clinical trials among patients with type 2 diabetes. Nevertheless, its pharmacokinetics in patients with renal dysfunction remain unclear. The objective of this study was to elucidate the safety and effects of imeglimin in patients with type 2 diabetes undergoing dialysis. Patients and Methods: Six patients with type 2 diabetes undergoing hemodialysis (HD) or peritoneal dialysis (PD) received imeglimin 500 mg/day. The observation period was 3.3±2.3 months. Results: Fasting blood glucose was significantly decreased, compared to baseline after imeglimin treatment (126.2±32.0 mg/dl, p=0.037, vs. baseline). Furthermore, levels of alanine aminotransferase were decreased (10.3±6.3 IU/l, p=0.006, vs. baseline). Glycated hemoglobin A1c and triglyceride tended to be decreased, albeit without statistical significance. Levels of total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, and aspartate aminotransferase were not changed compared to baseline values. Conclusion: Despite the small sample size, imeglimin was found to be an effective and relatively well-tolerated agent for the treatment of patients with type 2 diabetes undergoing both HD and PD. During the observation period, adverse events such as hypoglycemia, diarrhea, nausea, or vomiting were not recognized in any patient.