A prospective, investigator initiated, interventional, single arm, open-label study to evaluate the efficacy and safety of Imeglimin using Continuous Glucose Monitoring (CGM) in Type 2 Diabetes Mellitus (T2DM) patients

Type 2 diabetes mellitus (T2DM), the most common type of diabetes, is a chronic condition that occurs due to persistently high blood sugar (glucose) levels (hyperglycemia). Blood glucose obtained from food is the main source of energy and Insulin, (a hormone made by the beta cells of pancreas) helps glucose get into the fat, liver and muscle cells to be used for energy.

Imeglimin is a first-in-class novel oral antidiabetic drug used to treat T2DM targeting mitochondrial bioenergetics. It improves mitochondrial function by modulating mitochondrial respiratory chain complex activities while decreasing reactive oxygen species production. Imeglimin has been shown to amplify glucose-stimulated insulin secretion by improving β-cell glucose response in patients with T2DM and to improve insulin sensitivity in a rodent model of diabetes, allowing for normalization of glucose tolerance. More recent data suggest that imeglimin prevents the death of human endothelial cells by inhibiting opening of the mitochondrial permeability transition pore—a known cause of cell death—without inhibiting mitochondrial respiration this finding suggests the potential for end organ protection (e.g. kidney or heart)

The current study is an open-label, single-arm interventional trial initiated by the investigator to evaluate the efficacy and safety of Imeglyn® in patients with T2DM. Using CGM technology, the study will capture real-time data on glucose dynamics, such as postprandial spikes and hypoglycemic episodes. This approach aims to provide a deeper understanding of Imeglimin’s clinical benefits, offering insights beyond conventional glycemic measurements.