Phase 2 clinical trial evaluating the safety and efficacy of imeglimin added to metformin therapy in patients with type 2 diabetes mellitus

This study is a phase 2 clinical trial that tested the safety and efficacy of the oral anti-diabetic drug (OAD) imeglimin in combination with metformin for patients with type 2 diabetes mellitus (T2DM). The results showed that the addition of imeglimin to metformin therapy improved the blood sugar (glucose) control in these patients. Also, the combination therapy was determined to be as safe as treatment with metformin alone.

Initial treatment for T2DM usually involves lifestyle changes and metformin. When these methods do not work, doctors will often add insulin injections or other OAD. Studies suggest that combining various OAD that act in different ways may be the key to best controlling glucose levels in patients with T2DM. Imeglimin is a newly developed OAD that has been shown to be as effective as metformin in controlling blood glucose levels.

This phase 2 clinical trial included 156 patients with T2DM whose disease was not well controlled under treatment with metformin alone. In addition to metformin, patients were randomly assigned to receive either imeglimin or placebo (a substance with no medical effect used as control in testing new drugs). The main parameter evaluated was the value of the glycated hemoglobin or HbA1c (a test that shows the average level of blood sugar control from the last 2 to 3 months). 

After 12 weeks of treatment, in patients treated with metformin-imeglimin the value of HbA1c decreased with 0.65% from the beginning of treatment compared to patients who received metformin-placebo, whose HbA1c decreased only with 0.21%. Also, more patients treated with the combination metformin-imeglimin had a decrease in HbA1c value after treatment compared to patients in the metformin-placebo group (63.6% versus 36.4%). Metformin-imeglimin therapy was as well tolerated as metformin-placebo, with no significant side effects reported during the treatment period. 

In summary, this study showed that the addition of imeglimin to metformin therapy improved blood sugar control in patients with T2DM. This combination was safe and well tolerated and offers a potential new treatment option for patients with T2DM uncontrolled with metformin alone. 

A possible limitation of this study is the small study group and the short follow up period. Also, imeglimin is not yet approved by the U.S. FDA for the treatment of patients with T2DM. Larger studeis are expected to confirm the results of this research.

This study was funded by Poxel SA, the manufacturer of imeglimin.