(HealthDay)—For patients with type 2 diabetes inadequately controlled by metformin alone, addition of the new oral anti-diabetes agent imeglimin improves glycemic control with good tolerability and safety, according to a study published online Nov. 16 in Diabetes Care.
Pascale Fouqueray, M.D., of Poxel in Lyon, France, and colleagues conducted a 12-week, phase II, randomized, controlled study involving 156 patients with type 2 diabetes who were inadequately controlled on metformin alone to assess the efficacy and safety of imeglimin as add-on therapy. Patients received a stable dose of metformin (1,500 to 2,000 mg/day) plus imeglimin (1,500 mg twice daily) or placebo.
After 12 weeks, the researchers found that the placebo-subtracted decrease in hemoglobin A1c was a significant −0.44 percent with metformin-imeglimin. Compared with metformin-placebo, metformin-imeglimin correlated with significant improvements in fasting plasma glucose and the proinsulin/insulin ratio from baseline. The safety profile of the metformin-imeglimin combination was similar to that of metformin-placebo, and the combination was generally well tolerated.
"This phase II study demonstrated that first-in-class imeglimin was well tolerated and effective when combined with metformin as a potential new treatment for type 2 diabetes," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Poxel, which primarily funded the study and manufactures imeglimin.
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