The efficacy and safety of imeglimin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy
P Fouqueray, V Pirags, SE Inzucchi, CJ Bailey… - Diabetes …, 2013 - Am Diabetes Assoc
P Fouqueray, V Pirags, SE Inzucchi, CJ Bailey, G Schernthaner, M Diamant, HE Lebovitz
Diabetes care, 2013•Am Diabetes AssocOBJECTIVE A 12-week study assessed the efficacy and safety of a new oral antidiabetic
agent, imeglimin, as add-on therapy in type 2 diabetes patients inadequately controlled with
metformin alone. RESEARCH DESIGN AND METHODS A total of 156 patients were
randomized 1: 1 to receive imeglimin (1,500 mg twice a day) or placebo added to a stable
dose of metformin (1,500–2,000 mg/day). Change in A1C from baseline was the primary
efficacy outcome; secondary outcomes included fasting plasma glucose (FPG) and …
agent, imeglimin, as add-on therapy in type 2 diabetes patients inadequately controlled with
metformin alone. RESEARCH DESIGN AND METHODS A total of 156 patients were
randomized 1: 1 to receive imeglimin (1,500 mg twice a day) or placebo added to a stable
dose of metformin (1,500–2,000 mg/day). Change in A1C from baseline was the primary
efficacy outcome; secondary outcomes included fasting plasma glucose (FPG) and …
OBJECTIVE
A 12-week study assessed the efficacy and safety of a new oral antidiabetic agent, imeglimin, as add-on therapy in type 2 diabetes patients inadequately controlled with metformin alone.
RESEARCH DESIGN AND METHODS
A total of 156 patients were randomized 1:1 to receive imeglimin (1,500 mg twice a day) or placebo added to a stable dose of metformin (1,500–2,000 mg/day). Change in A1C from baseline was the primary efficacy outcome; secondary outcomes included fasting plasma glucose (FPG) and proinsulin/insulin ratio.
RESULTS
After 12 weeks, the placebo-subtracted decrease in A1C with metformin-imeglimin was −0.44% (P < 0.001). Metformin-imeglimin also significantly improved FPG and the proinsulin/insulin ratio from baseline (−0.91 mg/dL and −7.5, respectively) compared with metformin-placebo (0.36 mg/dL and 11.81). Metformin-imeglimin therapy was generally well-tolerated with a comparable safety profile to metformin-placebo.
CONCLUSIONS
Addition of imeglimin to metformin improved glycemic control and offers potential as a new treatment for type 2 diabetes.
Am Diabetes Assoc