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Randomized Controlled Trial
. 2013 Mar;36(3):565-8.
doi: 10.2337/dc12-0453. Epub 2012 Nov 16.

The efficacy and safety of imeglimin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy

Pascale Fouqueray  1 , Valdis Pirags, Silvio E Inzucchi, Clifford J Bailey, Guntram Schernthaner, Michaela Diamant, Harold E Lebovitz
Affiliations
Randomized Controlled Trial

The efficacy and safety of imeglimin as add-on therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy

Pascale Fouqueray et al. Diabetes Care. 2013 Mar.

Abstract

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.

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References

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