The Efficacy and Safety of Imeglimin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
- Pascale Fouqueray, MD1⇓,
- Valdis Pirags, MD2,
- Silvio E. Inzucchi, MD3,
- Clifford J. Bailey, PHD4,
- Guntram Schernthaner, MD5,
- Michaela Diamant, MD6 and
- Harold E. Lebovitz, MD7
- 1Poxel SA, Lyon, France
- 2Department of Internal Medicine, Paul Stradins Clinical University Hospital, Riga, Latvia
- 3Section of Endocrinology, Yale School of Medicine, New Haven, Connecticut
- 4School of Life and health Sciences, Aston University, Birmingham, United Kingdom
- 5Department of Internal Medicine, Rudolfstiftung Hospital, Vienna, Austria
- 6Diabetes Center/Department of Internal Medicine, VU University Medical Center, Amsterdam, the Netherlands
- 7Department of Medicine, State University of New York, Health Sciences Center, Brooklyn, New York
- Corresponding author: Pascale Fouqueray, .
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.
- Received March 7, 2012.
- Accepted August 26, 2012.
- © 2012 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.