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


Autoria(s): Fouqueray, Pascale; Pirags, Valdis; Inzucchi, Silvio E.; Bailey, Clifford J.; Schernthaner, Guntram; Diamant, Michaela; Lebovitz, Harold E.
Data(s)

01/03/2013

Resumo

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 (1,500mg 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 20.44% (P <0.001). Metformin-imeglimin also significantly improved FPG and the proinsulin/insulin ratio from baseline (20.91 mg/dL and 27.5, respectively) compared with metformin-placebo (0.36 mg/dL and 11.81). Metformin-imeglimin therapy was generally welltolerated 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. Copyright © 2013 by the American Diabetes Association.

Formato

application/pdf

Identificador

http://eprints.aston.ac.uk/19853/1/Efficacy_and_safety_of_imeglimin_as_add_on_therapy_in_patientswith_type_2_diabetes_inadequately_controlled_with_metformin_monotherapy.pdf

Fouqueray, Pascale; Pirags, Valdis; Inzucchi, Silvio E.; Bailey, Clifford J.; Schernthaner, Guntram; Diamant, Michaela and Lebovitz, Harold E. (2013). The efficacy and safety of imeglimin as add-on therapy in patientswith type 2 diabetes inadequately controlled with metformin monotherapy. Diabetes Care, 36 (3), pp. 565-568.

Relação

http://eprints.aston.ac.uk/19853/

Tipo

Article

PeerReviewed