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Imeglimin, a novel glimin oral antidiabetic, exhibits a good efficacy and safety profile in type 2 diabetic patients
Author(s) -
Pirags V.,
Lebovitz H.,
Fouqueray P.
Publication year - 2012
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/j.1463-1326.2012.01611.x
Subject(s) - metformin , tolerability , medicine , type 2 diabetes , placebo , adverse effect , diabetes mellitus , area under the curve , randomized controlled trial , gastroenterology , pharmacology , endocrinology , alternative medicine , pathology
Aims: Imeglimin is the first in a new tetrahydrotriazine‐containing class of oral antidiabetic agents, the glimins. It has been shown to act on the liver, muscle and pancreatic β ‐cells to uniquely target the key defects of type 2 diabetes. Two studies were performed to compare the safety and efficacy of imeglimin with metformin and placebo on glycaemic control in type 2 diabetes patients. Methods: In a 4‐week phase IIa, three‐arm parallel group study, patients were randomized to imeglimin 2000 mg once daily (od), imeglimin 1000 mg twice daily (bid) or metformin 850 mg bid and responses to an oral glucose tolerance test (OGTT) were measured. In an 8‐week phase IIa, four‐arm controlled multi‐centre study, patients were randomized to imeglimin 500 mg bid, imeglimin 1500 mg bid, metformin 850 mg bid or placebo. Glycaemic assessments included area under the curve (AUC) up to 6 h (AUC 0−6h ) for glucose during a prolonged meal, fasting plasma glucose (FPG) and HbA1c. Safety and tolerability were assessed in both studies through adverse event recording and laboratory parameters, vital signs and electrocardiogram. Results: Imeglimin was found to be as effective as metformin at reducing the AUC PG and AUC 0−6h , FPG and HbA1c. Imeglimin exhibited a favourable tolerability profile in comparison to metformin. Conclusions: The results from both studies confirm that imeglimin displays a superior benefit : risk profile compared with metformin in type 2 diabetes patients. The encouraging tolerability profile of imeglimin could make it suitable for combination with other classes of antidiabetic agents and may increase availability to a wider patient population.