The TIMES 1 trial
Imeglimin is a novel oral antidiabetes medication targeting the mitochondria. The TIMES 1 trial is part of the phase 3 program to support the approval of imeglimin in Japan, by assessing the effects of the medication on glycated hemoglobin levels when given as a monotherapy for 24 weeks.
The other two trials in the series will look at imeglimin in people taking other diabetes medications, and in those taking insulin.
Clinical testing of imeglimin for European/US approval is less well advanced. Three phase 2 studies have so far been published, testing imeglimin versus metformin or placebo, as an add-on to metformin, and as an add-on to sitagliptin. Plans for phase 3 testing have not yet been publicized.
Results from the TIMES 1 trial were presented at the 55th EASD Annual Meeting (EASD 2019):
Imeglimin: A first-in-class oral medication with a unique mechanism of action targeting mitochondrial bioenergetics
Wednesday, September 18, 12:00–13:00. Ochoa Hall, Fira Barcelona Gran Via, Spain
Session Chair: R. A. DeFronzo, USA
- The role of mitochondrial dysfunction in the pathophysiology of diabetes. R. A. DeFronzo, USA
- Clinical evidence to support the safety and efficacy of imeglimin in various populations of patients with type 2 diabetes. J. Dubourg, France
What our Editorial Board said: