Phase III, 16-week, double-blind, placebo-controlled, randomized trial of imeglimin in patients with type 2 diabetes mellitus
Phase of Trial: Phase III
Latest Information Update: 27 Dec 2017
At a glance
- Drugs Imeglimin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms TIMES 3
- Sponsors Poxel; Sumitomo Dainippon Pharma
- 27 Dec 2017 Status changed from planning to recruiting, as reported in a Poxel media release.
- 30 Oct 2017 According to a Sumitomo Dainippon Pharma media release, this trial is a part of the phase III program in Japan that includes 3 pivotal studies with approximately 1100 patients that will support regulatory submissions to the Pharmaceuticals and Medical Devices Agency (PMDA). This trial is expected to be initiated by the end of 2017.
- 12 Sep 2016 According to a company media release, Poxel expects to initiate this trial during the fourth quarter of 2017.