A phase III, open-label, monotherapy and combination therapy long-term study of imeglimin (TIMES 2)
Phase of Trial: Phase III
Latest Information Update: 28 Nov 2017
At a glance
- Drugs Imeglimin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational
- Acronyms TIMES 2
- Sponsors Cmic; Poxel; Sumitomo Dainippon Pharma
- 22 Nov 2017 Status changed from planning to recruiting.
- 31 Oct 2017 New trial record
- 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.