A phase III, double-blind, insulin-combination therapy study of imeglimin (TIMES 3)
Phase of Trial: Phase III
Latest Information Update: 22 Mar 2018
At a glance
- Drugs Imeglimin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Acronyms TIMES 3
- Sponsors Poxel; Sumitomo Dainippon Pharma
- 22 Mar 2018 According to Poxel media release, data readout is expected in 2019 and submission of Japanese new drug application in 2020.
- 13 Mar 2018 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.