Clinical Trials

Date: 2017-12-27

Type of information: Treatment of the first patient

phase: 3

Announcement: treatment of the first patient

Company: Poxel (France) Sumitomo Dainippon Pharma (Japan)

Product: imeglimin

Action mechanism:

glimin. Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the glimins. Imeglimin acts on three main target organs involved in glucose homeostasis: the liver, the muscle, and the pancreas and has therefore a distinct mode of action compared to existing treatments for Type 2 diabetes. Imeglimin has shown a significant anti-diabetic efficacy combined with an excellent tolerance in earlier monotherapy clinical trials.
Imeglimin has completed Phase 2 development in over 850 patients in the United States, Europe and Japan.

Disease: type 2 diabetes

Therapeutic area: Metabolic diseases

Country: Japan

Trial details:

The TIMES (Trials of Imeglimin for Efficacy and Safety) program is a joint development effort between Poxel and Sumitomo Dainippon Pharma. The program will consist of three pivotal trials involving approximately 1,100 patients. The three trials will be performed using the dose of 1,000 mg twice daily:
TIMES 1: A Phase 3, 24-week, double-blind placebo-controlled, randomized, monotherapy study to assess the efficacy, safety and tolerability of Imeglimin in Japanese patients with type 2 diabetes, using the change in HbA1c as the primary endpoint. Secondary endpoints of the trial will include other standard glycemic and non-glycemic parameters.
TIMES 2: A Phase 3, 52-week, open-label, parallel-group study to assess the long-term safety and efficacy of Imeglimin in Japanese patients with type 2 diabetes. In this study, Imeglimin will be administrated orally as a monotherapy or combination therapy with existing hypoglycemic agents, including a DPP4 inhibitor, SGLT2 inhibitor, biguanide, sulphonylurea and GLP1 receptor agonist.
TIMES 3: A Phase 3, 16-week, double-blind, placebo-controlled, randomized study with a 36-week open-label extension period to evaluate the efficacy and safety of Imeglimin in combination with insulin in Japanese patients with type 2 diabetes and inadequate glycemic control on insulin therapy.

Latest news:

• On December 27, 2017, Poxel and Sumitomo Dainippon Pharma announced the initiation of the Phase 3 program for imeglimin in Japan. Referred to as TIMES (Trials of IMeglimin for Efficacy and Safety), the Imeglimin Phase 3 program in Japan will include three pivotal trials to evaluate Imeglimin’s efficacy and safety in approximately 1,100 patients. In December 2017, the first patient was included in the TIMES 1 trial, a multicenter, double-blind, placebo-controlled, randomized, monotherapy study in over 200 Japanese patients with type 2 diabetes.