Efficacy and Safety of Imeglimin Monotherapy Versus Placebo in Japanese Patients with Type 2 Diabetes (TIMES 1): A Double-blind, Randomized, Placebo Controlled, Parallel-Group, Multicenter Phase 3 Trial

Type 2 diabetes is a widespread disease and often burdens patients with additional therapies for the treatment of co-morbidities. New therapeutic agents with durable efficacy and improved safety profiles are still the need of reality. Imeglimin is a first-in-class, novel, oral antidiabetic investigational agent for the treatment of type 2 diabetes. The author Julie Dubourg and colleagues conducted a study titled “Efficacy and Safety of Imeglimin Monotherapy Versus Placebo in Japanese Patients with Type 2 Diabetes (TIMES 1): A Double-blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Trial” published in the American Diabetes Association. The summary of the study is below:

Objective:

To assess the efficacy and safety of imeglimin.

Method:

This was a randomized, double-blind, parallel-group, placebo-controlled phase 3 trial conducted in 30 sites in Japan. Individuals aged >20 years with type 2 diabetes who were treated with diet and exercise, stable for >12 weeks prior to screening, and whose HbA1c was 7.0–10.0% were included. Patients were randomly assigned in 1:1 ratio to either oral imeglimin (1,000 mg twice daily) or matched placebo for 24 weeks. Investigators, sponsors, and the participants of the study remained blinded throughout the trial. The main outcome was the change in mean HbA1c from baseline to week 24, and the secondary outcome was the percentage of responders at week 24.

Findings:

The study found that imeglimin (1,000mg twice daily orally) for 24weeks significantly improved glycemic control and also insulin sensitivity, while reduced HbA1c and fasting plasma glucose (FPG) in Japanese patients with type 2 diabetes. Investigators report that both proinsulin-to-insulin and proinsulin-to-C peptide ratios were reduced in the imeglimin group as compared with placebo, while a decrease was only significant for the proinsulin-to-C-peptide ratio. Additionally, a significant improvement in HOMA-b values in the imeglimin group was observed, suggesting an improvement in pancreatic b-cell function.

As there is still an unmet medical need for elderly patients and for those with type 2 diabetes and CKD, these findings suggest that imeglimin might represent a new and safe treatment option in these populations.

Limitations:

This study was conducted with Japanese patients only and hence the findings might not be generalized without few considerations. As this was a 24-week study, the long-term safety and efficacy of imeglimin are still not known and need to be further evaluated.

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