NCT05366868

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 567 (estimated)
• Sponsor: National Center for Global Health and Medicine, Japan · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Study subjects will be randomly assigned to the three groups and receive the study drug for maximum of 156 weeks and undergo blood samplings and other diabetes mellitus-related tests. The aim of the present study is to evaluate the durability of glycemic control over 3 years for patients with type 2 diabetes on diet and exercise therapy treated with oral hypoglycemic drug monotherapy.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Imeglimin	Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
DRUG	Metformin	Metformin 500 mg orally twice daily in the morning and evening (1000 mg daily). However, until 2 weeks after the start of treatment, 250 mg should be administered orally twice daily in the morning and evening. Thereafter, after 4, 8, or 12 weeks, the dose may be increased up to 750 mg twice daily (1500 mg daily) if the physician determines that the hypoglycemic effect is inadequate.
DRUG	Vildagliptin	Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).

Timeline

• Start date: 2022-05-26
• Primary completion: 2026-08-31
• Completion: 2027-03-31
• First posted: 2022-05-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Japan