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ACTIVE NOT RECRUITING
NCT05366868
PHASE4

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

Sponsor: National Center for Global Health and Medicine, Japan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

567

Start Date

2022-05-26

Completion Date

2027-03-31

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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).

Locations (1)

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, Japan