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

PHASE4RecruitingINTERVENTIONAL
Enrollment

567

Participants

Timeline

Start Date

May 26, 2022

Primary Completion Date

August 31, 2026

Study Completion Date

March 31, 2027

Conditions
Diabetes Mellitus, Type 2
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).

Trial Locations (1)

162-8655

RECRUITING

Center Hospital of the National Center for Global Health and Medicine, Shinjuku-Ku

All Listed Sponsors
collaborator

Sumitomo Pharma Co., Ltd.

INDUSTRY

lead

National Center for Global Health and Medicine, Japan

OTHER_GOV