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Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Sponsor: National Center for Global Health and Medicine, Japan
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
Conditions
Interventions
Imeglimin
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
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.
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