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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:
• Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
• Patients being treated with diet and exercise therapy only at the time of eligibility test However, if the patient is taking one oral hypoglycemic drug at the time of obtaining consent, the patient must be able to wash out the oral hypoglycemic drug for at least 12 weeks before the start of study treatment.
• Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
• Patients who have given written consent to participate in this study.
Locations
Other Locations
Japan
Center Hospital of the National Center for Global Health and Medicine
RECRUITING
Shinjuku-ku
Contact Information
Primary
Kohjiro Ueki, M.D., Ph.D.
uekik@ri.ncgm.go.jp
+813-5273-5355
Backup
Ryotaro Bouchi, M.D., Ph.D.
rybouchi@hosp.ncgm.go.jp
+813-3202-7181
Time Frame
Start Date:2022-05-26
Estimated Completion Date:2027-03-31
Participants
Target number of participants:567
Treatments
Experimental: Imeglimin
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
Active_comparator: 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.
Active_comparator: Vildagliptin
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).