drugset / Trial / NCT05366868
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Phase 4
Active not recruiting
567 enrolled
National Center for Global Health and Medicine, Japan
Sumitomo Pharma Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-05-26
- Primary completion
- 2026-08-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imeglimin | Small molecule | 1000 mg | Oral |
| Comparator | Metformin | Small molecule | 500 mg | Oral |
| Comparator | Metformin | Small molecule | 750 mg | Oral |
| Comparator | Vildagliptin | Other / unclassified | 50 mg | Oral |