MedTrace Logo

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

NCT05366868 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 567

Last updated 2026-04-09

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Sumitomo Pharma Co., Ltd.

    collaborator INDUSTRY

  • National Center for Global Health and Medicine, Japan

    lead OTHER_GOV

Principal Investigators

  • Kohjiro Ueki, M.D., Ph.D. · Center Hospital of the National Center for Global Health and Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2026-08-31
Completion
2027-03-31

Countries

  • Japan

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05366868 on ClinicalTrials.gov