RecruitingPhase 4NCT05366868

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

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)


Sponsor

National Center for Global Health and Medicine, Japan

Enrollment

567 participants

Start Date

May 26, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the long-term effects of a diabetes drug called imeglimin (combined with metformin or another diabetes drug) on blood sugar control in people with type 2 diabetes in Japan. Researchers want to see if imeglimin keeps working well over time. **You may be eligible if...** - You are 20 or older and have type 2 diabetes - Your HbA1c (blood sugar average) is between 7.0% and 9.0% - You are currently managing your diabetes with diet/exercise alone, or with just one oral diabetes medication that can be stopped temporarily before the study **You may NOT be eligible if...** - You have type 1 diabetes - You have taken 2 or more oral diabetes medications within the past 12 weeks - You have taken a GLP-1 receptor agonist injection within the past year - You have severe obesity (BMI above 35) - You have severe heart failure (NYHA class III or IV) - You are pregnant or planning to become pregnant - You have severe kidney disease (eGFR below 45) - You have severe liver disease - You are currently being treated for cancer or have been in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGImeglimin

Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).

DRUGMetformin

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.

DRUGVildagliptin

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

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NCT05366868


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