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)

Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus (NCT05366868) is a Phase 4 interventional studying Diabetes Mellitus, Type 2, sponsored by National Center for Global Health and Medicine, Japan. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 567 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent. 2. 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. 3. Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test. 4. Patients who have given written consent to participate in this study. Who Should NOT Join This Trial: When consent is obtained 1. Patients with type 1 diabetes mellitus 2. Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks 3. Patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less 4. Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy) 5. Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life) 6. Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin 7. Patients with severe obesity (BMI 35 kg/m\^2 or more) 8. Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation 9. Excessive regular drinkers 10. Patients with a previous history of lactic acidosis 11. Patients with severe cachexia, diabetic coma or precoma 12. Patients with severe infections, surgical patients and those with serious injuries 13. Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding 14. Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years 15. Patients who are participating in a clinical study with other interventions ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent. 2. 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. 3. Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test. 4. Patients who have given written consent to participate in this study. Exclusion Criteria: When consent is obtained 1. Patients with type 1 diabetes mellitus 2. Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks 3. Patients who have received glucagon like peptide-1 receptor agonist (short-term use of insulin for trauma or educational admission) within 1 year or less 4. Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy) 5. Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life) 6. Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin 7. Patients with severe obesity (BMI 35 kg/m\^2 or more) 8. Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation 9. Excessive regular drinkers 10. Patients with a previous history of lactic acidosis 11. Patients with severe cachexia, diabetic coma or precoma 12. Patients with severe infections, surgical patients and those with serious injuries 13. Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding 14. Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years 15. Patients who are participating in a clinical study with other interventions 16. Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing 17. Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m\^2 or less including those undergoing dialysis 18. Patients with severe hepatic disorders (Child-Pugh classification Grade C)

Treatments Being Tested

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).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05366868), the sponsor (National Center for Global Health and Medicine, Japan), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05366868 clinical trial studying?

Who can participate in NCT05366868?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05366868?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05366868. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05366868. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.