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New diabetes drug aims to keep blood sugar in check for years

NCT ID NCT05366868

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether the diabetes pill imeglimin can control blood sugar longer than two other common drugs, metformin and vildagliptin. About 567 adults with type 2 diabetes will take one of these pills for up to 3 years. The goal is to see which drug keeps HbA1c (a measure of blood sugar) below 7% the longest without needing extra medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Imeglimin (a diabetes pill)
What this could lead to
If successful, imeglimin could offer a new option for long-term blood sugar control in type 2 diabetes, potentially delaying the need for additional medications.
What could go wrong
This is a Phase 4 trial comparing imeglimin to existing drugs, so it's not testing a new breakthrough. The benefit may be modest, and individual results vary. Side effects are possible, as with any diabetes medication.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 567 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center Hospital of the National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo, 162-8655, Japan

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Other studies related to the condition(s) this trial covers.