New diabetes drug aims to keep blood sugar in check for years
NCT ID NCT05366868
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 Hide 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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