Diabetes Mellitus, Type 2Phase 4NCT05366868
Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
A Phase 4 study testing Imeglimin, Metformin and Vildagliptin in people with Diabetes Mellitus, Type 2, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Imeglimin, Metformin and Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 1 siteJapan
- Study dates
- 26 May 2022to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
- 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.
- Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
- Patients who have given written consent to participate in this study.
Who cannot join
- When consent is obtained
- Patients with type 1 diabetes mellitus
- Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
- 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
- Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
- Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)
Show all 19Show fewer
- Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
- Patients with severe obesity (BMI 35 kg/m^2 or more)
- Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
- Excessive regular drinkers
- Patients with a previous history of lactic acidosis
- Patients with severe cachexia, diabetic coma or precoma
- Patients with severe infections, surgical patients and those with serious injuries
- Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
- Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
- Patients who are participating in a clinical study with other interventions
- Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing
- Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m^2 or less including those undergoing dialysis
- Patients with severe hepatic disorders (Child-Pugh classification Grade C)
Trial locations and contacts
1 site in 1 country.
Japan1 site
Center Hospital of the National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655
About this study
Official title: Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Imeglimin, Metformin, Vildagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImegliminDrug
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
MetforminDrug
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.
VildagliptinDrug
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).
| Study group | Role | What they receive |
|---|---|---|
| Imeglimin | Experimental | Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily). Receives: Drug: Imeglimin |
| Metformin | Active comparator | 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. Receives: Drug: Metformin |
| Vildagliptin | Active comparator | Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily). Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16.
Measured: From 16 to 156 weeks after the start of study drug administration
Secondary outcomes (7)
Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16
Measured: From 16 to 156 weeks after the start of study drug administration
Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16.
Measured: From 16 to 156 weeks after the start of study drug administration
HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point
Measured: From 0 to 156 weeks after the start of study drug administration
Maximum decrease in HbA1c level during the observation period
Measured: From 0 to 156 weeks after the start of study drug administration
Proportion of patients achieving HbA1c level less than 7.0% at each measurement point
Measured: From 0 to 156 weeks after the start of study drug administration
Number of times of achieving HbA1c level less than 7.0% during the observation period
Measured: From 0 to 156 weeks after the start of study drug administration
Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics
Measured: From 0 to 156 weeks after the start of study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start26 May 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 567 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Global Health and Medicine, Japan
- Sponsor type
- Other government
- Collaborators
- Sumitomo Pharma Co., Ltd.
- Responsible party
- Principal investigator, Kohjiro Ueki, National Center for Global Health and Medicine, Japan
- Investigators
- Kohjiro Ueki, M.D., Ph.D., Principal investigator, Center Hospital of the National Center for Global Health and Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366868
- Sponsor's protocol ID
- 004371
- Other IDs
- jRCTs051180211
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus: a Multicenter, Open-label, Randomized, Controlled Trial (DIGNITY Trial)
- ClinicalTrials.gov ID
- NCT05366868
- Acronym / sponsor ID
- 004371
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 567 participants (estimated)
- Lead sponsor
- National Center for Global Health and Medicine, JapanOther government
- Collaborators
- Sumitomo Pharma Co., Ltd.
- Study start
- 26 May 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Imeglimin | Experimental | Drug: ImegliminImeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily). |
| Metformin | Active comparator | Drug: MetforminMetformin 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. |
| Vildagliptin | Active comparator | Drug: VildagliptinVildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.
- 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.
- Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.
- Patients who have given written consent to participate in this study.
Key exclusion criteria (19 listed)
- When consent is obtained
- Patients with type 1 diabetes mellitus
- Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks
- 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
- Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImegliminImeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily). | Drug | Imeglimin |
| MetforminMetformin 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 | Metformin |
| VildagliptinVildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily). | Drug | Vildagliptin |
Primary outcome
Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16.
Time frame: From 16 to 156 weeks after the start of study drug administration
7 secondary outcomes
Time from Week 0 to addition of a type 2 diabetes mellitus medication after Week 16
Time frame: From 16 to 156 weeks after the start of study drug administration
Time from detection of two consecutive HbA1c levels of 7.0% or higher to addition of a type 2 diabetes mellitus medication after Week 16.
Time frame: From 16 to 156 weeks after the start of study drug administration
HbA1c level, fasting blood glucose level, and their changes from baseline at each measurement point
Time frame: From 0 to 156 weeks after the start of study drug administration
Maximum decrease in HbA1c level during the observation period
Time frame: From 0 to 156 weeks after the start of study drug administration
Proportion of patients achieving HbA1c level less than 7.0% at each measurement point
Time frame: From 0 to 156 weeks after the start of study drug administration
Number of times of achieving HbA1c level less than 7.0% during the observation period
Time frame: From 0 to 156 weeks after the start of study drug administration
Time from Week 0 to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16 by patient characteristics
Time frame: From 0 to 156 weeks after the start of study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kohjiro Ueki, M.D., Ph.D. principal investigator
Center Hospital of the National Center for Global Health and Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Imeglimin, Metformin and Vildagliptin in people with Diabetes Mellitus, Type 2, run by National Center for Global Health and Medicine, Japan at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from study drug initiation (Week 0) to detection of two consecutive HbA1c levels of 7.0% or higher by laboratory tests after Week 16. (time frame: From 16 to 156 weeks after the start of study drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.