NCT05366868Active, not recruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 567 (estimated)
- First submitted
- 15 Apr 2022
- Start date
- 26 May 2022
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- National Center for Global Health and Medicine, Japan
- Diseases
- Type 2 diabetes
- NCT number
- NCT05366868
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 567
- From 26 May 2022 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 a previous history of lactic acidosis
Other illness
- Patients with type 1 diabetes mellitus
- Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation
- Patients with severe infections, surgical patients and those with serious injuries
- Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years
- Patients with severe hepatic disorders (Child-Pugh classification Grade C)
Lab values
- Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m\^2 or less including those undergoing dialysis
Other
- When consent is obtained
- 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)
- Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin
- Patients with severe obesity (BMI 35 kg/m\^2 or more)
- Excessive regular drinkers
- Patients with severe cachexia, diabetic coma or precoma
- Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding
- 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
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center Hospital of the National Center for Global Health and Medicine Coordinator of this site? Confirm its status | Shinjuku-Ku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.