Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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)
- 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)
Sites / Locations
- Center Hospital of the National Center for Global Health and MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Imeglimin
Metformin
Vildagliptin
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
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.
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).