Durable Effect of Imeglimin on the Glycemic Control in Patients With Type 2 Diabetes Mellitus

NCT05366868 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: 004371jRCTs051180211
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  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

  From 0 to 156 weeks after the start of study drug administration

• Maximum decrease in HbA1c level during the observation period

  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

  From 0 to 156 weeks after the start of study drug administration

Study Arms (3)

Imeglimin

EXPERIMENTAL

Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).

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.

Drug: Metformin

Vildagliptin

ACTIVE COMPARATOR

Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).

Drug: Vildagliptin

Interventions

Imeglimin DRUG

Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).

Imeglimin

Metformin DRUG

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.

Metformin

Vildagliptin DRUG

Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).

Vildagliptin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sumitomo Pharma Co., Ltd.: collaborator
• National Center for Global Health and Medicine, Japan: lead

Study Sites (1)

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, 162-8655, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

imeglimin; Metformin; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kohjiro Ueki, M.D., Ph.D.

  Center Hospital of the National Center for Global Health and Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes Research Center, Research Institute

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: May 9, 2022
• Study Start: May 26, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

JP (1)