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NCT Number: NCT05366868

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center Hospital of the National Center for Global Health and Medicine

Shinjuku-Ku, Tokyo, 162-8655, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imeglimin

Drug

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

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.

Vildagliptin

Drug

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

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.

    Time frame: From 16 to 156 weeks after the start of study drug administration

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Maximum decrease in HbA1c level during the observation period

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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

National Center for Global Health and Medicine, Japan

Other Gov

Collaborators

  • Sumitomo Pharma Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 9, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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