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

Diabetes Mellitus, Type 2 Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366868
• Other study ID #: 004371
• Secondary ID: jRCTs051180211
• Status: Recruiting
• Phase: Phase 4
• Start date: May 26, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: November 2023
• Source: National Center for Global Health and Medicine, Japan
• Contact: Kohjiro Ueki, M.D., Ph.D.
• Phone: +813-5273-5355
• Email: uekik[@]ri.ncgm.go.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 567
• Est. completion date: March 31, 2027
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of obtaining consent.

2. 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.

3. Patients whose HbA1c level is between 7.0% and 9.0% as measured at the time of the eligibility test.

4. Patients who have given written consent to participate in this study.

Exclusion Criteria:

When consent is obtained

1. Patients with type 1 diabetes mellitus

2. Patients who have been given more than 2 oral hypoglycemic drugs within 12 weeks

3. 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

4. Patients with proliferative retinopathy (except for patients with stable treated proliferative retinopathy)

5. Patients with severe diabetic neuropathy (patients with severe symptoms and significant support for daily life)

6. Patients with a contraindication to Imeglimin, Metformin, or Vildagliptin

7. Patients with severe obesity (BMI 35 kg/m^2 or more)

8. Patients with NYHA (New York Heart Association) cardiac function classification of Grade III or IV within 1 year of evaluation

9. Excessive regular drinkers

10. Patients with a previous history of lactic acidosis

11. Patients with severe cachexia, diabetic coma or precoma

12. Patients with severe infections, surgical patients and those with serious injuries

13. Patients who are pregnant, who are planning to be pregnant, or who are breastfeeding

14. Patients who are undergoing treatment for malignancy or those with a history of treatment for malignancy within 5 years

15. Patients who are participating in a clinical study with other interventions

16. Patients to whom a responsible physician/investigator judged inappropriate for participating in the study In case of eligibility testing

17. Patients with an estimated glomerular filtration rate(eGFR) of 45 mL/min/1.73m^2 or less including those undergoing dialysis

18. Patients with severe hepatic disorders (Child-Pugh classification Grade C)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Imeglimin
Imeglimin 1000 mg orally twice daily in the morning and evening (2000 mg daily).
• Metformin
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
Vildagliptin 50 mg orally twice daily in the morning and evening (100 mg daily).

Locations

Country	Name	City	State
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-Ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Global Health and Medicine, Japan	Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Maximum decrease in HbA1c level during the observation period		From 0 to 156 weeks after the start of study drug administration
Secondary	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
Secondary	Number of times of achieving HbA1c level less than 7.0% during the observation period		From 0 to 156 weeks after the start of study drug administration
Secondary	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		From 0 to 156 weeks after the start of study drug administration