Study for the effects of switching from insulin to imeglimin in subjects with type 2 diabetes

Recruiting

• Conditions: Type 2 diabetes

• Registration Number: jRCT1011240025

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study Start: 2024-11-29
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age 20 years or older
2. Diagnosed with type 2 diabetes
3. Patients who were treated with frequent insulin injection therapy for 12 weeks or more prior to consent acquisition
4. HbA1c 6.0-9.0%
5. Patients taking less than 30 units of insulin per day in total
6. Outpatients
7. Written informed consent

Exclusion Criteria

1. Diagnosed with type 1 diabetes
2. Patients who have been administered imeglimin, sulfonylureas, or glinides within 8 weeks prior to obtaining consent
3. eGFR<45 mL/min/1.73m2
4. Fasting CPR<0.6 ng/mL and/or postprandial CPR<1.0 ng/mL
5. Female patients who are pregnant, lactating, and/or willing to be pregnant
6. History of anaphylaxis of imeglimin
7. Inability to consume an appropriate diet
8. Incompatibility with the trial for other reasons, as determined by a physician

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Change from baseline in DTSQs total score (sum of items 1, 4, 5, 6, 7, and 8) at 12 weeks