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

JRCT ID: jRCT1011240025

Registered date:22/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 29/11/2024
• Target sample size: 36
• Study type: Interventional
• Intervention(s): In the Imeglimin add-on group, bolus insulin will be discontinued or changed, and administration of Imeglimin (2,000 mg/day) was started and continued until the end of the study. In the continuation group, multiple insulin injection therapy will be continued throughout the study period without any change in insulin administration method.

Outcome(s)

• Primary Outcome: Change from baseline in DTSQ total score (sum of items 1, 4, 5, 6, 7, and 8) at 12 weeks

Secondary Outcome

1) Change in HbA1c
2) Change in various blood and urine tests
3) Change in weight, waist circumference, blood pressure, pulse rate
4) Change in DTSQ score by item
5) Change in DEBQ score
6) Change in insulin secretion and resistance index
7) Change in fatty liver disease and liver fibrosis score
8) Change in total daily insulin dose
9) Presence and severity of disease, etc.
10) Change in various evaluation items in the patient group who did not require rescue treatment
11) Examination of factors that contributed to improvement in DTSQ score and secondary evaluation items

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitsunai Hiroya