Imeglimin add-on therapy:A randomized, double-blind, clinical trial

JRCT ID: jRCTs061210082

Registered date:04/03/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabete mellitus
• Date of first enrollment: 04/07/2022
• Target sample size: 200
• Study type: Interventional
• Intervention(s): To compare the DPP-4 inhibitor monotherapy group with the imeglimin addition group

Outcome(s)

• Primary Outcome: Measured from baseline in HbA1c level at 24 weeks

Secondary Outcome

1) Measured in HbA1c level from baseline (at regular visit)
2) Measured value of HbA1c level (at regular visit)
3) Percentage of patients achieving HbA1c target (<7.0% / <6.0%) (at 0, 24, 52 and 104 weeks)
4) Measured fasting blood glucose and change from baseline (at regular visits)
5) Measured change from baseline in glycoalbumin levels (at regular visits)
6) Measured value and change from baseline in area under the curve (AUC0-3h) from 0 to 3 hours postprandial blood glucose during the meal load test
and change from baseline (at 24, 52 and 104 weeks)
7) Measured value and change from baseline of postprandial serum insulin level AUC0-3h during the meal load test (24, 52, 104 weeks)
AUC0-3h and change from baseline (at 24, 52 and 104 weeks)
8) Measured postprandial serum Insulinogenic index and change from baseline at 24, 52 and 104 weeks
at 24, 52 and 104 weeks)
9) Measured value and change from baseline in Matsuda index at 24, 52 and 104 weeks during a food challenge test
10) Measured value and change from baseline in HOMA-IR at 24, 52 and 104 weeks
11) Measured value and change from baseline of HOMA-beta at 24, 52 and 104 weeks

Key inclusion & exclusion criteria

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

Include criteria

1) Outpatients diagnosed with type 2 diabetes mellitus who are 20 years of age or older at the time of consent
2) Patients who have been taking DPP-4 inhibitors for at least 12 weeks at the start of study treatment
3) Patients who have been on a diet and exercise regimen for at least 12 weeks at the start of study treatment
4)Patients with an HbA1c level between 7.0% and 9.0% on the test measured at the eligibility test
5) Patients with an HbA1c level within 10% of the variability between the HbA1c level measured most recently at the eligibility test and the HbA1c level measured at the time of the eligibility test between 10 weeks and 4 weeks prior to the eligibility test
6) Patients who have given written consent to participate in this study.

Exclude criteria

1) Patients with type 1 diabetes mellitus
2) Patients taking two or more oral hypoglycemic agents other than DPP-4 inhibitors at the time of consent
3) Patients who have been taking an oral hypoglycaemic drug other than a DPP-4 inhibitor within 12 weeks prior to the start of study treatment
4) Patients who have received a glucagon-like peptide receptor agonist or insulin within the last 6 months
5) Patients with proliferative retinopathy
6) Patients with severe diabetic neuropathy
7) Patients with contraindications to Imeglimin
8) Patients with impaired renal function, including patients on dialysis at the time of eligibility testing
9) Patients with severe hepatic impairment
10) Patients with New York Heart Association (NYHA) grade III or IV cardiac function at last evaluation within the last year
11) Excessive and regular drinkers
12) Pregnant women and patients who may be pregnant or lactating.
13) Patients with malignant tumours undergoing or within 5 years of completion of treatment.
14) Patients who are participating in a clinical study involving other interventions.
15) Any other patients who are deemed unsuitable for this study by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Shimoda Masashi
• Source(s) of Monetary Support: Sumitomo Pharma Co., Ltd.
• Secondary ID(s): Nil known