Prospective study of the efficacy of imeglimin and metformin against insulin secretion and resistance in patients with type 2 diabetes

JRCT ID: jRCTs051220075

Registered date:16/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes
• Date of first enrollment: 16/08/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Study subjects whose eligibility has been confirmed and written consent has been obtained will be enrolled and randomly assigned to the imeglimin or metformin group according to a pre-designed allocation table. Research subjects will be administered an oral glucose tolerance test by the physician before, 12 weeks, and 24 weeks after the administration of the therapeutic agent.

Outcome(s)

• Primary Outcome: Change in HbA1c from baseline to observation points 12 and 24 weeks in each group

Secondary Outcome

1. Change in blood glucose, insulin, C-peptide, glucagon, GLP-1, intact GLP-1, GIP, intact GIP (each point, AUC) in OGTT from baseline (observation point 0 week) to observation point 12, 24 weeks in each group
2. Change in insulinogenic index, HOMA-IR, and HOMA-beta from baseline (observation point 0 week) to observation points 12 and 24 weeks in each group
3. Change in insulin resistance index (SI) using the oral minimal model from baseline (observation point 0 week) to observation points 12 and 24 weeks in each group
4. Change in insulin secretion index (phai, DI) using the oral minimal model from baseline (Week 0) to Weeks 12 and 24 in each group
5. Incidence of adverse events and disease from baseline (Week 0) to Weeks 12 and 24 in each group
6. Comparison of change in primary endpoint and secondary endpoint 1 (change in AUC), and 2-5 between the imeglimin and metformin groups

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients with type 2 diabetes
2) Tha age is more than 18 and less than 75
3) Patients who receive no anit-diabetic drugs, oronly one kind of anit-diabetic drug; sulfonylurea, glinide, alpha-glucosidase inhibitor, DPP-4inhibitor, pioglitazone, or SGLT2 inhibitor.
4) HbA1c 7.0-9.0%(Patients who receive no anit-diabetic drugs), HbA1c 6.0%-8.0% (Patients who re
ceive only one kind of anit-diabetic drug
5) BMI is more than 18kg/m2 and less than 35kg/m2
6) Hb is more than 12.5g/dL (male) or 12.0g/dL (female)
7) Patiets who agree to participate in this study by the agreement form

Exclude criteria

1) Patients with renal dysfunction (eGFR is less than 45mL/min/1.73m2)
2) Patients who receive metformin, imeglimin insulin, or GLP-1 receptor agonitst.
3) Patients with hepatic dysfunction (AST, ALT, gammma-GTP is above 3 fold of ULN)
4) Patients receiving SGLT2 inhibitors and diagnosed heart failure
5) Severe retinopathy (Proliferative Diabetic Retinopathy or vitreous hemorrhage)
6) Patients with a history of gastrointestinal surgery
7) Patients with a history of malignancy within 5 years
8) Patients with severe infection, perioperative, or severe trauma
9) Patients with excessive drinking habits (more than 5 days a week)
10) Patients who have difficulty following the instructions of the principal investigator or sub-investigator
11) Patients who are participating in other clinicaltrials, clinical research, etc.
12) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study

Related Information

• Primary Sponsor: Hamamoto Yoshiyuki
• Source(s) of Monetary Support: Sumitomo Pharma Co., Ltd.