Study for the effects of imeglimin on glycemic control in patients with type 2 diabetes

JRCT ID: jRCT1011220005

Registered date:11/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 06/09/2022
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Addition of imeglimin 2,000 mg/day or increase metformin up to 1,000-2,000 mg/day (doubling). Participants in metformin group follow an escalation regimen of metformin (from 500 mg/day to 1,000 mg/day, from 750 mg/day to 1,500 mg/day, from 1,000 mg/day to 2,000 mg/day (maintenance dose reached after more than 4 weeks of 1,500 mg of metformin)). Metformin can be increased up to 2,250 mg/day in metformin group, however, maximum dose is limited to 1,500 mg/day in case of impaired GFR (45-60 mL/min/1.73m2) and/or 75 years old and above.

Outcome(s)

• Primary Outcome: The change in HbA1c at 24 weeks from baseline

Secondary Outcome

1) The change in the other blood and urinary tests
2) The change in weight, abdominal circumference, blood pressure and pulse
3) The change in indices of insulin secretion and insulin resistance
4) The change in scores of fatty liver disease
5) Adverse effects
6) The factors associated with improvement of HbA1c and secondary endopoints

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) Age 20-90 years old
2) HbA1c 7.0-10.0%
3) patients who were treated with DPP-4 inhibitors at least for 12 weeks (Sitagliptin, teneligliptin, and anagliptin: from regular dose to maximun dose; vildagliptin, saxagliptin, trelagliptin, linagliptin, alogliptin, and omarigliptin: regular dose)
4) written informed consent

Exclude criteria

1) history of anaphylaxis of imeglimin
2) inappropriate to increase metformin
3) unstable retinopathy
4) severe hepatic dysfunction, renal dysfunction (eGFR<45 mL/min/1.73m2), or heart failure
5) female patients who are pregnant and/or willing to be pregnant
6) severe ketosis, diabetic coma
7) severe infection, surgery, serious trauma
8) inability to consume an appropriate diet
9) incompatibility with the trial for other reasons, as determined by a physician

Related Information

• Primary Sponsor: Nomoto Hiroshi