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

Phase 4

Recruiting

• Conditions: type 2 diabetes

• Registration Number: JPRN-jRCT1011220005
• Lead Sponsor: omoto Hiroshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in HbA1c at 24 weeks from baseline

Secondary Outcome Measures

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