JPRN-jRCT1011220005
Recruiting
Phase 4
Comparison of the effect on glycemic control between imeglimin and metformin in patients with type 2 diabetes -prospective randomized controlled trial
omoto Hiroshi0 sites70 target enrollmentMay 11, 2022
Conditionstype 2 diabetes
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- type 2 diabetes
- Sponsor
- omoto Hiroshi
- Enrollment
- 70
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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