type 2 diabetes
Conditions
Interventions
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
Sponsors
Nakamura Akinobu
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HbA1c at 24 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactAkinobu Nakamura
Hokkaido University
Outcome results
None listed