Type 2 diabetes
Conditions
Interventions
In the Imeglimin add-on group, bolus insulin will be discontinued or changed, and administration of Imeglimin (2,000 mg/day) was started and continued until the end of the study. In the continuation g
Sponsors
Kitsunai Hiroya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 years or older 2) Diagnosed with type 2 diabetes 3) Patients who were treated with frequent insulin injection therapy for 12 weeks or more prior to consent acquisition 4) HbA1c 6.0-9.0% 5) Patients taking less than 30 units of insulin per day in total 6) Outpatients 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Diagnosed with type 1 diabetes 2) Patients who have been administered imeglimin, sulfonylureas, or glinides within 8 weeks prior to obtaining consent 3) eGFR<45 mL/min/1.73m2 4) Fasting CPR<0.6 ng/mL and/or postprandial CPR<1.0 ng/mL 5) Female patients who are pregnant, lactating, and/or willing to be pregnant 6) History of anaphylaxis of imeglimin 7) Inability to consume an appropriate diet 8) Incompatibility with the trial for other reasons, as determined by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in DTSQs total score (sum of items 1, 4, 5, 6, 7, and 8) at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in HbA1c 2) Change in various blood and urine tests 3) Change in weight, waist circumference, blood pressure, pulse rate 4) Change in DTSQs score by item 5) Change in DEBQ score 6) Change in insulin secretion and resistance index 7) Change in fatty liver disease and liver fibrosis score 8) Change in total daily insulin dose 9) Presence and severity of disease, etc. 10) Change in various evaluation items in the patient group who did not require rescue treatment 11) Examination of factors that contributed to improvement in DTSQs score and secondary evaluation items 12) Diabetes Treatment Satisfaction Questionnaire (change: DTSQc) total score 13) DTSQc score by item | — |
Contacts
Public ContactHiroshi Nomoto
Asahikawa Medical University
Outcome results
None listed