type 2 diabetes mellitus (T2DM)
Conditions
Interventions
Not to add dapagliflozin
To add add dapagliflozin
Sponsors
Tokushima University Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age; 20 =< and <80 2. Type 2 diabetic patients receiving basal insulin therapy 3. Outpatients or inpatients 4. HbA1c; 7.0% =< and >= 10% 5. eGFR; 45mL/min/1.73m2 =< 6. Patient understands the purpose and procedures of the study, plus voluntarily agrees to participate in the study by giving written consent prior to study participation
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes mellitus, secondary diabetes mellitus 2. 3. Patients who have complications of severe hepatic disease , severe renal disease or receiving dialysis or recent 5 years malignancies. Patients with cardiovascular diseases (recent cardiovascular events, congestive heart failure, patients with uncontrolled high blood pressure) 4. Volume depleted patients (the study intends to enroll elderly patients over 65 who are more prone to volume depletion due to co-existing conditions and concomitant medications such as loop diuretics) 5. Patients with pregnancy, possible pregnancy, or on breast-feeding 6. Contraindication for the use of dapagliflozin 7. Patients who were received other sodium glucose cotransporter 2 inhibitor 8. Disqualified from the study by the primary investigator or a sub-investigator for any reason other than given above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean daily blood glucose level before (at Day 1-2) and after (at Day 3-4) add-on or no add-on of dapagliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| Day 3-4 Change in fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180 mg/dL, >=70 to <180 mg/dL and <70 mg/dL from baseline Week 4 Change in HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline Week 12 Change in the SD, mean and fluctuation of 24-h blood glucose level, mean amplitude of glucose excursion, the percentage of time with glucose level >=180mg/dL, >=70 to <180 mg/dL and <70 mg/dL, HbA1c, body composition, TG, HDL-C, LDL-C, chylomicron, VLDL, MDA-LDL, adiponectin, high-sensitive CRP, 8-isoprostane, blood pressure, body weight, BMI from baseline, Safety | — |
Countries
Japan
Contacts
Public ContactMichio Shimabukuro
Fukushima Medical University Department of Diabetes, Endocrinology and Metabolism School of Medicine
Outcome results
None listed