Adults with type 2 diabetes
Conditions
Interventions
Treatment at obtaining consent is continued and 5 mg of dapagliflozin is orally administered once daily. In addition to everyday water intake, water or tea is taken in amount of 100 mL after each mea
Sponsors
Nonprofit Organization Hokkaido Health-Science Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Type 2 diabetic patients 2) Patients with HbA1c of 6.5% to 8.4% 3) Patients whose HbA1c is within 1% during the last 3 months 4) Hypertension patients who are treated with renin-angiotensin system inhibitor (referred as RAS inhibitor) from 8 weeks before screening or earlier (concomitant use of a direct renin inhibitor, an angiotensin-converting enzyme inhibitor or an angiotensin II receptor antagonist is to be prohibited) 5) Patients with BMI of 22.0 kg/m2 or higher 6) Patients from 20 years old but less than 75 years old at obtaining consent 7) Patients with eGFRcys of 45 mL/min/1.73m2 or higher 8) Patients having no dosing history of SGLT2 inhibitor within 4 months
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes, 2. Class III hypertension (SBP180 mmHg or more and/or DBP110 mmHg or more), 3. Clinical history (CH) of hypersensitivity to SGLT2 inhibitors, 4. Severe ketosis, diabetic coma or precoma, 5. Severe infectious disease, pre/post-surgery or serious trauma, 6. Severe renal dysfunction or end-stage renal failure under dialysis, 7. Pulmonary embolus or severe pulmonary function impediment, 8. Pituitary or adrenal gland dysfunction, 9. Status of dystrophy/starvation, irregular meal intake, dietary intake deficiency or hyposthenia. 10, Excessive alcohol intake. 11. CH of the following severe liver dysfunctions: AST and/or ALT100 U/L or more, total bilirubin 2.0 mg/dL (34.2 micromol/L)or more, 12. Dehydrated patients including those with non-functioning GIT such as diarrhea, vomiting or malignancy, 13. Complicated with malignancies, 14. Pregnant/ possible pregnant, breast-feeding, 15. Inappropriate patients for study participation judged by principal or clinical investigator, 16. Dosing of direct renin inhibitor, 17. Combined use of angiotensin-convertase inhibitor/ angiotensin II receptor antagonists, 18. Dosing of beta- or alpha,beta-blocking agent or its dosing history (DH) within 4 months, 19. Dosing of diuretic drugs or its DH within 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma renin activity (PRA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Group comparison of the following parameters before and after treatment 1) Physical examination Body weight, BMI, blood pressure, and pulse rate 2) Electrocardiogram 3) Hematology WBC, RBC, Hb, Ht, PLT 4) Biochemistry TC, HDL-C, TG, Cys-C, eGFRcys, Cr, BUN, UA,Na, K, Cl, HbA1c, and fasting blood sugar 5) Plasma aldosterone concentration (PAC) 6) AVP, BNP 7) Urinalysis Urine protein, urine sugar, specific gravity urine, urine sodium, urine potassium and urine chromium 8) Adverse events | — |
Countries
Japan
Contacts
Public ContactNaohide Noumi
IBEC Co., Ltd. CEO Office
Outcome results
None listed