Examination of the efficacy of dapagliflozin in patients with type 2 diabetes
Not Applicable
Recruiting
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000021954
- Lead Sponsor
- Tonami general hospital Department of diabetes mellitus and endocrinology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with hypersensitivity to an ingredient of dapagliflozin 2.Diabetic ketoacidosis 3.Past history of coma or severe hypoglycemia 4.Severe infection or serious trauma 5.Severe liver injury, renal failure, cardiac disease, proliferative retinopathy 6.Past history of cerebral infarction 7.Past history of malignant tumor 8.Women with during pregnancy, nursing, or pregnant likelihood 9.Inadequate patients judged by doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting plasma glucose and HbA1c after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible.
- Secondary Outcome Measures
Name Time Method Change of body weight, blood pressure, kidney and liver function, lipid profile, and blood dapagliflozin concentrations after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible. Blood dapagliflozin concentrations is measured until 36 months. Adverse event. Kidney function is urinary albumin, L-FABP and eGFR etc.