Type 2 diabetes
Conditions
Interventions
We give dapagliflozin 5mg/day after an agreement for 36 months, extend if possible. Evaluate
before and 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible Observation period
From May1,2016 to reach planned number of cases
Sponsors
Tonami general hospital Department of diabetes mellitus and endocrinology
Department of pharmacokinetics, Kyoto pharmaceutical university
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Type 2 diabetes BMI 23kg/m2<= eGFR30ml/min/1.73m2<=
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose and HbA1c after administration 1, 3, 6, 9, 12, 18, 24, 36 months later, every 12 months thereafter if possible. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTetsuo Hayakawa
Tonami general hospital Department of diabetes mellitus and endocrinology
Outcome results
None listed