type 2 diabetes with albuminuria
Conditions
Interventions
Dapagliflozin therapy by oral administration of once-daily Forxiga 5 mg tablet will be performed for 24 weeks of protocol therapy period. To achieve the target HbA1c <
7.0% (NGSP), the dose of dapagliflozin may be increased to 10 mg daily (Forxiga 10 mg tablet), as needed.
Sponsors
Yokohama City University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Aged between 20 and < 80 years of age on day of signing informed consent (male/female) (2)Diagnosis of T2DM (3)CKD of G1-to-G3a categories (eGFR >=45 ml/min/1.73 m2) and A2-to-A3 categories (urine albumin-to-creatinine ratio, UACR >=30 mg/g-Cr) (4)Inadequate glycemic control, defined as HbA1c >=7.0% and <=10.0% (NGSP) (5)Written informed consent
Exclusion criteria
Exclusion criteria: (1)Patients who were planning a baby, pregnant, or breastfeeding women. (2)Significantly elevated creatinine kinase(CK) level (CK > 765U/L) (3)Severe hepatic insufficiency and/or significant abnormal liver function(AST > 96U/L and/or ALT > 135U/L) (4)New York Heart Association class IV congestive heart failure or acute congestive heart failure (5)A history of diabetic ketoacidosis, diabetic coma or pre coma within the past 6 months prior to the screening visit (6)Severe infection (7)Pre or post surgery (8)Serious trauma (9)Known hypersensitivity to dapagliflozin (10)On-going treatment with SGLT2 inhibitors or a history of treatment with SGLT2 inhibitors within 1month (11)Patients judged by the investigator to be ineligible for some other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint was the change in the natural logarithm of the UACR (mg/g-Cr) of the spot urine from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints were change from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment). Several measurements will be performed at 8 wks and 16 wks of protocol treatment for additional estimation. Efficacy endpoints: (1)Physical findings Body weight,BMI,clinic BP and PR (2)Urine analysis UPCR, U-Na/Cr, urine L-FABP/Cr, urine Col-IV/Cr, urine 8-OHdG/Cr (3)Glucose metabolism Fasting glucose, bA1c (4)Renal function Estimated glomerular filtration(eGFR) calculated using a revised equation for the Japanese population(27). The value of eGFR(mL/min/1.73 m2) = 194 X serum creatinine-1.094 X Age-0.287 X 0.739(if female). (5)Lipid metabolism LDL-cholesterol,HDL-cholesterol, total cholesterol, triglyceride, FFA (6)Oxidative stress and reduction power pentosidine, derivatives of reactive oxidative metabolites (d-ROMs),biological anti-oxidative potential (BAP) (7)Home BP analysis Home BP (morning, evening), day-by-day home BP variability, nighttime home BP, day-by-day nighttime home BP variability (8)Other measurement Dosage of dapagliflozin, achievement of target HbA1c levels (HbA1c <7.0%),transition of diabetic nephropathy stage (percentage of improvement, no change or worsening)renal composite outcome Safety outcomes: Representative adverse events which occur during the protocol therapy perid from the baseline (0 wks before treatment) to the endpoint (after 24 wks of protocol treatment). | — |
Countries
Japan
Contacts
Public ContactKouichi Tamura
Yokohama City University Hospital Department of Medical Science and Cardiorenal Medicine
Outcome results
None listed