Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients with type 2 diabetes study

UMIN ID: UMIN000018930

Registered date:07/09/2015

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type 2 diabetes with albuminuria
• Date of first enrollment: 2015/09/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: 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 Outcome: 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).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Yokohama City University Hospital
• Source(s) of Monetary Support: AstraZeneca and Ono Pharmaceutical co. LTD
• Secondary ID(s): VT AZ MEDI_ESR-14-10420