UMIN ID: UMIN000018930
Registered date:07/09/2015
Yokohama Add-on Inhibitory efficacy of Dapagliflozin on Albuminuria in Japanese patients with type 2 diabetes study
Basic Information
Recruitment status | Complete: follow-up complete |
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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) |
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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 |
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Age maximum | 80years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | AstraZeneca and Ono Pharmaceutical co. LTD |
Secondary ID(s) | VT AZ MEDI_ESR-14-10420 |
Contact
public contact | |
Name | Kouichi Tamura |
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan Japan 236-0004 |
Telephone | 045-787-2635 |
tamukou@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospital Department of Medical Science and Cardiorenal Medicine |
scientific contact | |
Name | Kouichi Tamura |
Address | 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan Japan |
Telephone | 045-787-2635 |
tamukou@yokohama-cu.ac.jp | |
Affiliation | Yokohama City University Hospital Department of Medical Science and Cardiorenal Medicine |