Effect of canagliflozin in type 2 diabetic patients with microalbuminuria in Japanese populatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

1. Man or woman with a diagnosis of type 2 diabetes
2. Age >= 20 to < 75 years at time of informed consent
3. Glycated hemoglobin (HbA1c) >= 6.5 % and < 11.0% at visit 1
4. Geometric mean of 2 first morning voided urinary albumin-to-creatinine ratio >= 50 to < 300 mg/gCr at visit 2 and visit 3
5. Estimated glomerular filtration rate (eGFR) >= 45 mL/min per 1.73m2 at visit 1
6. All subjects are required to have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria

1. Use of SGLT2 inhibitor <= 12 weeks prior to informed consent
2. Known allergies or hypersensitivity to canagliflozin or other SGLT2 inhibitors
3. History of severe diabetic ketosis (including ketoacidosis), diabetic coma or pre-coma
4. Severe infection, pre- or post-surgery (ie, requiring general anesthesia) or severe trauma at visit1 or visit 3
5. Urinary tract infection or genital infection at visit1 or visit 3
6. Underlying renal disease other than diabetic nephropathy at visit1 or visit 3
7. New York Heart Association Class IV cardiac disease at visit1 or visit 3
8. Severe hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg) at visit1 or visit 3
9. History of arteriosclerosis obliterans and/or foot ulcer and/or limb amputation
10. Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
11. Medical history of cancer and/or treatment for cancer within the last 5 years at visit1 or visit 3
12. Severe liver disease at visit1 or visit 3
13. Treatment with systemic steroids at visit1 or visit 3
14. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) at visit1 or visit 3
15. Reduction in eGFR >= 30% from visit 1 to visit 3
16. Any condition that, in the opinion of the investigator, would compromise the subject's well-being or ability to perform the study requirements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Longitudinal profile of change in urinary albumin-to-creatinine ratio (UACR) from baseline to intervention period (week 4 to 52) <br>2. Change in eGFR slope

Secondary Outcome Measures

Name	Time	Method
1. Change in eGFR from baseline to the end of the washout period <br>2. Progression to macroalbuminuria <br>3. Regression to normoalbuminuria <br>4. Change in eGFR from week 52 to the end of washout period <br>5. Chronic eGFR slope<br>6. Change in UACR from baseline to each visit in the intervention period <br>7. Comparison of change in UACR by canagliflozin between participants taking ACE inhibitor and/or ARB and participants taking neither ACE inhibitor nor ARB <br>8. Changes in HbA1c, body mass index, and blood pressure <br>9. Occurrence of cardiovascular event

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