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

JRCT ID: jRCTs061180047

Registered date:12/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 diabetes with microalbuminuria
• Date of first enrollment: 21/08/2018
• Target sample size: 110
• Study type: Interventional

Intervention(s)

Canagliflozin treatment group:
Participants assigned to canagliflozin treatment will take a canagliflozin 100 mg tablet once daily for 52 weeks
Control group:
Participants assigned to the control group will receive treatment with drugs other than SGLT2 inhibitor for 52 weeks

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyamoto Satoshi
• Source(s) of Monetary Support: Mitsubishi Tanabe Pharma
• Secondary ID(s): UMIN000029905