Type 2 diabetes with microalbuminuria
Conditions
Interventions
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
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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) >= 7.0 % 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
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 time of informed consent or visit 3 5. Urinary tract infection or genital infection at time of informed consent or visit 3 6. Underlying renal disease other than diabetic nephropathy at time of informed consent or visit 3 7. New York Heart Association Class IV cardiac disease at time of informed consent or visit 3 8. Severe hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg) at time of informed consent 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 time of informed consent or visit 3 12. Severe liver disease at time of informed consent or visit 3 13. Treatment with systemic steroids at time of informed consent or visit 3 14. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) at time of informed consent 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in urinary albumin to creatinine ratio (ACR) from baseline to week 52 in the intervention period 2. Change in eGFR slope | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Change in urinary ACR from baseline to each visit in the intervention period 6. Comparison of change in urinary ACR by canagliflozin between participants taking ACE inhibitor and/or ARB and participants taking neither ACE inhibitor nor ARB 7. Changes in HbA1c, body mass index, and blood pressure 8. Occurrence of cardiovascular event | — |
Countries
Japan
Contacts
Public ContactSatoshi Miyamoto
Okayama University Hospital Center for Innovative Clinical Medicine
Outcome results
None listed