Effect of Canagliflozin in Non-
Conditions
Interventions
Patients will receive one 100-
mg Invokana® tablet after meal in the morning once daily for 24 weeks.,Patients will receive one matching placebo tablet after meal in the morning once daily for 24 weeks.
Experimental Drug,Experimental Drug
Invokana®,Matching placebo
Sponsors
Rachadaphiseksompot Endorsement Fund
Janssen-
Cilag.Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Overweight and obesity patients (BMI ≥ 25 kg/m2 and < 50 kg/m2). 2. Age 18 – 65 years. 3. Urine albumin 30-2000 mg/day evaluated by 24-hour urine collection on a stable dose of an ACEI or ARB for at least 4 weeks prior to randomization. 4. Estimated GFR ≥ 60 mL/min/1.73 m2 by CKD-EPI equation.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with diabetes mellitus prior to enrolement 2. Patients with secondary cause of obesity including Cushing’s syndrome, hypothyroidism, and syndromic obesity such as Prader-Willi syndrome 3. Patients with established peripheral arterial disease or history of limb amputation 4. Patients with specific causes of proteinuric kidney diseases including glomerulonephritis, nephrotic syndrome demonstrated by presence of urinary sediments 5. Evidence of preexisting renal tubular dysfunction including glucosuria in the absence of hyperglycemia 6. Systolic blood pressure 160/100 mmHg) or require ≥ 3 antihypertensive medications 8. Currently receiving GLP-1 agonist or DPP-4 inhibitor for any indications 9. History of urinary tract infection in the past 3 months 10. Pregnancy or breast-feeding woman 11. Obese patients scheduled to receive bariatric surgery within the next 6 months 12. Patients with recent episodes of heart failure, acute coronary syndrome, or stroke within the past 6 months 13. Patients with significant electrolytes or acid-base abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of change in urinary albumin at week 24 compared to baseline value at enrolment Week 24 24-hour urinary albumin | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of change in urinary biomaker (using urine LFABP and urine podocalyxin) Week 24 Spot urine LFABP and podocalyxin,Percentage of change in urinary fractional excretion of electrolytes and uric acid Week 24 Clotted blood/spot urine collection | — |
Countries
Thailand
Contacts
Public ContactPrimploy Greeviroj
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed