CREDENCE
Trial question
What is the role of canagliflozin in patients with T2DM and kidney disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 4401
4401 patients (1494 female, 2907 male).
Inclusion criteria: patients with T2DM and kidney disease.
Key exclusion criteria: diabetic ketoacidosis, T1DM mellitus, renal transplant, chronic dialysis, uncontrolled hypertension, MI, unstable angina, revascularization procedure.
Interventions
N=2202 canagliflozin (100 mg PO once daily).
N=2199 placebo (matching tablet).
Primary outcome
Incidence of ESRD, doubling of creatinine, renal death, or CV death
4.3% / y
6.1% / y
6.1 % / y
4.6 % / y
3.0 % / y
1.5 % / y
0.0 % / y
Canagliflozin
Placebo
Significant
decrease ▼
Significant decrease in the incidence of ESRD, doubling of creatinine, renal death, or CV death (4.3% / y vs. 6.1% / y; HR 0.7, 95% CI 0.59 to 0.82).
Secondary outcomes
No significant difference in death from any cause (5.8% vs. 9.1%; HR 0.83, 95% CI 0.68 to 1.02).
Significant decrease in CV death or hospitalization for HF (5.9% vs. 11.5%; HR 0.69, 95% CI 0.57 to 0.83).
Significant decrease in CV death, MI or CVA (9.9% vs. 12.2%; HR 0.8, 95% CI 0.67 to 0.95).
Safety outcomes
No significant differences in serious adverse events, including lower-limb amputation and fracture.
Conclusion
In patients with T2DM and kidney disease, canagliflozin was superior to placebo with respect to the incidence of ESRD, doubling of creatinine, renal death, or CV death.
Reference
Perkovic V, Jardine MJ, Neal B et al. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306.
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