Table 1.

Comparative description of the major SGLT2i studies including a kidney endpoint

Name Of the StudyEMPA-REG OUTCOMECANVAS/CANVAS RDECLAREVERTISCREDENCEDAPA-CKDEMPAGLIFLOZIN RENAL
Clinical trial registrationNCT01131676NCT01032629 and NCT01989754NCT01730534NCT01986881NCT02065791NCT03036150TBA
InterventionEmpagliflozin versus placeboCanagliflozin versus placeboDapagliflozin versus placeboErtugliflozin versus placeboCanagliflozin versus placeboDapagliflozin versus placeboEmpagliflozin versus placebo
Patient populationDM2, high CV riskDM2, high CV riskDM2, high CV riskDM2, established vascular diseaseDM2, high CV riskDM2 and nonpatients with diabetes, high CV riskDM2 and nonpatients with diabetes, high CV risk
Kidney function inclusion criteriaeGFR≥30 ml/min per 1.73 m2eGFR≥30 ml/min per 1.73 m2eGFR≥30 ml/min per 1.73 m2eGFR≥30 ml/min per 1.73 m330≥ eGFR≤90 ml/min per 1.73 m2 (CKD 2 and 3)30≥ eGFR≤90 ml/min per 1.73 m3 (CKD 2 and 3)30≥ eGFR≤90 ml/min per 1.73 m4 (CKD 2 and 3)
Number of patients702110,14217,2768000 (estimated)44614000 (estimated)TBA
Prespecified renal endpointsIncident or worsening nephropathy (progression to macroalbuminuria, doubling of the serum creatinine level, initiation of RRT, or death from renal disease) and incident albuminuriaProgression to albuminuria, sustained 40% reduction in the eGFR, the need for RRT, or death from renal causesTime to first event of renal composite endpoint: Confirmed sustained ≥40% decrease in eGFR to eGFR<60 ml/min per 1.73 m2 and/or ESRD and/or renal or CV deathTime to composite of renal death, renal dialysis/transplant, or ≥2×increase in baseline serum creatinineTime to the first occurrence of an event in the primary composite endpoint (primary) ESRD, doubling of serum creatinine, renal or CV deathTime to the first occurrence of any of the components of the composite: ≥50% sustained decline in eGFR or reaching ESRD or CV death or renal deathTBA
OutcomesA 44% relative risk reduction of doubling of SCr (1.5% versus 2.6%); 38% relative risk reduction of progression to macroalbuminuria (11.2% versus 16.2%); 55% relative risk reduction of initiation of RRT (0.3% versus 0.6%); slowing GFR decline (annual decrease 0.19±0.11 versus 1.67±0.13 ml/min per 1.73 m2; P<0.001).Reduction in the progression of albuminuria (hazard ratio, 0.73; 95% CI, 0.67 to 0.79) and the composite outcome of a sustained 40% reduction in the eGFR, the need for RRT, or death from renal causesIn progress, estimated completion in April of 2019In progress, estimated completion in October of 2019In progress, estimated completion in June of 2019In progress, estimated completion in November of 2020TBA
  • eGFR is in millimeters per minute per 1.73 m2. Urine albumin-to-creatinine ratio is in milligrams per gram. EMPA-REG OUTCOME, Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients; CANVAS/CANVAS R, Canagliflozin Cardiovascular Assessment Study; DECLARE, Dapagliflozin Effect on Cardiovascular Events; VERTIS, Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants With Vascular Disease; CREDENCE, Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants with Diabetic Nephropathy; DAPA-CKD, A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With CKD; EMPAGLIFLOZIN RENAL, Empagliflozin Trial Kidney Outcome Trial in Chronic Kidney Disease; NCT, ClinicalTrials.gov Identifier, TBA, to be announced; DM2, diabetes mellitus type 2; CV, cardiovascular; SCr, serum creatinine; 95% CI, 95% confidence interval.