Table 2

Summary of large clinical trials of the SGLT2-inhibitor class

Study titleStudy typeNumber of patients enrolledFollow-up duration (years)Study population
(key inclusion criteria)
Primary outcomeKey secondary outcomes
EMPA-REG OUTCOME59RCT
1:1:1
Empagliflozin 10 mg vs empagliflozin 25 mg vs placebo
70283.1Patients with:
  • Type 2 diabetes mellitus

  • Established CV disease

  • Body mass index ≤45 kg/m2

  • Glomerular filtration rate (GFR) >30

  • Reduction in CV death, non-fatal myocardial infraction or stroke in empagliflozin group vs placebo (HR 0.86, 95% CI 0.74 to 0.99)

  • All-cause mortality lower in empagliflozin vs placebo: p<0.01

  • HF hospitalisation lower in empagliflozin group vs placebo (HR 0.65, 95% CI 0.50 to 0.85)

  • HF hospitalisation and CV death (excluding fatal stroke) lower in empagliflozin group vs placebo (HR 0.66, 95% CI 0.55 to 0.79)

CANVAS trial60RCT
1:1:1
Canagliflozin 300 mg vs canagliflozin 100 mg vs placebo
10 1422.4Patients with:
  • Type 2 diabetes mellitus

  • High CV risk

  • CV death, non-fatal myocardial infarction or stroke (HR 0.86, 95% CI 0.75 to 0.87)

  • Reduction in CV death and HF hospitalisation greater in patients with known heart failure (HR 0.78, 95% CI 0.67 to 0.91)

DECLARE-TIMI 5861RCT
Dapagliflozin 10 mg vs placebo
17 1604.2Patients with:
  • Type 2 diabetes mellitus

  • Established CV disease or multiple risk factors

  • CV death, non-fatal myocardial infarction or stroke (HR 0.93, 95% CI 0.84 to 1.03)

  • Reduction in CV death or HF hospitalisation in dapagliflozin vs placebo (HR 0.83, 95% CI 0.73 to 0.95)

  • Reduction in HF hospitalisation (HR 0.73, 95% CI 0.61 to 0.88)

  • Reduction in death due to renal or CV causes (HR 0.53, 95% CI 0.43 to 0.66)

VERTIS CV trial62RCT
1:1:1
Ertugliflozin 5 mg vs ertugliflozin 15 mg vs placebo
82463.5Patients with:
  • Type 2 diabetes mellitus

  • Established CV disease

  • CV death, non-fatal MI or stroke (HR 0.97, 95% CI 0.85 to 1.11)

  • Lower HF hospitalisation in ertugliflozin group vs placebo (HR 0.70, 95% CI 0.54 to 0.90)

DAPA-HF trial63RCT
Dapagliflozin 10 mg vs placebo
47441.5Patients with:
  • Symptomatic heart failure

  • Left ventricular ejection fraction (LVEF) ≤40%

  • 50% patients with type 2 diabetes

  • Reduction in CV death, urgent heart failure visit or HF hospitalisation in dapagliflozin group vs placebo (HR 0.74, 95% CI 0.65 to 0.85)

  • Fewer HF symptoms reported on KCCQ in dapagliflozin group vs placebo (HR 1.18, 95% CI 0.65 to 0.85)

  • Reduction in CV death and HF hospitalisation (HR 0.75, 95% CI 0.65 to 0.85)

  • Benefits seen in both diabetics and non-diabetics

EMPEROR-Reduced trial64RCT
1:1 Empagliflozin 10 mg vs placebo
37301.5Patients with:
  • Chronic HF, NYHA class II/III/IV

  • LVEF ≤40%

  • HF hospitalisation within 12 months

  • 50% patients with type 2 diabetes

  • CV death or heart failure hospitalisation, for empagliflozin vs placebo (HR 0.75, 95% CI 0.65 to 0.86)

  • Composite renal outcome (chronic haemodialysis, renal transplantation, profound sustained reduction in eGFR): reduced in empagliflozin group vs placebo (HR 0.50, 95% CI 0.32 to 0.77)

  • All-cause mortality lower in empagliflozin group vs placebo (HR 0.92, 95% CI 0.77 to 1.10)

  • Benefits seen in both diabetics and non-diabetics

  • CI, Confidence interval ; CV, cardiovascular; HF, heart failure; HR, Hazard ratio; KCCQ, Kansas City Cardiomyopathy Questionnaire; MI, myocardial infarction; NYHA, New York Heart Association; RCT, randomised controlled trial.