| EMPA-REG | CANVAS | DECLARE-TIMI 58 |
---|---|---|---|
No. of patients | 7,028 | 10,142 | 17,160 |
Inclusion criteria | Â | Â | Â |
Type 2 diabetes | Type 2 diabetes | Type 2 diabetes | |
 | HbA1c ≥ 7% and ≤ 10% |  |  |
 | ≥ 18 years | ≥ 30 years or ≥ 50 years (s.b.) | ≥ 40 years |
Cardiovascular (CV) diseases | Established CV diseases | a) ≥ 30 years and history of symptomatic CV diseases or b) ≥ 50 years and ≥ 2 risk factors for CV diseases (duration of type 2 diabetes ≥ 10 years, systolic blood pressure > 140 mmHg (blood pressure–lowering treatment), current daily cigarette smoker, documented micro- or macroalbuminuria, or high-density lipoprotein (HDL) cholesterol of < 1 mmol/l (< 39 mg/dl) | a) Est. CV (40.6%) or b) ≥ 2 risk factors for it (age (≥ 55 years male ≥ 60 years female), dyslipidemia, hypertension, current tobacco use) (59.5%) |
Medication | Possible, incl. insulin | Possible, antihyperglycemic agents as mono- or combination therapy | Possible with antihyperglycemic agents |
Outcomes | Â | Â | Â |
Cardiovascular | Significant lower risk of death from CV (hazard ratio, 0.62 (95% CI, 0.49 to 0.77)) or any cause (hazard ratio, 0.68 (95% CI, 0.57 to 0.82)) | Reduced occurrence of death from CV causes, nonfatal myocardial infarction, nonfatal stroke (hazard ratio, 0.86 (95% CI, 0.75 to 0.97)) | Reduced occurrence of CV death, myocardial infarction or ischemic stroke (hazard ratio, 0.93 (95% CI, 0.84 to 1.03)) |
Hospitalization | Significant lower risk of hospitalization for heart failure (hazard ratio, 0.65 (95% CI, 0.50 to 0.85)) | Lower risk of hospitalization for heart failure (hazard ratio, 0.67 (95% CI, 0.52 to 0.87)) | Lower risk for hospitalization for heart failure (hazard ratio, 0.83 (95% CI, 0.73 to 0.95)) |
Other | Lower glycated hemoglobin levels (after 12 weeks with decreasing impact), slight reduction in weight, waist circumference, uric acid level and blood pressure (systolic and diastolic); slight increase of LDL and HDL cholesterol | Lower glycated hemoglobin levels, slight reduction in weight, waist circumference, blood pressure (systolic and diastolic); slight increase of LDL and HDL cholesterol | Lower glycated hemoglobin levels, slight reduction in weight and blood pressure (systolic and diastolic) |
Adverse side effects | Genital infections | Genital infections, higher risk of amputations (toe or metatarsal) and increased bone fractures with existing burden | Genital infections |