Trial name | Year | Drug class | Exp. Vs control arms | Centers and countries, n. | Primary endpoint and key secondary endpoint | Follow-up, median in years | Patients, n. Exp.: n. Control | Age, mean in years | Diabetes duration, median in years | Male, n (%) | BMI, kg/m2 | HbA1c, median,  % | Established CVD, n (%) | Previous HF, n (%) | EGFR < 60 mL/min per 1.73 m2, n (%) |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ELIXA | 2015 | GLP-1 | Lixisenatide vs placebo | 49 countries | 4-point MACE and expanded MACE | 2.1 | 3034:3034 | 60.3 | 9.3 | 4207 (69) | 30.2 | 7.6 | 6068 (100) | 1358 (22) | 1407 (23) |
LEADER | 2016 | GLP-1 | Liraglutide vs placebo | 410 sites in 32 countries | 3-point MACE and expanded MACE | 3.8 | 4668:4672 | 64.3 | 12.8 | 6003 (64) | 32.5 | 8.7 | 7598 (81) | 1305 (14) | 2158 (23) |
SUSTAIN-6 | 2016 | GLP-1 | Semaglutide vs placebo | 230 sites in 20 countries | 3-point MACE and expanded MACE | 2.1 | 1648:1649 | 64.6 | 13.9 | 2002 (61) | 32.8 | 8.7 | 2735 (83) | 777 (24) | 939 (28) |
EXSCEL | 2017 | GLP-1 | Exenatide vs placebo | 687 sites in 35 countries | 3-point MACE and MACE components | 3.2 | 7356:7396 | 62 | 12 | 5603 (62) | 31.8 | 8 | 10782 (73) | 464 (3) | 1129 (8) |
HARMONY | 2018 | GLP-1 | Albiglutide vs placebo | 610 sites in 28 countries | 3-point MACE and expanded MACE | 1.6 | 4731:4732 | 64.1 | 14.1 | 6569 (69) | 32.3 | 8.8 | 9463 (100) | 1922 (20) | 2222 (23) |
REWIND | 2019 | GLP-1 | Dulaglutide vs placebo | 371 sites in 24 countries | 3-point MACE and 7 secondary outcomesa | 5.4 | 4949:4952 | 66.2 | 9.5 | 5312 (54) | 32.3 | 7.3 | 3114 (31) | 853 (8.6) | 2199 (22) |
PIONEER-6 | 2019 | GLP-1 | Semaglutidevs placebo | 214 sites in 21 countries | 3-point MACE and other CVD outcomesc | 2.6 | 1591:1592 | 66 | 14.9 | 2176 (68) | 32.3 | 8.2 | 2695 (85)d | 388 (12.2) | 856 (27) |
EMPA-REG OUTCOME | 2015 | SGLT-2 | Empagliflozin vs placebo | 590 sites in 42 countries | 3-point MACE and 4-point MACE | 3.1 | 4687:2333 | 63.1 | 10b | Â 3336 (71) | 30.7 | 8.1 | 7020 (100) | 706 (10) | 1819 (26) |
CANVAS | 2017 | SGLT-2 | Canagliflozin vs placebo | 667 sites in 30 countries | 3-point MACE and all-cause and CVD deaths | 2.4 | 5795:4347 | 63.3 | 13.5 | 6509 (64) | 32 | 8.2 | 6656 (66) | 1461 (14) | 2039 (20) |
DECLARE | 2019 | SGLT-2 | Dapagliflozin vs placebo | 882 sites in 33 countries | 3-point MACE and CVD mortality + HF hospitalizations | 4.2 | 8582:8578 | 63.9 | 11.0 | 10738 (63) | 32.1 | 8.3 | 6974 (41) | 1724 (10) | 1265 (7) |