Table 1 Trial design
ELIXA [21] | LEADER [23] | SUSTAIN-6 [25] | EXSCEL [26] | Harmony Outcomes [29] | PIONEER 6 [31] | REWIND [33] | |
|---|---|---|---|---|---|---|---|
NCT number | NCT01147250 | NCT01179048 | NCT01720446 | NCT01144338 | NCT02465515 | NCT02692716 | NCT01394952 |
Drug | Lixisenatide | Liraglutide | Semaglutide | Exenatide | Albiglutide | Semaglutide | Dulaglutide |
Posology | Daily Subcutaneous | Daily Subcutaneous | Once-weekly Subcutaneous | Once-weekly Subcutaneous | Once-weekly Subcutaneous | Daily Oral | Once-weekly Subcutaneous |
Trial phase | III (pre-approval) | IIIb (post-approval) | III (pre-approval) | III/IV (post-approval) | IV (post-approval) | III (pre-approval) | III/IV (post-approval) |
Primary analysis | Non-inferiority (upper range of the two-sided 96% CI < 1.3) | Non-inferiority (upper range of the two-sided 95% CI < 1.3) | Non-inferiority (upper limit of the 95% CI < 1.8) | Superiority (upper limit of the 95% CI is < 1.00) | Non-inferiority (upper range of the two-sided 95% CI < 1.3) | Non-inferiority (upper limit of the 95% CI < 1.8) | Superiority |
Primary outcome | 4-point MACE: CV death, MI, stroke, or hospitalization for UA | 3-point MACE: CV death, MI, or stroke | 3-point MACE: CV death, MI, or stroke | 3-point MACE: CV death, MI, or stroke | 3-point MACE: CV death, MI, or stroke | 3-point MACE: CV death, MI, or stroke | 3-point MACE: CV death, MI, or stroke |