Table 2.
Trial name, time until primary endpoint | Treatment arms | Permitted concomitant treatments | ETD HbA1c, % [95% CI]; P‐value (vs placebo) | ETD body weight, kg [95% CI]; P‐value (vs placebo) |
---|---|---|---|---|
AWARD‐1 15 , 26 weeks | Dulaglutide 0.75 mg | Metformin and/or pioglitazone | −0.84 [−1.01; −0.67]; <.001 | 1.27 [95% CI: NR]; <.001 a |
Dulaglutide 1.5 mg | −1.05 [−1.22; −0.88]; <.001 | −0.24 [95% CI: NR]; .474 a | ||
Exenatide BID 10 µg | ||||
Placebo | ||||
AWARD‐8 24 , 24 weeks | Dulaglutide 1.5 mg | Glimepiride | −1.3 [−1.6; −1.0]; <.001 | −0.68 [−1.53; 0.18]; NS |
Placebo | ||||
AWARD‐9 25 , 28 weeks | Dulaglutide 1.5 mg | Insulin glargine ± metformin | −0.77 [−0.97; −0.56]; <.001 | −2.41 [−3.19; −1.64]; <.001 |
Placebo | ||||
REWIND 7 (median follow‐up 5.4 years) | Dulaglutide 1.5 mg | Antihyperglycaemics except DPP4is or GLP‐1 RAs | −0.61 [−0.65; −0.58]; <.0001 (at 5 months' follow‐up) | −1.46 [−1.67; −1.25]; <.0001 (at 5 months' follow‐up) |
Placebo | ||||
DURATION‐NEO‐2 26 , 28 weeks | Exenatide ER AI 2 mg | Metformin | −0.72 [−1.15; −0.30]; .001 | −1.3 [−2.3; −0.2]; .020 |
Placebo | ||||
DURATION‐7 27 , 28 weeks | Exenatide ER 2 mg | Metformin ± insulin glargine | −0.7 [−0.9; −0.5]; <.001 | −1.5 [−2.1; −0.8]; <.001 |
Placebo | ||||
EXSCEL 28 (median follow‐up 3.2 years) | Exenatide ER 2 mg | Non‐incretin‐based therapies | −0.53 [−0.57; −0.50]; <0.001 | −1.27 [−1.40; −1.13]; <.001 |
Placebo | ||||
SUSTAIN 1 8 , 30 weeks | Semaglutide s.c. 0.5 mg | Metformin, OADs (excluding GLP‐1 RAs or DDP4is) | −1.43 [−1.71; −1.51]; <.0001 | −2.75 [−3.92; −1.58]; <.0001 |
Semaglutide s.c. 1 mg | −1.53 [−1.81; −1.25]; <.0001 | −3.56 [−4.74; −2.38]; <.0001 | ||
Placebo | ||||
SUSTAIN 5 29 , 30 weeks | Semaglutide s.c. 0.5 mg | Basal insulin ± metformin | −1.35 [−1.61; −1.50]; <.0001 | −2.31 [−3.33; −1.29]; <.0001 |
Semaglutide s.c. 1 mg | −1.75 [−2.01; −1.50]; <.0001 | −5.06 [ −6.08; −4.04]; <.0001 | ||
Placebo | ||||
SUSTAIN 6 6 (median follow‐up 2.1 years) | Semaglutide s.c. 0.5 mg | Non‐incretin‐based therapies | −0.66 [−0.80; −0.52]; .0001 | −2.87 [−3.47; −2.28]; <.0001 |
Semaglutide s.c. 1 mg | −1.05 [−1.19; −0.91]; <.0001 | −4.35 [−4.94; −3.75]; <.0001 | ||
Placebo |
Abbreviations: BID, twice‐daily; CI, confidence interval; ETD, estimated treatment difference; exenatide ER, exenatide extended‐release; exenatide ER AI, exenatide ER auto‐injectable; GLP‐1 RA, glucagon‐like peptide‐1 receptor agonist; HbA1c, glycated haemoglobin; NR, not recorded; NS, non‐significant; QW, once‐weekly; s.c., subcutaneous.
ETD compared with exenatide BID treatment arm.