Table 5.
Trial name, time until primary endpoint | Treatment arms | Permitted concomitant treatments | ETD HbA1c, % [95% CI]; P‐value | ETD body weight, kg [95% CI]; P‐value |
---|---|---|---|---|
QW GLP‐1 RAs vs insulin (ETD vs insulin) | ||||
AWARD‐2 78 , 52 weeks | Dulaglutide 0.75 mg | Metformin, glimepiride | −0.13 [−0.29; −0.02]; <.001 | −1.33 ± 0.24 a ; <.001 |
Dulaglutide 1.5 mg | −0.45 [−0.60; −0.29]; <.001 | −1.87 ± 0.24 a ; <.001 | ||
Insulin glargine | 1.44 ± 0.24 | |||
AWARD‐4 50 , 26 weeks | Dulaglutide 0.75 mg | Metformin, insulin lispro | −0.17 [−0.33; −0.02]; .015 | 0.18 [−0.35; 0.71] a , b ; <.0001 |
Dulaglutide 1.5 mg | −0.22 [−0.38; −0.07]; .005 | −0.87 [−1.40; −0.34] a , b ; <.0001 | ||
Insulin glargine | 2.33 [1.80, 2.86] b ; <.0001 | |||
AWARD‐7 9 , 26 weeks | Dulaglutide 0.75 mg | Insulin lispro | 0.02 [−0.18; 0.22]; .0001 c | NR |
Dulaglutide 1.5 mg | −0.05 [−0.26; 0.15]; .0001 c | NR | ||
Insulin glargine | ||||
DURATION‐3 79 , 156 weeks | Exenatide ER 2 mg | Metformin ± SUs | −0.20 [−0.39; −0.02]; .03 | −4.51 [−5.23; −3.79]; <.001 |
Insulin glargine | ||||
SUSTAIN 4 80 , 30 weeks | Semaglutide s.c. 0.5 mg | Metformin ± SUs | −0.38 [−0.52; −0.24]; <.0001 | −4.62 [−5.27; −3.96]; <.0001 |
Semaglutide s.c. 1 mg | −0.81 [−0.96; −0.67]; <.0001 | −6.33 [−7.00; −5.68]; <.0001 | ||
Insulin glargine | ||||
QW GLP‐1 RAs in combination with insulin (ETD vs 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 | ||||
DURATION‐7 27 , 28 weeks | Exenatide ER 2 mg | Insulin glargine ± (metformin ± SU) | −0.73 [−0.93; −0.53]; <.001 | −1.5 [−2.17; −0.84]; <.001 |
Placebo | ||||
SUSTAIN 5 29 , 30 weeks | Semaglutide s.c. 0.5 mg | Basal insulin ± metformin | −1.35 [−1.61; −1.10]; <.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 |
Abbreviations: BID, twice‐daily; CI, confidence interval; ETD, estimated treatment difference; exenatide ER AI, exenatide ER auto‐injectable; exenatide ER, exenatide extended‐release; GLP‐1 RA, glucagon‐like peptide‐1 receptor agonist; HbA1c, glycated haemoglobin; NR, not reported; QD, once‐daily; QW, once‐weekly; s.c., subcutaneous; SU, sulphonylurea.
P‐values represent dulaglutide versus insulin glargine.
Adjusted mean change from baseline [95% CI].
Significance for non‐inferiority; †compared against placebo.