Table 2

Key outcomes by treatment group

Overall value at baseline, mean (SD)*Change from baseline at week 56, LSM (SE)Estimated treatment difference [95% CI]P value
Semaglutide 1.0 mgExenatide ER 2.0 mg
HbA1c, %8.3 (0.95)−1.5 (0.06)−0.9 (0.06)−0.62 [–0.80, –0.44]<0.0001
HbA1c, mmol/mol67.7 (10.4)−16.8 (0.68)−10.0 (0.70)−6.78 [–8.70, –4.86]<0.0001
FPG, mmol/L10.5 (2.7)−2.8 (0.13)−2.0 (0.14)−0.84 [–1.21, –0.47]<0.0001
7-Point SMPG, mmol/L
 Mean10.9 (2.5)−2.2 (0.10)−1.5 (0.10)−0.73 [–1.02, –0.44]<0.0001
 Increment2.2 (1.9)−0.6 (0.07)−0.3 (0.07)−0.24 [–0.44, –0.04]0.0189
Body weight, kg95.8 (21.5)−5.6 (0.29)−1.9 (0.29)−3.78 [–4.58, –2.98]<0.0001
BMI, kg/m233.8 (6.7)−2.0 (0.10)−0.6 (0.10)−1.36 [–1.64, –1.07]<0.0001
Waist circumference, cm111.2 (14.5)−5.1 (0.31)−2.3 (0.32)−2.76 [–3.63, –1.89]<0.0001
Blood pressure, mmHg
 Systolic133.5 (14.5)−4.6 (0.68)−2.2 (0.70)−2.37 [–4.29, –0.45]0.0158
 Diastolic79.9 (8.7)−1.0 (0.45)−0.1 (0.46)−0.90 [–2.16, 0.36]0.1616
Pulse rate, bpm75.1 (10.5)2.1 (0.44)1.1 (0.44)1.03 [−0.19, 2.25]0.0973
Subjects achieving target at week 56,‡ n (%)
HbA1c targets
 <7.0% (<53 mmol/mol)270 (67)161 (40)<0.0001
 ≤6.5% (≤48 mmol/mol)190 (47)89 (22)<0.0001
HbA1c target <7.0% (<53 mmol/mol) without severe or BG-confirmed hypoglycemia and no weight gain at week 56226 (56)113 (28)<0.0001
Body weight reduction
 ≥5%212 (52)70 (17)<0.0001
 ≥10%86 (21)18 (4)<0.0001
  • Values are observed means, or observed proportions, based on “on treatment without rescue medication” data from subjects in the full analysis set, with the exception of pulse rate values, which are based on “on-treatment” data from subjects in the safety analysis set. LSM, least squares mean.

  • *Baseline values are for the entire trial population.

  • P values are two-sided, testing the null hypothesis of no treatment difference. ‡For the proportions of subjects achieving targets at week 56, missing data were imputed from a mixed model for repeated measurements and subsequently classified. Severe hypoglycemia was based on the ADA classification. BG-confirmed hypoglycemia was defined as plasma glucose <3.1 mmol/L (56 mg/dL).