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 mg . | Exenatide 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/mol | 67.7 (10.4) | −16.8 (0.68) | −10.0 (0.70) | −6.78 [–8.70, –4.86] | <0.0001 | |
| FPG, mmol/L | 10.5 (2.7) | −2.8 (0.13) | −2.0 (0.14) | −0.84 [–1.21, –0.47] | <0.0001 | |
| 7-Point SMPG, mmol/L | ||||||
| Mean | 10.9 (2.5) | −2.2 (0.10) | −1.5 (0.10) | −0.73 [–1.02, –0.44] | <0.0001 | |
| Increment | 2.2 (1.9) | −0.6 (0.07) | −0.3 (0.07) | −0.24 [–0.44, –0.04] | 0.0189 | |
| Body weight, kg | 95.8 (21.5) | −5.6 (0.29) | −1.9 (0.29) | −3.78 [–4.58, –2.98] | <0.0001 | |
| BMI, kg/m2 | 33.8 (6.7) | −2.0 (0.10) | −0.6 (0.10) | −1.36 [–1.64, –1.07] | <0.0001 | |
| Waist circumference, cm | 111.2 (14.5) | −5.1 (0.31) | −2.3 (0.32) | −2.76 [–3.63, –1.89] | <0.0001 | |
| Blood pressure, mmHg | ||||||
| Systolic | 133.5 (14.5) | −4.6 (0.68) | −2.2 (0.70) | −2.37 [–4.29, –0.45] | 0.0158 | |
| Diastolic | 79.9 (8.7) | −1.0 (0.45) | −0.1 (0.46) | −0.90 [–2.16, 0.36] | 0.1616 | |
| Pulse rate, bpm | 75.1 (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 56 | 226 (56) | 113 (28) | <0.0001 | |||
| Body weight reduction | ||||||
| ≥5% | 212 (52) | 70 (17) | <0.0001 | |||
| ≥10% | 86 (21) | 18 (4) | <0.0001 | |||
| . | Overall value at baseline, mean (SD)* . | Change from baseline at week 56, LSM (SE) . | Estimated treatment difference [95% CI] . | P value† . | ||
|---|---|---|---|---|---|---|
| Semaglutide 1.0 mg . | Exenatide 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/mol | 67.7 (10.4) | −16.8 (0.68) | −10.0 (0.70) | −6.78 [–8.70, –4.86] | <0.0001 | |
| FPG, mmol/L | 10.5 (2.7) | −2.8 (0.13) | −2.0 (0.14) | −0.84 [–1.21, –0.47] | <0.0001 | |
| 7-Point SMPG, mmol/L | ||||||
| Mean | 10.9 (2.5) | −2.2 (0.10) | −1.5 (0.10) | −0.73 [–1.02, –0.44] | <0.0001 | |
| Increment | 2.2 (1.9) | −0.6 (0.07) | −0.3 (0.07) | −0.24 [–0.44, –0.04] | 0.0189 | |
| Body weight, kg | 95.8 (21.5) | −5.6 (0.29) | −1.9 (0.29) | −3.78 [–4.58, –2.98] | <0.0001 | |
| BMI, kg/m2 | 33.8 (6.7) | −2.0 (0.10) | −0.6 (0.10) | −1.36 [–1.64, –1.07] | <0.0001 | |
| Waist circumference, cm | 111.2 (14.5) | −5.1 (0.31) | −2.3 (0.32) | −2.76 [–3.63, –1.89] | <0.0001 | |
| Blood pressure, mmHg | ||||||
| Systolic | 133.5 (14.5) | −4.6 (0.68) | −2.2 (0.70) | −2.37 [–4.29, –0.45] | 0.0158 | |
| Diastolic | 79.9 (8.7) | −1.0 (0.45) | −0.1 (0.46) | −0.90 [–2.16, 0.36] | 0.1616 | |
| Pulse rate, bpm | 75.1 (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 56 | 226 (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).