Table 2

Change in primary and secondary end points from baseline to week 56: treatment policy estimand

Liraglutide 3.0 mg (n = 198)Placebo (n = 198)ETD/OR* (95% CI)P value
Primary end points
 Change in body weight from baseline, %−5.8−1.5−4.3 (−5.5; −3.2)<0.0001
 Proportion of individuals achieving ≥5% weight loss,* %51.824.03.4 (2.2; 5.3)<0.0001
Secondary confirmatory end points
 Proportion of individuals achieving >10% weight loss,* %22.86.64.2 (2.2; 8.2)<0.0001
 Change in waist circumference from baseline, cm−5.3−2.6−2.7 (−3.9; −1.5)<0.0001
 Change in HbA1c from baseline, %−1.1−0.6−0.5 (−0.8; −0.3)<0.0001
 Change in HbA1c from baseline, mmol/mol−11.9−6.0−5.8 (−8.3; −3.4)<0.0001
 Change in FPG from baseline, mmol/L−1.0−0.6−0.4 (−0.9; 0.1)0.1502
 Change in FPG from baseline, mg/dL−18.4−11.5−6.9 ( −16.4; 2.5)0.1502
 Change in SF-36 physical functioning score from baseline2.72.30.4 (−1.0; 1.8)0.5716
 Change in IWQOL-Lite for CT physical function domain score from baseline8.25.72.5 (−1.5; 6.4)0.2218
Secondary supportive end points
 Change in total daily insulin dose from baseline, units2.817.8−15.0 (−22.0; −8.0)<0.0001
 Change in mean daytime glucose value from baseline, mmol/L−2.2−1.5−0.7 (−1.1; −0.2)0.0032
 Change in mean daytime glucose value from baseline, mg/dL−39.6−27.3−12.4 (−20.6; −4.1)0.0032
 Individuals achieving ≥5% weight loss and HbA1c <7% at week 56*39.013.93.9 (2.4; 6.5)<0.0001
 Individuals achieving ≥5% weight loss, HbA1c <7%, and no documented symptomatic hypoglycemia at week 56*17.86.23.3 (1.66; 6.48)0.0006
 Change in systolic blood pressure from baseline, mmHg−5.6−1.6−4.0 (−6.4; −1.5)0.0014
 Change in diastolic blood pressure from baseline, mmHg−2.3−0.9−1.4 (−3.0; 0.2)0.0905
 Total cholesterol0.971.010.97 (0.94; 1.00)0.0463
 LDL cholesterol0.971.010.96 (0.91; 1.01)0.1027
 HDL cholesterol1.041.021.02 (0.99; 1.04)0.2778
 VLDL cholesterol0.890.940.94 (0.88; 1.01)0.0830
 Triglycerides0.880.940.94 (0.87; 1.01)0.0715
 Free fatty acids0.790.840.95 (0.85; 1.07)0.3936
  • Baseline to week 56 vs. placebo. Full analysis set. Statistical analysis is ANCOVA with jump-to-reference multiple imputation.

  • * The end point is analyzed in a logistic regression model.

  • Data are treatment ratios (liraglutide 3.0 mg/placebo).