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,* % | 51.8 | 24.0 | 3.4 (2.2; 5.3) | <0.0001 |
| Secondary confirmatory end points | ||||
| Proportion of individuals achieving >10% weight loss,* % | 22.8 | 6.6 | 4.2 (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 baseline | 2.7 | 2.3 | 0.4 (−1.0; 1.8) | 0.5716 |
| Change in IWQOL-Lite for CT physical function domain score from baseline | 8.2 | 5.7 | 2.5 (−1.5; 6.4) | 0.2218 |
| Secondary supportive end points | ||||
| Change in total daily insulin dose from baseline, units | 2.8 | 17.8 | −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* | 39.0 | 13.9 | 3.9 (2.4; 6.5) | <0.0001 |
| Individuals achieving ≥5% weight loss, HbA1c <7%, and no documented symptomatic hypoglycemia at week 56* | 17.8 | 6.2 | 3.3 (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 cholesterol† | 0.97 | 1.01 | 0.97 (0.94; 1.00) | 0.0463 |
| LDL cholesterol† | 0.97 | 1.01 | 0.96 (0.91; 1.01) | 0.1027 |
| HDL cholesterol† | 1.04 | 1.02 | 1.02 (0.99; 1.04) | 0.2778 |
| VLDL cholesterol† | 0.89 | 0.94 | 0.94 (0.88; 1.01) | 0.0830 |
| Triglycerides† | 0.88 | 0.94 | 0.94 (0.87; 1.01) | 0.0715 |
| Free fatty acids† | 0.79 | 0.84 | 0.95 (0.85; 1.07) | 0.3936 |
| . | 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,* % | 51.8 | 24.0 | 3.4 (2.2; 5.3) | <0.0001 |
| Secondary confirmatory end points | ||||
| Proportion of individuals achieving >10% weight loss,* % | 22.8 | 6.6 | 4.2 (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 baseline | 2.7 | 2.3 | 0.4 (−1.0; 1.8) | 0.5716 |
| Change in IWQOL-Lite for CT physical function domain score from baseline | 8.2 | 5.7 | 2.5 (−1.5; 6.4) | 0.2218 |
| Secondary supportive end points | ||||
| Change in total daily insulin dose from baseline, units | 2.8 | 17.8 | −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* | 39.0 | 13.9 | 3.9 (2.4; 6.5) | <0.0001 |
| Individuals achieving ≥5% weight loss, HbA1c <7%, and no documented symptomatic hypoglycemia at week 56* | 17.8 | 6.2 | 3.3 (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 cholesterol† | 0.97 | 1.01 | 0.97 (0.94; 1.00) | 0.0463 |
| LDL cholesterol† | 0.97 | 1.01 | 0.96 (0.91; 1.01) | 0.1027 |
| HDL cholesterol† | 1.04 | 1.02 | 1.02 (0.99; 1.04) | 0.2778 |
| VLDL cholesterol† | 0.89 | 0.94 | 0.94 (0.88; 1.01) | 0.0830 |
| Triglycerides† | 0.88 | 0.94 | 0.94 (0.87; 1.01) | 0.0715 |
| Free fatty acids† | 0.79 | 0.84 | 0.95 (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).