Results tables

Results tables

Table 8 Pi-Sunyer et al. 2015

Liraglutide 3.0 mg once daily

Placebo

Analysis

n a

2,437

1,225

Co-primary outcomes

Mean (SD) % change in body weight from baseline to week 56

−8.0% (6.7%)

−2.6% (5.7%)

Estimated treatment difference: −5.4% (95% CI −5.8% to −5.0%); p<0.001

Percentage of participants who lost 5% or more body weight from baseline to week 56

63.2%

27.1%

Estimated treatment difference: 36.1% OR: 4.8 (95% CI 4.1% to 5.6%); p<0.001

Percentage of participants who lost more than 10% body weight from baseline to week 56

33.1%

10.6%

Estimated treatment difference: 22.5% OR: 4.3 (95% CI 3.5% to 5.3%); p<0.001

Selected secondary outcomes

Mean (SD) change in waist circumference from baseline (cm)

−8.2 (7.3)

−3.9 (6.6)

Estimated treatment difference: −4.2 (95% CI −4.7 to −3.7); p<0.001b

Mean (SD) change in BMI from baseline

−3.0 (2.6)

−1.0 (2.3)

Estimated treatment difference: −2.0 (95% CI −2.2 to −1.9); p<0.001b

Mean (SD) change in systolic blood pressure from baseline (mm Hg)

−4.2 (12.2)

−1.5 (12.4)

Estimated treatment difference: −2.8 (95% CI −3.56 to −2.09); p<0.001b

Mean percentage change in fasting total cholesterol from baselinec

−3.1%

−1.0%

Estimated treatment difference: −2.3% (95% CI −3.3% to −1.3%); p<0.001b

Mean (SD) change in IWQOL-Lite total score from baselined

10.6 (13.3)

7.7 (12.8)

Estimated treatment difference: 3.1 (95% CI 2.2 to 4.0); p<0.001b

Safety and tolerability outcomes

n e

2,481

1,242

Participants with an adverse event that occurred in at least 5% of participants

80.3% (1992/2,481)

63.3% (786/1,242)

No statistical analysis reported for safety outcomes

Participants with a severe adverse event that occurred in at least 0.2% of participants

6.2% (154/2,481)

5.0% (62/1,242)

Participants who withdrew from study due to adverse events

9.9% (246/2,487)

3.8% (47/1,244)

Nausea

40.2% (997/2,481)

14.7% (183/1,242)

a Efficacy analyses were based on the full-analysis set, which included all participants who underwent randomisation and received at least 1 dose of the study drug and had at least 1 assessment after baseline.

b No adjustments were made for multiple testing for the secondary analyses. Therefore any statistical analysis provided for these outcomes should be interpreted with caution.

c Standard deviation for this outcome not provided in paper.

d IWQOL-Lite is a validated, 31-item, self-reported measure of obesity-specific quality of life measured in 5 domains (physical function, self-esteem, sexual life, public distress and work). Higher scores indicate better quality of life.

e The safety analysis set included all participants who were randomised to a study drug and received at least 1 dose.

Abbreviations: CI, confidence interval; IWQOL-Lite, impact of weight on quality of life-lite version; OR, odds ratio; SD, standard deviation

Table 9 le Roux et al. 2017

Liraglutide 3.0 mg once daily

Placebo

Analysis

n a

1,472

738

Primary outcome

Time to onset of type 2 diabetesover 160-week study periodb

Number of participants diagnosed with type 2 diabetes: 2% (26/1,472)

Number of participants diagnosed with type 2 diabetes: 6% (46/738)

HR: 0.21 (95% CI 0.13 to 0.34); p<0.0001

Selected secondary outcomes

Mean (SD) % change in body weight from baseline to week 160

−6.1% (7.3%)

− 1.9% (6.3%)

Estimated treatment difference −4.3% (95% CI −4.9% to −3.7%); p<0.0001c

Safety and tolerability outcomes

n d

1501

747

Participants with adverse events

95% (1,421/1,501)

89% (668/747)

No statistical analysis reported for safety outcomes

Participants with serious adverse events

15% (227/1,501)

13% (96/747)

Participants who withdrew from study due to adverse events

13% (199/1,501)

6% (46/747)

a Efficacy analyses were based on the full-analysis set, which included all participants who underwent randomisation, received at least 1 treatment dose and had at least 1 post-baseline assessment.

b Prediabetes was defined as either an HbA1c measurement from 39 to 46 mmol/mol or a fasting plasma glucose measurement from 5.6 to 6.9 mmol per litre or a 2 hour oral glucose tolerance test of 7.8 to 11.0 mmol per litre. At baseline, the mean HbA1c was 40 mmol/mol in the liraglutide group and 39 mmol/mol in the placebo group. A diagnosis of type 2 diabetes was made following 2 consecutive measurements of: a HbA1c of 48 mmol/mol and above, or a fasting plasma glucose concentration of 7.0 mmol per litre and above or a 2 hour oral glucose tolerance test of 11.1 mmol per litre and above.

c No adjustments were made for multiple testing for the secondary analyses. Therefore any statistical analysis provided for these outcomes should be interpreted with caution.

d The safety analysis set included all participants who were randomised to a study drug and received at least 1 dose.

Abbreviations: CI, confidence interval; SD, standard deviation

Table 10 Davies et al. 2015

Liraglutide 3.0 mg once daily

Placebo

Analysis

n a

412

211

Co-primary outcomes

Estimated mean % change in body weight from baseline to week 56

−6.0%

−2.0%

Estimated treatment difference: −4.0% (95% CI −5.1% to −2.9%); p<0.001

Percentage of participants who lost 5% or more body weight from baseline to week 56

54.3%

21.4%

Estimated treatment difference: 32.9% (95% CI 24.6% to 41.2%); p<0.001

Percentage of participants who lost more than 10% body weight from baseline to week 56

25.2%

6.7%

Estimated treatment difference: 18.5% (95% CI 12.7% to 24.4%); p<0.001

Selected secondary outcomes

Percentage of participants with a HbA1c less than 53 mmol/mol after 56 weeks' treatment

69.2% (278/411)

27.2% (56/211)

Estimated treatment difference: 42% OR: 8.79 (95% CI 5.74 to 13.44); p<0.001b

Safety and tolerability outcomes

n c

422

212

Participants with treatment-emergent adverse events

92.9% (392/422)

85.8% (182/212)

No statistical analysis reported for safety outcomes

Participants with serious treatment emergent adverse events

8.8% (37/422)

6.1% (13/212)

Participants who withdrew from study due to adverse events

9.2% (39/422)

3.3% (7/212)

Participants with gastrointestinal disorder adverse events

65.2% (275/422)

39.2% (83/212)

a Efficacy analyses were based on the full-analysis set, which included all participants who underwent randomisation and received at least 1 dose of the study drug and had at least 1 assessment after baseline

b The study authors described these secondary outcomes as exploratory. No adjustments were made for multiple testing for the secondary analyses. Therefore any statistical analysis provided for these outcomes should be interpreted with caution.

c The safety analysis set included all participants who were randomised to a study drug and received at least 1 dose

Abbreviations: CI, confidence interval; OR, odds ratio

Table 11 Blackman et al. 2016

Liraglutide 3.0 mg once daily

Placebo

Analysis

n a

180

179

Primary outcome

Mean (SE) change from baseline to week 32 in AHI (events per hour of sleep)b

−12.2 (1.8)

−6.1 (2.0)

Estimated treatment difference: −6.1 (95% CI −11.0 to −1.2); p=0.015

Selected secondary outcomes

Mean (SE) % change in body weight from baseline to week 32

−5.7% (0.4%)

− 1.6% (0.3%)

Estimated treatment difference −4.2% (95% CI −5.2% to −3.1%); p<0.0001c

Safety and tolerability outcomes

n d

176

179

Participants with adverse eventse

80.1%

69.3%

No statistical analysis reported for safety outcomes

Participants with serious adverse events

3.4% (6/176)

3.4% (6/179)

Participants who withdrew from study due to adverse events

11.4% (20/176)

3.4% (6/179)

a Efficacy analyses were based on the full-analysis set, which included all participants who underwent randomisation.

b Change in AHI based on the American Academy of Sleep Medicine's 2007 definition with hypopnea requiring 30% or more reduction in nasal pressure signal excursions from baseline and 4% or more desaturation from pre-event baseline. At baseline, mean (SE) AHI was 49.0 (27.5) apnoea or hypopnea events per hour of sleep in the liraglutide group and 49.3 (27.5) in the placebo group.

c No adjustments were made for multiple testing for the secondary analyses. Therefore any statistical analysis provided for these outcomes should be interpreted with caution.

d The safety analysis set included all participants who were randomised to a study drug and received at least 1 dose.

e Number of participants for this outcome in each group not provided in study paper.

Abbreviations: AHI, apnoea-hypopnea index (apnoea or hypopnea events per hour of sleep); CI, confidence interval; SE, standard error