LivingGLP1
parallel randomized trial

S002969

Type 2 diabetes (adults)S002969

Design

Randomized
27
Start year
2018
Treatment
26 weeks, follow-up 52.14 weeks
Countries
United Kingdom (3 sites)
Sponsor
King's Health Partners (industry)
Eligibility
age 18 to 70; BMI 30 to 50; HbA1c 48 to below 97 mmol/mol; T2DM under 10 years; undergoing LAGB

Conduct and analysis

Blinding
double blind
Sequence generation
computer
Allocation concealment
central
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
modified itt
Missing data

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Liraglutide 1.8 mg subcutaneous once daily
Liraglutide 1.8 mg after LAGB
laparoscopic adjustable gastric banding; metformin; lifestyle: standard1312
A2Placebo
Placebo after LAGB
laparoscopic adjustable gastric banding; metformin; lifestyle: standard1413

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticLiraglutide 1.8 mg subcutaneous once daily
A1
Placebo
A2
agemean (years)53.4851.20
agesd (years)8.318.59
blackn52
blackpercent38.514.3
bmimedian (kg/m2)38.9134.76
bmiq1 (kg/m2)35.1832.11
bmiq3 (kg/m2)46.1142.87
diabetes durationmedian (years)43
diabetes durationq1 (years)12
diabetes durationq3 (years)85
femalen1011
femalepercent76.978.6
hba1cmedian (mmol/mol)45.055.0
hba1cq1 (mmol/mol)42.048.0
hba1cq3 (mmol/mol)59.065.0
insulin usen1
metformin usen1314
metformin usepercent100.0100
sbpmedian (mmHg)121.00125.67
sbpq1 (mmHg)111.33123.67
sbpq3 (mmHg)124.67130.00
sglt2i usen2
sglt2i usepercent14.3
waistmedian (cm)121.0113.0
waistq1 (cm)108.0106.0
waistq3 (cm)140.0122.0
weightmedian (kg)101.0103.10
weightq1 (kg)94.387.1
weightq3 (kg)128.5116.0
whiten812
whitepercent61.585.7

Analyses this trial contributes to

Results

64 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (9 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1 vs A2md0.2 mmol/mol-11.3 to 11.6not stated; modified itt; R0010852:Results
26.07A1change mmol/mol12not stated; modified itt; R0010852:Table 2
26.07A2change mmol/mol13not stated; modified itt; R0010852:Table 2
39.11A1change mmol/mol12not stated; modified itt; R0010852:Table 2
39.11A1 vs A2md5.67 mmol/mol-4.14 to 15.47not stated; modified itt; R0010852:Supplement Table 5.3
39.11A2change mmol/mol13not stated; modified itt; R0010852:Table 2
52.14A1change mmol/mol12not stated; modified itt; R0010852:Table 2
52.14A1 vs A2md10.9 mmol/mol1.1 to 20.6not stated; modified itt; R0010852:Results
52.14A2change mmol/mol13not stated; modified itt; R0010852:Table 2
Body weight change in kilograms (diabetes) (9 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1change kg12not stated; modified itt; R0010852:Table 2
26.07A1 vs A2md2.0 kg-4.2 to 8.1not stated; modified itt; R0010852:Results
26.07A2change kg13not stated; modified itt; R0010852:Table 2
39.11A1change kg12not stated; modified itt; R0010852:Table 2
39.11A1 vs A2md4.58 kg-2.25 to 11.41not stated; modified itt; R0010852:Supplement Table 6.3
39.11A2change kg13not stated; modified itt; R0010852:Table 2
52.14A1 vs A2md8.23 kg1.6 to 14.9not stated; modified itt; R0010852:Results
52.14A1change kg12not stated; modified itt; R0010852:Table 2
52.14A2change kg13not stated; modified itt; R0010852:Table 2
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 13not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A1events0 / 13not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A2events0 / 14not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A2events1 / 14not stated; safety; R0010852:Supplementary Clinical Sequelae 1
Level 2 or 3 hypoglycemia (episode rate) (4 lines; O04B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1rate13not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A1rate13not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A2rate14not stated; safety; R0010852:Supplementary Clinical Sequelae 1
A2rate14not stated; safety; R0010852:Supplementary Clinical Sequelae 1
Systolic blood pressure change (6 lines; O05)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1change mmHg12not stated; modified itt; R0010852:Supplementary Table 12
26.07A2change mmHg13not stated; modified itt; R0010852:Supplementary Table 12
39.11A1change mmHg12not stated; modified itt; R0010852:Supplementary Table 12
39.11A2change mmHg13not stated; modified itt; R0010852:Supplementary Table 12
52.14A1change mmHg12not stated; modified itt; R0010852:Supplementary Table 12
52.14A2change mmHg13not stated; modified itt; R0010852:Supplementary Table 12
Percent body weight change (9 lines; O10)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1percent change percent12not stated; modified itt; R0010852:Table 2
26.07A1 vs A2md1.24 percent-4.05 to 6.52not stated; modified itt; R0010852:Supplement Table 7.2
26.07A2percent change percent13not stated; modified itt; R0010852:Table 2
39.11A1percent change percent12not stated; modified itt; R0010852:Table 2
39.11A1 vs A2md3.09 percent-3.20 to 9.38not stated; modified itt; R0010852:Supplement Table 7.3
39.11A2percent change percent13not stated; modified itt; R0010852:Table 2
52.14A1percent change percent12not stated; modified itt; R0010852:Table 2
52.14A1 vs A2md6.63 percent-0.35 to 13.60not stated; modified itt; R0010852:Supplement Table 7.4
52.14A2percent change percent13not stated; modified itt; R0010852:Table 2
Physical functioning (any instrument) (4 lines; O24B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1change points12not stated; modified itt; R0010852:Supplementary Table 13
26.07A2change points13not stated; modified itt; R0010852:Supplementary Table 13
52.14A1change points12not stated; modified itt; R0010852:Supplementary Table 13
52.14A2change points13not stated; modified itt; R0010852:Supplementary Table 13
Health related quality of life total score (any instrument) (8 lines; O24C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1change points12not stated; modified itt; R0010852:Supplementary Table 14
26.07A1change points12not stated; modified itt; R0010852:Supplementary Table 13
26.07A2change points13not stated; modified itt; R0010852:Supplementary Table 14
26.07A2change points13not stated; modified itt; R0010852:Supplementary Table 13
52.14A1change points12not stated; modified itt; R0010852:Supplementary Table 14
52.14A1change points12not stated; modified itt; R0010852:Supplementary Table 13
52.14A2change points13not stated; modified itt; R0010852:Supplementary Table 14
52.14A2change points13not stated; modified itt; R0010852:Supplementary Table 13
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events5 / 13not stated; randomized; R0010852:Results
A2events0 / 14not stated; randomized; R0010852:Table 3
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events6 / 13not stated; randomized; R0010852:Table 3
A2events0 / 14not stated; randomized; R0010852:Table 3
Vomiting (1 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 13not stated; randomized; R0010852:Table 3
Diarrhea (1 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 13not stated; randomized; R0010852:Table 3
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 13not stated; randomized; R0010852:Table 3
A2events0 / 14not stated; randomized; R0010852:Table 3
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 13not stated; randomized; abdominal pain; R0010852:Discussion
A2events0 / 14not stated; randomized; R0010852:Table 3
Gallbladder and biliary disease (1 lines; O28)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 13not stated; randomized; cholecystitis; R0010852:Table 3