LivingGLP1
parallel randomized trial

NCT00500370

A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients

Design

Randomized
163
Start year
2007
Treatment
24 weeks, follow-up 28 weeks
Countries
Sponsor
Eli Lilly and Company; Amylin Pharmaceuticals (industry)
Eligibility
adults with BMI 30 or more, without diabetes

Conduct and analysis

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

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Exenatide 10 ug subcutaneous twice daily
Exenatide 10 ug BID
none; lifestyle: intensive807348
A2Placebo
Placebo
structured diet and physical activity program; lifestyle: intensive837954

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticExenatide 10 ug subcutaneous twice daily
A1
Placebo
A2
Whole trial
ALL
agemean (years)47.0145.15
agesd (years)10.9512.74
bmimean (kg/m2)39.6439.39
femalen5867
hba1cmean (percent)5.615.58
other igt or ifgn38
other igt or ifgpercent25
weightmean (kg)109.5107.6

Analyses this trial contributes to

Results

18 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (1 lines; O10)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1 vs A2md-3.3 percent0.5not stated; modified itt; R0026955:Results
Weight loss of 5 percent or more (2 lines; O11A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1responders31.573not stated; modified itt; registry:outcomes
24A2responders16.579not stated; modified itt; registry:outcomes
Progression to type 2 diabetes (2 lines; O14)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events3 / 65not stated; modified itt; registry:outcomes
A2events2 / 65not stated; modified itt; registry:outcomes
All cause mortality (2 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 73not stated; modified itt; R0026955:Results
A2events0 / 79not stated; modified itt; R0026955:Results
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 73not stated; safety; registry:adverse_events
A2events0 / 79not stated; safety; registry:adverse_events
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events9 / 80not stated; randomized; registry:flow
A2events3 / 83not stated; randomized; registry:flow
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events18 / 73not stated; safety; registry:adverse_events
A2events3 / 79not stated; safety; registry:adverse_events
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events6 / 73not stated; safety; registry:adverse_events
A2events1 / 79not stated; safety; registry:adverse_events
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events10 / 73not stated; safety; registry:adverse_events
A2events2 / 79not stated; safety; registry:adverse_events
Discontinuation due to gastrointestinal adverse events (1 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events5 / 80not stated; randomized; R0026955:Results