LivingGLP1
parallel randomized trial

NCT02160990

Effect of Exenatide in Obese Patients With Accelerated Gastric Emptying

Design

Randomized
20
Start year
2014
Treatment
4.29 weeks, follow-up 4.29 weeks
Countries
United States (1 sites)
Sponsor
Mayo Clinic (non industry)
Eligibility
Adults; BMI 30 to 40; accelerated gastric emptying; no diabetes

Conduct and analysis

Blinding
double blind
Sequence generation
computer
Allocation concealment
pharmacy or sealed
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
randomized
Missing data
none

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Placebo
Placebo twice daily
lifestyle: none1010
A2Exenatide 5 ug subcutaneous twice daily
Exenatide 5 ug twice daily
lifestyle: none1010

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticPlacebo
A1
Exenatide 5 ug subcutaneous twice daily
A2
agemedian (years)42.534
ageq1 (years)25.333
ageq3 (years)49.546.8
bmimedian (kg/m2)34.233.5
bmiq1 (kg/m2)31.732.9
bmiq3 (kg/m2)38.536.7
femalepercent7060
hispanicpercent1010
waistmedian (cm)108.5107.7
waistq1 (cm)105100
waistq3 (cm)118121
weightmedian (kg)103.498.1
weightq1 (kg)87.689.4
weightq3 (kg)111.9109.7
whitepercent9090

Analyses this trial contributes to

Results

14 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
All cause mortality (2 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 10not stated; randomized; R0020690:Results
A2events0 / 10not stated; randomized; R0020690:Results