LivingGLP1
parallel randomized trial

NCT04876027

Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome

Design

Randomized
68
Start year
2021
Treatment
26.07 weeks
Countries
China (1 sites)
Sponsor
Shanghai Tenth People's Hospital (non industry)
Eligibility
women 18 to 45, BMI 24 or higher, PCOS by Rotterdam criteria

Conduct and analysis

Blinding
open label
Sequence generation
computer
Allocation concealment
pharmacy or sealed
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
randomized
Missing data
not reported

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Dulaglutide 1.5 mg subcutaneous once weekly
Dulaglutide 1.5 mg plus calorie restricted diet
calorie restricted diet 1000 to 1300 kcal with dietitian follow up and exercise advice; lifestyle: intensive3535
A2Standard care or no added treatment
Calorie restricted diet alone
calorie restricted diet 1000 to 1300 kcal with dietitian follow up and exercise advice; lifestyle: intensive3333

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticDulaglutide 1.5 mg subcutaneous once weekly
A1
Standard care or no added treatment
A2
agemean (years)30.3128.64
bmimean (kg/m2)29.6829.71
hba1cmean (percent)5.725.64
sbpmean (mmHg)124.14127.69
waistmean (cm)96.7694.89
weightmean (kg)77.6278.84

Analyses this trial contributes to

Results

12 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 35not stated; randomized; R0009547:Table 3
A2events0 / 33not stated; randomized; R0009547:Table 3
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events8 / 35not stated; randomized; R0009547:Table 3
A2events0 / 33not stated; randomized; R0009547:Table 3
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events7 / 35not stated; randomized; R0009547:Table 3
A2events0 / 33not stated; randomized; R0009547:Table 3
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 35not stated; randomized; R0009547:Table 3
A2events0 / 33not stated; randomized; R0009547:Table 3
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events4 / 35not stated; randomized; R0009547:Table 3
A2events0 / 33not stated; randomized; R0009547:Table 3
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 35not stated; randomized; R0009547:Results
A2events0 / 33not stated; randomized; R0009547:Table 3