LivingGLP1
parallel randomized trial

NCT03059719

A Randomized, Open, Comparative to the Positive-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects Newly Diagnosed as Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT03059719S000085

Design

Randomized
36
Start year
2015
Treatment
12 weeks
Countries
China
Sponsor
PegBio Co., Ltd. (mixed)
Eligibility
drug naive T2D under 5 years, age 18 to 75, BMI 19 to 35, HbA1c 7 to 10 percent

Conduct and analysis

Blinding
open label
Sequence generation
inadequate
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
completers
Missing data
none

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1exenatide
Exenatide 5 to 10 ug BID
lifestyle: not reported9
A2PEGylated exenatide (PB-119)
PB-119 25 ug QW
lifestyle: not reported9
A3PEGylated exenatide (PB-119)
PB-119 50 ug QW
lifestyle: not reported11

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticExenatide 5 to 10 ug BID
A1
PB-119 25 ug QW
A2
PB-119 50 ug QW
A3
agemean (years)52.1153.2253.55
agesd (years)4.147.076.42
bmimean (kg/m2)26.727.9827.33
bmisd (kg/m2)3.092.592.71
femalen656
hba1cmean (percent)8.568.438.14
hba1csd (percent)0.760.60.84
weightmean (kg)70.4275.8271.38
weightsd (kg)8.9512.968.34

Results

1 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (1 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
12A1change-0.39 percent9not stated; completers; R0008409:Discussion