LivingGLP1
parallel randomized trial

S003030

Design

Randomized
66
Start year
2015
Treatment
52 weeks, follow-up 52 weeks
Countries
China (1 sites)
Sponsor
AstraZeneca China and 3SBio Inc. (industry)
Eligibility
age 20 to 75; HbA1c 7.5 to 11 percent; two or more oral agents for 3 months

Conduct and analysis

Blinding
open label
Sequence generation
computer
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
full analysis
Missing data
MMRM

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Exenatide 10 ug subcutaneous twice daily
Exenatide twice daily
oral glucose lowering drugs except sulfonylureas and nateglinide; lifestyle: standard3327
A2Premixed insulin
Insulin aspart 70/30
oral glucose lowering drugs except sulfonylureas and nateglinide; lifestyle: standard3332

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticExenatide 10 ug subcutaneous twice daily
A1
Premixed insulin
A2
agemean (years)58.8558.03
agesd (years)12.5413.32
bmimean (kg/m2)23.6424.36
bmisd (kg/m2)2.862.52
diabetes durationmean (years)6.597.81
diabetes durationsd (years)5.326.02
femalen818
hba1cmean (percent)8.678.32
hba1csd (percent)1.030.96
sbpmean (mmHg)127.03125.46
sbpsd (mmHg)16.4815.04
weightmean (kg)68.6866.30
weightsd (kg)11.9511.42

Analyses this trial contributes to

Results

11 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
52A1change-1.31 percent1.4227not stated; full analysis; R0018574:Table 2
52A2change-1.09 percent1.4232not stated; full analysis; R0018574:Table 2
Body weight change in kilograms (diabetes) (2 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
52A1change-2.21 kg3.4327not stated; full analysis; R0018574:Table 2
52A2change1.57 kg2.9632not stated; full analysis; R0018574:Table 2
Level 2 or 3 hypoglycemia (participants) (4 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 27not stated; full analysis; R0018574:Results
A1events0 / 27not stated; full analysis; R0018574:Results
A2events0 / 32not stated; full analysis; R0018574:Results
A2events5 / 32not stated; full analysis; R0018574:Results
Systolic blood pressure change (2 lines; O05)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
52A1change-1.85 mmHg14.3527not stated; full analysis; R0018574:Table 2
52A2change2.25 mmHg18.7432not stated; full analysis; R0018574:Table 2
Discontinuation due to adverse events (1 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 33not stated; randomized; R0018574:Figure 1