LivingGLP1
parallel randomized trial

S003004

Design

Randomized
134
Start year
2020
Treatment
26.07 weeks, follow-up 26.07 weeks
Countries
China (1 sites)
Sponsor
(non industry)
Eligibility
age 18 to 65; BMI 22 to 40; HbA1c 7 to 10 percent on metformin alone

Conduct and analysis

Blinding
not reported
Sequence generation
not reported
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
completers
Missing data
mean imputation

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Beinaglutide flexible dose injection three times daily
Beinaglutide plus metformin
metformin; lifestyle: not reported6749
A2Premixed insulin
Aspart 30 plus metformin
metformin; lifestyle: not reported6752

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticBeinaglutide flexible dose injection three times daily
A1
Premixed insulin
A2
agemean (years)52.151.8
agesd (years)9.28.3
bmimean (kg/m2)27.0826.87
bmisd (kg/m2)3.642.94
hba1cmedian (percent)9.459.60
hba1cq1 (percent)7.708.10
hba1cq3 (percent)11.2211.91
waistmean (cm)98.1597.44
waistsd (cm)9.678.29
weightmean (kg)84.3483.12
weightsd (kg)13.8616.09

Analyses this trial contributes to

Results

8 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (2 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1final percent49not stated; completers; R0016204:Table 2
26.07A2final percent52not stated; completers; R0016204:Table 2
Body weight change in kilograms (diabetes) (2 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
26.07A1final79.30 kg12.9249not stated; completers; R0016204:Table 2
26.07A2final85.39 kg15.9452not stated; completers; R0016204:Table 2
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 67not stated; safety; R0016204:Discussion
A1events0 / 67not stated; safety; R0016204:Discussion
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events4 / 67not stated; randomized; R0016204:Figure 1
A2events2 / 67not stated; randomized; R0016204:Figure 1