LivingGLP1
parallel randomized trial

S003076

Design

Randomized
35
Start year
2017
Treatment
24 weeks, follow-up 24 weeks
Countries
Turkey (1 sites)
Sponsor
(non industry)
Eligibility
postmenopausal women 45 to 65, type 2 diabetes on metformin only, HbA1c 7 to 10%, BMI above 30

Conduct and analysis

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

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Exenatide 10 ug subcutaneous twice daily
Exenatide
metformin; lifestyle: not reported1715
A2Insulin glargine
Insulin glargine
metformin; lifestyle: not reported1815

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticExenatide 10 ug subcutaneous twice daily
A1
Insulin glargine
A2
Whole trial
ALL
agemean (years)52.7353.00
agesd (years)4.684.07
bmimean (kg/m2)37.4734.00
bmisd (kg/m2)4.442.91
diabetes durationmean (years)4.936.46
diabetes durationsd (years)4.024.27
femalen30
hba1cmean (percent)8.438.10
hba1csd (percent)0.990.45

Analyses this trial contributes to

Results

6 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (4 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1final7.32 percent1.3015not stated; completers; R0019855:Table 1
24A1percent change percent15not stated; completers; R0019855:Table 1
24A2final7.12 percent0.4715not stated; completers; R0019855:Table 1
24A2percent change percent15not stated; completers; R0019855:Table 1
Discontinuation due to adverse events (1 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 17not stated; randomized; R0019855:Figure 1
Discontinuation due to gastrointestinal adverse events (1 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events1 / 17not stated; randomized; nausea; R0019855:Figure 1