LivingGLP1
parallel randomized trial

S003041

Design

Randomized
35
Start year
2014
Treatment
2 weeks, follow-up 2 weeks
Countries
Japan (2 sites)
Sponsor
Nippon Boehringer Ingelheim and Eli Lilly (industry)
Eligibility
Japanese; age 40 to 70; BMI below 30; HbA1c 6.0 to 8.5 percent

Conduct and analysis

Blinding
open label
Sequence generation
computer
Allocation concealment
central
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
per protocol
Missing data

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Linagliptin
Linagliptin 5 mg
lifestyle: not reported1815
A2Liraglutide 0.6 mg subcutaneous once daily
Liraglutide 0.6 mg
lifestyle: not reported1714

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticLinagliptin
A1
Liraglutide 0.6 mg subcutaneous once daily
A2
agemean (years)58.5657.76
agesd (years)7.817.63
bmimean (kg/m2)23.8223.98
bmisd (kg/m2)2.293.15
diabetes durationmean (years)4.003.59
diabetes durationsd (years)3.665.73
femalen55
hba1cmean (percent)7.387.21
hba1csd (percent)0.710.59
other oad usepercent00
sbpmean (mmHg)130.44128.24
sbpsd (mmHg)10.999.26
waistmean (cm)86.7987.46
waistsd (cm)8.8610.85

Analyses this trial contributes to

Results

11 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; full analysis; R0020035:Results
A2events0 / 17not stated; full analysis; R0020035:Results
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; randomized; R0020035:Supplement Figure S1
A2events0 / 17not stated; randomized; R0020035:Supplement Figure S1
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; full analysis; R0020035:Results
A2events1 / 17not stated; full analysis; R0020035:Results
Vomiting (1 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; full analysis; R0020035:Results
Diarrhea (1 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; full analysis; R0020035:Results
Constipation (1 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; full analysis; R0020035:Results
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 18not stated; randomized; R0020035:Supplement Figure S1
A2events0 / 17not stated; randomized; R0020035:Supplement Figure S1