LivingGLP1
parallel randomized trial

GetGoal-M-Asia

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period

Type 2 diabetes (adults)NCT01169779S001185

Design

Randomized
391
Start year
2010
Treatment
24 weeks
Countries
Sponsor
Sanofi (industry)
Eligibility
Asian adults with type 2 diabetes on metformin with or without sulfonylurea

Conduct and analysis

Blinding
double blind
Sequence generation
not reported
Allocation concealment
not reported
Outcome adjudication
not reported
Primary estimand
while on treatment
Analysis population
modified itt
Missing data
LOCF

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Placebo
Placebo
metformin with or without sulfonylurea; lifestyle: not reported195188
A2Lixisenatide 20 ug subcutaneous once daily
Lixisenatide 20 ug
metformin with or without sulfonylurea; lifestyle: not reported196185

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticPlacebo
A1
Lixisenatide 20 ug subcutaneous once daily
A2
agemean (years)55.154.5
agesd (years)10.510.3
asiann194196
bmimean (kg/m2)27.0826.75
bmisd (kg/m2)3.753.86
diabetes durationmean (years)6.846.45
diabetes durationsd (years)4.804.64
femalen10395
hba1cmean (percent)7.857.95
hba1csd (percent)0.710.81
other metformin dosemean (mg/day)1363.41369.9
other sulfonylurea usen9282
weightmean (kg)72.7473.18
weightsd (kg)13.6413.93

Analyses this trial contributes to

Results

22 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1change-0.47 percent0.104188while on treatment; modified itt; registry:outcomes
24A2change-0.83 percent0.102185while on treatment; modified itt; registry:outcomes
24A2 vs A1md-0.36 percent-0.551 to -0.162while on treatment; modified itt; registry:outcomes
Body weight change in kilograms (diabetes) (2 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1change-1.24 kg0.273191while on treatment; modified itt; registry:outcomes
24A2change-1.50 kg0.267188while on treatment; modified itt; registry:outcomes
HbA1c below 7 percent (5 lines; O03)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1responders84 / 188not stated; modified itt; R0021439:Table 5
24A1 vs A2or0.590.39 to 0.89not stated; modified itt; R0021439:Table 5
24A1responders38.8 percent188while on treatment; modified itt; registry:outcomes
24A2responders53.0 percent185while on treatment; modified itt; registry:outcomes
24A2responders107 / 185not stated; modified itt; R0021439:Table 5
Level 2 or 3 hypoglycemia (participants) (2 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 194not stated; safety; registry:outcomes
A2events0 / 196not stated; safety; registry:outcomes
Weight loss of 5 percent or more (2 lines; O11A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1responders14.7 percent191while on treatment; modified itt; registry:outcomes
24A2responders19.7 percent188while on treatment; modified itt; registry:outcomes
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events4 / 194not stated; safety; registry:adverse_events
A2events3 / 196not stated; safety; registry:adverse_events
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events3 / 195not stated; randomized; registry:flow
A2events11 / 196not stated; randomized; registry:flow
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events5 / 194not stated; safety; registry:adverse_events
A2events32 / 196not stated; safety; registry:adverse_events
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 194not stated; safety; registry:adverse_events
A2events15 / 196not stated; safety; registry:adverse_events