LivingGLP1
parallel randomized trial

NCT00381342

Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

Type 2 diabetes (adults)NCT00381342S000320

Design

Randomized
233
Start year
2006
Treatment
24 weeks, follow-up 24 weeks
Countries
United States, Puerto Rico, Romania, Russia, India (23 sites)
Sponsor
AstraZeneca (industry)
Eligibility
age over 18; BMI 25 to 45; HbA1c 6.5 to 10.0 percent; antidiabetic drug naive on diet and exercise

Conduct and analysis

Blinding
double blind
Sequence generation
computer
Allocation concealment
central
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
modified itt
Missing data
LOCF

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Exenatide 5 ug subcutaneous twice daily
Exenatide 5 ug BID
none (drug naive; diet and exercise); lifestyle: none7777
A2Exenatide 10 ug subcutaneous twice daily
Exenatide 10 ug BID
none (drug naive; diet and exercise); lifestyle: none7878
A3Placebo
Placebo
none (drug naive; diet and exercise); lifestyle: none7877

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticExenatide 5 ug subcutaneous twice daily
A1
Exenatide 10 ug subcutaneous twice daily
A2
Placebo
A3
agemax (years)727773
agemean (years)545553
agemin (years)283326
agesd (years)10109
asianpercent292327
blackpercent044
bmimean (kg/m2)323132
bmisd (kg/m2)555
diabetes durationmean (years)221
diabetes durationsd (years)332
femalepercent483845
hba1cmean (percent)7.97.87.8
hba1csd (percent)1.01.00.9
hispanicpercent613
sbpmean (mmHg)129130129
sbpsd (mmHg)111212
weightmean (kg)858686
weightsd (kg)151616
whitepercent657266

Results

50 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
HbA1c change (3 lines; O01)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1change-0.7 percent0.176not stated; modified itt; R0027392:Results
24A2change-0.9 percent0.176not stated; modified itt; R0027392:Results
24A3change-0.2 percent0.175not stated; modified itt; R0027392:Results
Body weight change in kilograms (diabetes) (3 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1change-2.8 kg0.377not stated; modified itt; R0027392:Results
24A2change-3.1 kg0.376not stated; modified itt; R0027392:Results
24A3change-1.4 kg0.376not stated; modified itt; R0027392:Results
HbA1c below 7 percent (6 lines; O03)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1responders42 / 76not stated; modified itt; R0027392:Results
24A1responders27 / 56not stated; other; R0027392:Results
24A2responders44 / 76not stated; modified itt; R0027392:Results
24A2responders26 / 56not stated; other; R0027392:Results
24A3responders31 / 75not stated; modified itt; R0027392:Results
24A3responders17 / 59not stated; other; R0027392:Results
Level 2 or 3 hypoglycemia (participants) (6 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Results
A1events4 / 77not stated; modified itt; R0027392:Table II
A2events3 / 78not stated; modified itt; R0027392:Table II
A2events0 / 78not stated; modified itt; R0027392:Results
A3events0 / 77not stated; modified itt; R0027392:Results
A3events1 / 77not stated; modified itt; R0027392:Table II
Level 2 or 3 hypoglycemia (episode rate) (6 lines; O04B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1rate0.2177not stated; modified itt; R0027392:Results
A1rate77not stated; modified itt; R0027392:Results
A2rate0.5278not stated; modified itt; R0027392:Results
A2rate78not stated; modified itt; R0027392:Results
A3rate77not stated; modified itt; R0027392:Results
A3rate0.0377not stated; modified itt; R0027392:Results
Systolic blood pressure change (3 lines; O05)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
24A1change-3.7 mmHg1.2not stated; modified itt; R0027392:Results
24A2change-3.7 mmHg1.2not stated; modified itt; R0027392:Results
24A3change-0.3 mmHg1.2not stated; modified itt; R0027392:Results
All cause mortality (3 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Results
A2events0 / 78not stated; modified itt; R0027392:Results
A3events0 / 77not stated; modified itt; R0027392:Results
Discontinuation due to adverse events (5 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Results
A2events2 / 78not stated; modified itt; R0027392:Results
A2events1 / 78not stated; modified itt; headache; R0027392:Results
A2events1 / 78not stated; modified itt; nausea; R0027392:Results
A3events0 / 77not stated; modified itt; R0027392:Results
Nausea (3 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 77not stated; modified itt; R0027392:Table II
A2events10 / 78not stated; modified itt; R0027392:Table II
A3events0 / 77not stated; modified itt; R0027392:Table II
Vomiting (3 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events3 / 77not stated; modified itt; R0027392:Table II
A2events3 / 78not stated; modified itt; R0027392:Table II
A3events0 / 77not stated; modified itt; R0027392:Table II
Diarrhea (3 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Table II
A2events2 / 78not stated; modified itt; R0027392:Table II
A3events0 / 77not stated; modified itt; R0027392:Table II
Discontinuation due to gastrointestinal adverse events (3 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Results
A2events1 / 78not stated; modified itt; nausea; R0027392:Results
A3events0 / 77not stated; modified itt; R0027392:Results
Death by suicide (3 lines; O35B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 77not stated; modified itt; R0027392:Results
A2events0 / 78not stated; modified itt; R0027392:Results
A3events0 / 77not stated; modified itt; R0027392:Results