LivingGLP1
parallel randomized trial

NCT02200991

A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus

Type 2 diabetes (adults)NCT02200991S001003

Design

Randomized
136
Start year
2014
Treatment
4 weeks, follow-up 4.43 weeks
Countries
Japan (15 sites)
Sponsor
Sanofi K.K. (industry)
Eligibility
age 20 to 75; T2D 5 years or more; HbA1c 7.0 to 10.0; FBG 180 mg/dL or less; stable glargine

Conduct and analysis

Blinding
open label
Sequence generation
not reported
Allocation concealment
central
Outcome adjudication
not reported
Primary estimand
not stated
Analysis population
modified itt
Missing data
none stated

Arms

ArmTreatmentBackgroundRandomizedAnalyzedCompleted treatment
A1Lixisenatide 20 ug subcutaneous once daily
Lixisenatide 20 ug plus glargine
insulin glargine with or without sulfonylurea; lifestyle: none696967
A2Sitagliptin
Sitagliptin 50 mg plus glargine
insulin glargine with or without sulfonylurea; lifestyle: none676666

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.
CharacteristicStatisticLixisenatide 20 ug subcutaneous once daily
A1
Sitagliptin
A2
agemean (years)58.558.3
agesd (years)10.19.6
bmimean (kg/m2)24.9926.08
bmisd (kg/m2)4.085.10
diabetes durationmax (years)35.241.1
diabetes durationmedian (years)11.399.82
diabetes durationmin (years)5.65.2
hba1cmean (percent)8.278.32
hba1csd (percent)0.750.80
insulin dosemean (U/day)14.317.0
insulin dosesd (U/day)8.410.7
other background sulfonylurean3332
other background sulfonylureapercent47.847.8
other malen4144
other malepercent59.465.7
weightmean (kg)65.1570.48
weightsd (kg)13.6416.38

Analyses this trial contributes to

Results

24 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Body weight change in kilograms (diabetes) (2 lines; O02)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
4A1change-0.41 kgnot stated; safety; R0024589:Results
4A2change0.39 kgnot stated; safety; R0024589:Results
Level 2 or 3 hypoglycemia (participants) (6 lines; O04)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events7 / 69while on treatment; safety; R0024589:Table 3
A1events11 / 69while on treatment; safety; R0024589:Table 3
A1events0 / 69while on treatment; safety; R0024589:Table 3
A2events1 / 67while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
A2events1 / 67while on treatment; safety; R0024589:Table 3
All cause mortality (2 lines; O20)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Serious adverse events (2 lines; O25)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events0 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Discontinuation due to adverse events (2 lines; O26)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Nausea (2 lines; O27A)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events22 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Vomiting (2 lines; O27B)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events4 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Diarrhea (2 lines; O27C)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events3 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Constipation (2 lines; O27D)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events3 / 69while on treatment; safety; R0024589:Table 3
A2events0 / 67while on treatment; safety; R0024589:Table 3
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
WeekArmStatisticEstimateSE or SD95% CIEvents / NDetail
A1events2 / 69while on treatment; safety; R0024589:Results
A2events0 / 67while on treatment; safety; R0024589:Results