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Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT01175473
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : October 11, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Lixisenatide (AVE0010)
Device: Pen auto-injector
Drug: Liraglutide
Device: Pre-filled pen injector
Drug: Metformin
Enrollment 148
Recruitment Details The study was conducted at 7 centers in Germany between August 03, 2010 and November 18, 2010.
Pre-assignment Details A total of 259 patients were screened of which 111 (42.9%) were screen failures. A total of 148 patients were randomized.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4. 2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
Period Title: Overall Study
Started 77 [1] 71
Safety Population 77 [2] 71
Pharmacodynamic (PD) Population 75 [3] 68
Completed 75 69
Not Completed 2 2
Reason Not Completed
Adverse Event             2             2
[1]
Randomized and treated.
[2]
All patients who were exposed to at least 1 dose, regardless of amount of treatment administered.
[3]
All patients who received at least 1 dose; had baseline and at least 1 post-baseline PD assessment.
Arm/Group Title Lixisenatide Liraglutide Total
Hide Arm/Group Description 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4. 2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4. Total of all reporting groups
Overall Number of Baseline Participants 77 71 148
Hide Baseline Analysis Population Description
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 71 participants 148 participants
60.5  (7.5) 59.7  (8.5) 60.1  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 71 participants 148 participants
Female
28
  36.4%
21
  29.6%
49
  33.1%
Male
49
  63.6%
50
  70.4%
99
  66.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 71 participants 148 participants
Caucasian/White 76 71 147
Black 1 0 1
Area Under Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h)   [1] 
Mean (Standard Deviation)
Unit of measure:  Hour*milligram per deciliter (h*mg/dL)
Number Analyzed 77 participants 71 participants 148 participants
169.41  (84.03) 183.86  (100.89) 176.28  (92.39)
[1]
Measure Description: The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic.
Postprandial Plasma Glucose (PPG) Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  Milligram per deciliter (mg/dL)
Number Analyzed 77 participants 71 participants 148 participants
88.06  (29.31) 88.06  (35.86) 88.06  (32.47)
[1]
Measure Description: PPG excursion was determined on Day -1 (baseline) as the maximum change in PPG from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) until 4 hours later subtracted from pre-meal plasma concentration. PD population was evaluable for this baseline characteristic.
Pro-insulin AUC(0:30-4:30h)   [1] 
Mean (Standard Deviation)
Unit of measure:  Hour*micro international unit/milliliter
Number Analyzed 77 participants 71 participants 148 participants
5.68  (6.25) 6.54  (5.40) 6.09  (5.86)
[1]
Measure Description: The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic.
Insulin AUC(0:30-4:30h)   [1] 
Mean (Standard Deviation)
Unit of measure:  Hour*micro international unit/milliliter
Number Analyzed 77 participants 71 participants 148 participants
99.55  (43.61) 93.24  (57.30) 96.55  (50.50)
[1]
Measure Description: The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic.
C-Peptide AUC(0:30-4:30h)   [1] 
Mean (Standard Deviation)
Unit of measure:  Hour*nanogram per milliliter (h*ng/mL)
Number Analyzed 77 participants 71 participants 148 participants
10.61  (4.44) 9.99  (4.89) 10.31  (4.65)
[1]
Measure Description: The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic.
Glucagon AUC(0:30-4:30h)   [1] 
Mean (Standard Deviation)
Unit of measure:  Hour*picogram per milliliter (h*pg/mL)
Number Analyzed 77 participants 71 participants 148 participants
27.10  (60.54) 16.47  (78.98) 22.05  (69.87)
[1]
Measure Description: The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (8:00 clock time; prior to standardized breakfast [time: 0.5 hours]) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. PD population was evaluable for this baseline characteristic.
Glycosylated Hemoglobin (HbA1c)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 77 participants 71 participants 148 participants
7.20  (0.63) 7.41  (0.81) 7.30  (0.72)
[1]
Measure Description: HbA1c on Day 1 (pre-dose [hour 0]) was the baseline. Number of patients analyzed = 74 and 68 for Lixisenatide and Liraglutide arms, respectively.
Peptide YY3-36 (PYY3-36) Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  Picomole per liter (pmol/L)
Number Analyzed 77 participants 71 participants 148 participants
0.5 h 17.60  (9.46) 17.83  (9.29) 17.71  (9.35)
2.5 h 21.73  (11.83) 21.02  (9.19) 21.40  (10.62)
4.5 h 21.98  (10.74) 20.88  (10.66) 21.46  (10.68)
[1]
Measure Description: PYY3-36 concentration was determined at 0.5 (8:00 clock time; prior to standardized breakfast), 2.5 and 4.5 hours on Day -1 (time-matched baseline). PD population was evaluable for this baseline characteristic.
Obestatin Concentration   [1] 
Mean (Standard Deviation)
Unit of measure:  Nanomole per liter (nmol/L)
Number Analyzed 77 participants 71 participants 148 participants
0.5 h 0.24  (0.12) 0.29  (0.18) 0.26  (0.15)
2.5 h 0.22  (0.11) 0.26  (0.15) 0.24  (0.13)
4.5 h 0.24  (0.12) 0.27  (0.17) 0.25  (0.15)
[1]
Measure Description: Obestatin concentration was determined at 0.5 (8:00 clock time; prior to standardized breakfast), 2.5 and 4.5 hours on Day -1 (time-matched baseline). PD population was evaluable for this baseline characteristic.
1.Primary Outcome
Title Change From Baseline in Area Under the Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h) at Day 28
Hide Description The area under the plasma glucose concentration time curve (GLU-AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast plasma glucose concentration (time: 0.5 hours). GLU-AUC0:30-4:30h on Day -1 was the baseline. Change in GLU-AUC0:30-4:30h = GLU-AUC0:30-4:30h on Day 28 minus GLU-AUC0:30-4:30h on Day -1.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic (PD) population (modified intent-to-treat [mITT] population) included all randomized patients, who received at least 1 dose of lixisenatide or liraglutide, and had both a baseline assessment and at least 1 post-baseline assessment of any pharmacodynamic variable, irrespective of compliance with the study protocol and procedures.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: h*mg/dL
-227.25
(-246.88 to -207.61)
-72.83
(-93.19 to -52.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lixisenatide, Liraglutide
Comments To detect a difference of 100 or 150 h*mg/dL in change from baseline to Day 28 in GLU-AUC(0:30-4:30h) between lixisenatide and liraglutide, 60 patients per group would provide a power of 90% assuming common standard deviation of 170 or 250 h*mg/dL, respectively, with a 2-sided test at 5% significance level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Linear fixed effects model with fixed terms for treatment, study site and GLU-AUC(0:30-4:30h) at baseline as covariate was used (using Statistical Analysis System [SAS®] PROC MIXED procedure).
Method Linear fixed effects model
Comments No alpha adjustment was performed.
Method of Estimation Estimation Parameter Least squares (LS) Mean Difference
Estimated Value -154.42
Confidence Interval (2-Sided) 95%
-180.30 to -128.54
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28
Hide Description PPG excursion was determined on Day -1 (Baseline) and 28 as the maximum change in PPG from time of breakfast start (time: 0.5 hours) until 4 hours later subtracted from pre-meal plasma concentration.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 0.75, 1, 1.5, 2, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-70.43
(-77.83 to -63.03)
-24.93
(-32.57 to -17.29)
3.Secondary Outcome
Title Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28
Hide Description The area under the pro-insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast pro-insulin concentration (time: 0.5 hours). Pro-insulin AUC0:30-4:30h on Day -1 was the baseline. Change in pro-insulin AUC0:30-4:30h = pro-insulin AUC0:30-4:30h on Day 28 minus pro-insulin AUC0:30-4:30h on Day -1.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: hour*micro international unit/milliliter
-1.27
(-2.36 to -0.18)
-2.47
(-3.59 to -1.34)
4.Secondary Outcome
Title Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28
Hide Description The area under the insulin concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast insulin concentration (time: 0.5 hours). Insulin AUC0:30-4:30h on Day -1 was the baseline. Change in insulin AUC0:30-4:30h = insulin AUC0:30-4:30h on Day 28 minus insulin AUC0:30-4:30h on Day -1.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: hour*micro international unit/milliliter
-64.22
(-78.20 to -50.24)
5.34
(-9.16 to 19.84)
5.Secondary Outcome
Title Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28
Hide Description The area under the C-peptide concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast C-peptide concentration (time: 0.5 hours). C-peptide AUC0:30-4:30h on Day -1 was the baseline. Change in C-peptide AUC0:30-4:30h = C-peptide AUC0:30-4:30h on Day 28 minus C-peptide AUC0:30-4:30h on Day -1.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: h*ng/mL
-5.03
(-6.33 to -3.72)
1.04
(-0.31 to 2.39)
6.Secondary Outcome
Title Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28
Hide Description The area under the glucagon concentration time curve (AUC0:30-4:30h) was calculated using the linear trapezoidal rule from time of breakfast start (30 minutes after study drug administration [time: 0.5 hours] on Day 28) to 4 hours after breakfast start (time: 4.5 hours) and corrected by subtracting pre-breakfast glucagon concentration (time: 0.5 hours). Glucagon AUC0:30-4:30h on Day -1 was the baseline. Change in glucagon AUC0:30-4:30h = glucagon AUC0:30-4:30h on Day 28 minus glucagon AUC0:30-4:30h on Day -1.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 1, 1.5, 2.5, 3.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Least Squares Mean (95% Confidence Interval)
Unit of Measure: h*pg/mL
-46.71
(-61.60 to -31.83)
-25.28
(-40.65 to -9.90)
7.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29
Hide Description Change = HbA1c value at Day 29 (24 hours post-dose on Day 28) minus HbA1c value at baseline (pre-dose [Hour 0] on Day 1).
Time Frame Pre-dose (Hour 0) on Day 1 and 29 (that is, 24 hours post-dose on Day 28)
Hide Outcome Measure Data
Hide Analysis Population Description
PD population. Here, number of patients analyzed = patients with post-baseline HbA1c assessment.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 67
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percentage of hemoglobin
-0.32
(-0.40 to -0.24)
-0.45
(-0.54 to -0.37)
8.Secondary Outcome
Title Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28
Hide Description Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched PYY-36 assessment.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Mean (Standard Deviation)
Unit of Measure: pmol/L
Change at Day 28: 0.5 h 0.02  (5.32) -0.79  (6.77)
Change at Day 28: 2.5 h -7.09  (8.38) -3.14  (6.67)
Change at Day 28: 4.5 h -8.33  (6.73) -2.47  (7.66)
9.Secondary Outcome
Title Change From Time-matched Baseline in Obestatin Concentration at Day 28
Hide Description Change was calculated by subtracting time-matched baseline value from Day 28 value. Baseline value was the Day -1 time-matched obestatin assessment.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Mean (Standard Deviation)
Unit of Measure: nmol/L
Change at Day 28: 0.5 h 0.04  (0.09) 0.02  (0.11)
Change at Day 28: 2.5 h 0.03  (0.09) 0.01  (0.11)
Change at Day 28: 4.5 h -0.01  (0.08) -0.01  (0.12)
10.Secondary Outcome
Title Percentages of Patients by Ranges of Oxyntomodulin Levels
Hide Description Percentage of patients with oxyntomodulin level less than or equal to (<=) limit of detection (LOD), above limit of quantification (LOQ) and between LOD and LOQ were reported. The LOD and LOQ values for oxyntomodulin were 70 and 200 picogram per milliliter (pg/mL) respectively.
Time Frame 0.5 (8:00 clock time; prior to standardized breakfast), 2.5, 4.5 hours on Day -1 (baseline), 0.5 (prior to standardized breakfast), 2.5, 4.5 hours post study drug administration on Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD population. Here, 'n' signifies patients with oxyntomodulin assessment at the specified time point.
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description:
1-step initiation regimen of lixisenatide.
2-step initiation regimen of liraglutide.
Overall Number of Participants Analyzed 75 68
Measure Type: Number
Unit of Measure: percentage of participants
Day -1, 0.5 h: <=LOD (n = 75, 68) 33.3 20.6
Day -1, 0.5 h: LOD-LOQ (n = 75, 68) 49.3 55.9
Day -1, 0.5 h: >LOQ (n = 75, 68) 17.3 23.5
Day -1, 2.5 h: <=LOD (n = 75, 68) 12.0 8.8
Day -1, 2.5 h: LOD-LOQ (n = 75, 68) 25.3 23.5
Day -1, 2.5 h: >LOQ (n = 75, 68) 62.7 67.6
Day -1, 4.5 h: <=LOD (n = 75, 68) 17.3 11.8
Day -1, 4.5 h: LOD-LOQ (n = 75, 68) 34.7 39.7
Day -1, 4.5 h: >LOQ (n = 75, 68) 48.0 48.5
Day 28, 0.5 h: <=LOD (n = 75, 68) 38.7 30.9
Day 28, 0.5 h: LOD-LOQ (n = 75, 68) 40.0 51.5
Day 28, 0.5 h: >LOQ (n = 75, 68) 21.3 17.6
Day 28, 2.5 h: <=LOD (n = 74, 68) 52.7 16.2
Day 28, 2.5 h: LOD-LOQ (n = 74, 68) 32.4 48.5
Day 28, 2.5 h: >LOQ (n = 74, 68) 14.9 35.3
Day 28, 4.5 h: <=LOD (n = 75, 68) 52.0 20.6
Day 28, 4.5 h: LOD-LOQ (n = 75, 68) 33.3 52.9
Day 28, 4.5 h: >LOQ (n = 75, 68) 14.7 26.5
Time Frame First dose of study drug up to 3 days after the last dose administration, up to 31 days
Adverse Event Reporting Description Median exposure to study treatment was 28 days in both treatment arms. The analysis was performed on safety population, defined as all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.
 
Arm/Group Title Lixisenatide Liraglutide
Hide Arm/Group Description 1-step initiation regimen of lixisenatide. 2-step initiation regimen of liraglutide.
All-Cause Mortality
Lixisenatide Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lixisenatide Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lixisenatide Liraglutide
Affected / at Risk (%) Affected / at Risk (%)
Total   36/77 (46.75%)   47/71 (66.20%) 
Gastrointestinal disorders     
Abdominal distension * 1  5/77 (6.49%)  9/71 (12.68%) 
Constipation * 1  2/77 (2.60%)  5/71 (7.04%) 
Diarrhoea * 1  2/77 (2.60%)  11/71 (15.49%) 
Dyspepsia * 1  6/77 (7.79%)  12/71 (16.90%) 
Nausea * 1  17/77 (22.08%)  16/71 (22.54%) 
Vomiting * 1  8/77 (10.39%)  5/71 (7.04%) 
General disorders     
Fatigue * 1  5/77 (6.49%)  4/71 (5.63%) 
Infections and infestations     
Nasopharyngitis * 1  3/77 (3.90%)  5/71 (7.04%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  14/77 (18.18%)  26/71 (36.62%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/77 (3.90%)  8/71 (11.27%) 
Nervous system disorders     
Dizziness * 1  1/77 (1.30%)  4/71 (5.63%) 
Headache * 1  9/77 (11.69%)  11/71 (15.49%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Data for "Percentages of patients by ranges of oxyntomodulin levels" was reported instead of "Change from Baseline in oxyntomodulin concentration at Day 28" due to change in planned analysis as there were high numbers of values below the LOD.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-us@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01175473     History of Changes
Other Study ID Numbers: PDY10931
2009-017666-23 ( EudraCT Number )
U1111-1116-9040 ( Other Identifier: UTN )
First Submitted: August 2, 2010
First Posted: August 4, 2010
Results First Submitted: August 18, 2016
Results First Posted: October 11, 2016
Last Update Posted: November 28, 2016