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CompletedNCT01175473Updated Nov 28, 2016Results posted

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

A Phase 2 interventional study of Lixisenatide (AVE0010) and Pen auto-injector in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 7 sites in Germany. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-11-28.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study summary

The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment.

The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose concentration curve (AUC) after a standardized breakfast at Week 4.

The secondary objectives are to assess the effects of lixisenatide on the maximum PPG excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast, 24-hour profile of plasma glucose, glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and oxyntomodulin); and to assess the clinical and laboratory safety profile.

Read the detailed description

The duration of the study for each patient is up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/- 2 days after last study drug administration.

02

Conditions studied

  • Type 2 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 148 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit, not adequately controlled by metformin at a dose of at least 1.5 gram per day for at least 3 months prior to screening
  • HbA1c greater than or equal to (>=) 6.5% (as recommended by the American Diabetes Association) and HbA1c less than or equal to (\<=) 9% at screening
  • Covered by Health Insurance System where applicable and/or in compliance with the recommendations of the National (German) Law in force relating to biomedical research
  • Not under any administrative or legal supervision

Exclusion criteria

Exclusion criteria:

  • At the time of screening age \<18 years or >=75 years
  • Body Mass Index (BMI): \<=20 kilogram per square meter (kg/m\^2) or >=37 kg/m\^2
  • History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
  • Hemoglobinopathy or hemolytic anemia
  • History of myocardial infarction, stroke, or heart failure requiring hospitalization within 6 months prior to the time of screening, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period
  • Cardiovascular, hepatic, neurological, or endocrine disease, active malignant tumor or other major systemic disease or patients with short life expectancy making implementation of the protocol or interpretation of the study results difficult (euthyroid patients on replacement therapy are to be included if the dosage of thyroxin is stable for at least 3 months prior to the screening visit)
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure >160 millimeter of mercury (mmHg) or >95 mmHg, respectively
  • Any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub-investigator precludes safe completion of the study
  • Receipt of blood or plasma products within 3 months prior to the time of screening
  • Investigator or any sub-investigator, pharmacist, study coordinator, or their study staff or relative thereof directly involved in the conduct of the protocol
  • Patients who are considered by the investigator or any sub-investigator as inappropriate for this study for any reason (for example, impossibility of meeting specific protocol requirements such as scheduled visits, being unable to do self-injections, etc.)
  • Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (for example, alpha glucosidase inhibitor, exenatide, dipeptidyl peptidase IV [DPP-IV] inhibitors, insulin, thiazolidinedione, sulfonylurea, etc.) within 3 months prior to the time of screening
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to the time of screening
  • Likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol
  • Use of any investigational drug within 3 months prior to screening
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to, gastroparesis and gastroesophageal reflux disease requiring medical treatment within 6 months prior to the time of screening
  • Any previous treatment with lixisenatide or liraglutide
  • Allergic reaction to any glucagon like peptide - 1 (GLP-1) agonist in the past (for example, exenatide) or to metacresol
  • History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
  • Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
  • Known history of drug or alcohol abuse within 6 months prior to the time of screening
  • Laboratory findings at the time of screening: alanine aminotransferase: >3 times the upper limit of the normal (ULN) laboratory range; calcitonin >=20 picogram per milliliter (pg/mL); amylase and lipase >3 times ULN; total bilirubin >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin \<11 gram/deciliter and/or neutrophils \<1500 per cubic millimeter (mm\^3) and/or platelets \<100,000/mm\^3; positive test for Hepatitis B surface antigen and/or Hepatitis C antibody and Positive reaction to tests for anti-human immunodeficiency virus (HIV) type 1 (HIV1) and anti-HIV2 antibodies
  • Renal impairment defined by creatinine clearance \<60 milliliter per minute (mL/min) using the Cockcroft-Gault formula
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • Experimental
    Lixisenatide

    1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD for up to Week 4.

    Drug: Lixisenatide (AVE0010) · Device: Pen auto-injector · Drug: Metformin

  • Active comparator
    Liraglutide

    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.

    Drug: Liraglutide · Device: Pre-filled pen injector · Drug: Metformin

Interventions

  • DrugLixisenatide (AVE0010)

    Self administered by subcutaneous injections once daily 30 minutes before breakfast.

  • DevicePen auto-injector

    Also known as: OptiClik®

  • DrugLiraglutide

    Self administered by subcutaneous injections once daily 30 minutes before breakfast.

  • DevicePre-filled pen injector

    Also known as: Victoza®

  • DrugMetformin

    Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.

06

What researchers measure

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28

    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

  2. Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28

    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

  3. Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28

    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

  4. Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28

    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

  5. Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28

    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

  6. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29

    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)

  7. Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28

    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

  8. Change From Time-matched Baseline in Obestatin Concentration at Day 28

    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

  9. Percentages of Patients by Ranges of Oxyntomodulin Levels

    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

07

Results

Posted Oct 11, 2016
Limitations and caveats
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.

Participant flow

The study was conducted at 7 centers in Germany between August 03, 2010 and November 18, 2010.

Participant flow — Overall Study
MilestoneLixisenatideLiraglutide
Started7771
Safety population7771
Pharmacodynamic (pd) population7568
Completed7569
Not completed22
Withdrew: Adverse event22

Outcome measures

PrimaryChange 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

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
Reported as:
Least squares mean · h*mg/dL
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
h*mg/dLLixisenatideLiraglutide
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 28-227.25 ± 120.26-72.83 ± 79.66
Statistical analysis
  • Lixisenatide vs Liraglutide · Linear fixed effects model · p = <0.0001 (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).) · Least squares (ls) mean difference: -154.42 · 95% CI -180.30 to -128.54No alpha adjustment was performed.
SecondaryChange From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28

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
Reported as:
Least squares mean · mg/dL
Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28
mg/dLLixisenatideLiraglutide
Change From Baseline in Postprandial Plasma Glucose (PPG) Excursion at Day 28-70.43 ± 42.04-24.93 ± 33.67
SecondaryChange From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28

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
Reported as:
Least squares mean · hour*micro international unit/milliliter
Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28
hour*micro international unit/milliliterLixisenatideLiraglutide
Change From Baseline in Pro-insulin AUC(0:30-4:30h) at Day 28-1.27 ± 6.18-2.47 ± 4.86
SecondaryChange From Baseline in Insulin AUC(0:30-4:30h) at Day 28

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
Reported as:
Least squares mean · hour*micro international unit/milliliter
Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28
hour*micro international unit/milliliterLixisenatideLiraglutide
Change From Baseline in Insulin AUC(0:30-4:30h) at Day 28-64.22 ± 59.745.34 ± 57.82
SecondaryChange From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28

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
Reported as:
Least squares mean · h*ng/mL
Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28
h*ng/mLLixisenatideLiraglutide
Change From Baseline in C-Peptide AUC(0:30-4:30h) at Day 28-5.03 ± 5.971.04 ± 4.71
SecondaryChange From Baseline in Glucagon AUC(0:30-4:30h) at Day 28

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
Reported as:
Least squares mean · h*pg/mL
Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28
h*pg/mLLixisenatideLiraglutide
Change From Baseline in Glucagon AUC(0:30-4:30h) at Day 28-46.71 ± 67.90-25.28 ± 68.07
SecondaryChange From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29

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)
Reported as:
Least squares mean · percentage of hemoglobin
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29
percentage of hemoglobinLixisenatideLiraglutide
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 29-0.32 ± 0.30-0.45 ± 0.40
SecondaryChange From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28

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
Reported as:
Mean · pmol/L
Change From Time-matched Baseline in Peptide YY3-36 (PYY3-36) Concentration at Day 28
pmol/LLixisenatideLiraglutide
Change at Day 28: 0.5 h0.02 ± 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
SecondaryChange From Time-matched Baseline in Obestatin Concentration at Day 28

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
Reported as:
Mean · nmol/L
Change From Time-matched Baseline in Obestatin Concentration at Day 28
nmol/LLixisenatideLiraglutide
Change at Day 28: 0.5 h0.04 ± 0.090.02 ± 0.11
Change at Day 28: 2.5 h0.03 ± 0.090.01 ± 0.11
Change at Day 28: 4.5 h-0.01 ± 0.08-0.01 ± 0.12
SecondaryPercentages of Patients by Ranges of Oxyntomodulin Levels

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
Reported as:
Number · percentage of participants
Percentages of Patients by Ranges of Oxyntomodulin Levels
percentage of participantsLixisenatideLiraglutide
Day -1, 0.5 h: <=LOD (n = 75, 68)33.320.6
Day -1, 0.5 h: LOD-LOQ (n = 75, 68)49.355.9
Day -1, 0.5 h: >LOQ (n = 75, 68)17.323.5
Day -1, 2.5 h: <=LOD (n = 75, 68)12.08.8
Day -1, 2.5 h: LOD-LOQ (n = 75, 68)25.323.5
Day -1, 2.5 h: >LOQ (n = 75, 68)62.767.6
Day -1, 4.5 h: <=LOD (n = 75, 68)17.311.8
Day -1, 4.5 h: LOD-LOQ (n = 75, 68)34.739.7
Day -1, 4.5 h: >LOQ (n = 75, 68)48.048.5
Day 28, 0.5 h: <=LOD (n = 75, 68)38.730.9
Day 28, 0.5 h: LOD-LOQ (n = 75, 68)40.051.5
Day 28, 0.5 h: >LOQ (n = 75, 68)21.317.6
Day 28, 2.5 h: <=LOD (n = 74, 68)52.716.2
Day 28, 2.5 h: LOD-LOQ (n = 74, 68)32.448.5
Day 28, 2.5 h: >LOQ (n = 74, 68)14.935.3
Day 28, 4.5 h: <=LOD (n = 75, 68)52.020.6
Day 28, 4.5 h: LOD-LOQ (n = 75, 68)33.352.9
Day 28, 4.5 h: >LOQ (n = 75, 68)14.726.5

Adverse events

Collected over First dose of study drug up to 3 days after the last dose administration, up to 31 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lixisenatide—0/77 (0%)36/77 (46.8%)
Liraglutide—0/71 (0%)47/71 (66.2%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventLixisenatideLiraglutide
Decreased appetiteMetabolism and nutrition disorders14/7726/71
NauseaGastrointestinal disorders17/7716/71
DyspepsiaGastrointestinal disorders6/7712/71
HeadacheNervous system disorders9/7711/71
DiarrhoeaGastrointestinal disorders2/7711/71
Abdominal distensionGastrointestinal disorders5/779/71
Back painMusculoskeletal and connective tissue disorders3/778/71
VomitingGastrointestinal disorders8/775/71
NasopharyngitisInfections and infestations3/775/71
ConstipationGastrointestinal disorders2/775/71

Baseline characteristics

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
Age, Continuous(years)LixisenatideLiraglutideTotal
Mean60.5 ± 7.559.7 ± 8.560.1 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)LixisenatideLiraglutideTotal
Female282149
Male495099
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)LixisenatideLiraglutideTotal
Caucasian/White7671147
Black101
Area Under Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h)
Area Under Plasma Glucose Concentration Curve From Time 0.5 Hours to 4.5 Hours (GLU-AUC0:30-4:30h)(hour*milligram per deciliter (h*mg/dL))LixisenatideLiraglutideTotal
Mean169.41 ± 84.03183.86 ± 100.89176.28 ± 92.39
Postprandial Plasma Glucose (PPG) Excursion
Postprandial Plasma Glucose (PPG) Excursion(milligram per deciliter (mg/dL))LixisenatideLiraglutideTotal
Mean88.06 ± 29.3188.06 ± 35.8688.06 ± 32.47
Pro-insulin AUC(0:30-4:30h)
Pro-insulin AUC(0:30-4:30h)(hour*micro international unit/milliliter)LixisenatideLiraglutideTotal
Mean5.68 ± 6.256.54 ± 5.406.09 ± 5.86
Insulin AUC(0:30-4:30h)
Insulin AUC(0:30-4:30h)(hour*micro international unit/milliliter)LixisenatideLiraglutideTotal
Mean99.55 ± 43.6193.24 ± 57.3096.55 ± 50.50
C-Peptide AUC(0:30-4:30h)
C-Peptide AUC(0:30-4:30h)(hour*nanogram per milliliter (h*ng/mL))LixisenatideLiraglutideTotal
Mean10.61 ± 4.449.99 ± 4.8910.31 ± 4.65

4 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • Sanofi-Aventis Investigational Site Number 276006
    Berlin, 14050, Germany
  • Sanofi-Aventis Investigational Site Number 276004
    Kiel, 24105, Germany
  • Sanofi-Aventis Investigational Site Number 276002
    Mainz, 55116, Germany
  • Sanofi-Aventis Investigational Site Number 276003
    Mannheim, 68167, Germany
  • Sanofi-Aventis Investigational Site Number 276005
    Mönchengladbach, 41061, Germany
  • Sanofi-Aventis Investigational Site Number 276007
    München, 80636, Germany
  • Sanofi-Aventis Investigational Site Number 276001
    Neuss, 41460, Germany
09

References and documents

Publications

  • Kapitza C, Forst T, Coester HV, Poitiers F, Ruus P, Hincelin-Mery A. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Diabetes Obes Metab. 2013 Jul;15(7):642-9. doi: 10.1111/dom.12076. Epub 2013 Feb 25. PubMed 23368510 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01175473
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Aug 4, 2010
Start date
Aug 2010
Primary completion
Nov 2010
Completion
Nov 2010
Results posted
Oct 11, 2016
Last update
Nov 28, 2016

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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