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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO)

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ClinicalTrials.gov Identifier: NCT00688701
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Enrollment 361
Recruitment Details The study was conducted at 61 centers (68 were initiated) in 12 countries between May 14, 2008 and December 14, 2009.
Pre-assignment Details A total of 795 patients were screened of which 434 (54.6%) were screen failures; main reason for screen failure was glycosylated hemoglobin (HbA1c) values being out of the defined protocol range (greater than or equal to 7% and less than or equal to 10%). A total of 361 patients were randomized.
Arm/Group Title Placebo (Two-Step Titration) Placebo (One-Step Titration) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description 2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. 1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12. 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
Period Title: Overall Study
Started 61 [1] 61 120 119
Treated/Safety Population 61 [2] 61 120 119
Modified Intent-to-Treat(mITT)Population 61 [3] 60 120 118
Subgroup for Standardized Meal Test 27 [4] 35 60 65
Completed 57 56 110 108
Not Completed 4 5 10 11
Reason Not Completed
Adverse Event             1             0             5             3
Lack of Efficacy             0             1             0             0
Withdrawal by Subject             3             3             4             8
Poor compliance to protocol             0             1             1             0
[1]
Randomized
[2]
All patients who received at least 1 dose, regardless of amount of treatment administered.
[3]
All patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment.
[4]
Patients at selected sites where standardized meal test was performed.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration) Total
Hide Arm/Group Description Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. 2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 12. 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12. Total of all reporting groups
Overall Number of Baseline Participants 122 120 119 361
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 122 participants 120 participants 119 participants 361 participants
54.1  (11.0) 53.3  (9.7) 53.8  (10.9) 53.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 120 participants 119 participants 361 participants
Female
62
  50.8%
57
  47.5%
56
  47.1%
175
  48.5%
Male
60
  49.2%
63
  52.5%
63
  52.9%
186
  51.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 122 participants 120 participants 119 participants 361 participants
Race: Caucasian/White 90 88 85 263
Race: Black 3 0 3 6
Race: Asian/Oriental 24 27 29 80
Race: Other 5 5 2 12
Ethnicity: Hispanic 31 25 22 78
Ethnicity: Non Hispanic 91 95 97 283
Glycosylated Hemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 122 participants 120 participants 119 participants 361 participants
8.07  (0.91) 7.98  (0.92) 8.07  (0.87) 8.04  (0.90)
2-Hour Postprandial Plasma Glucose (PPG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 122 participants 120 participants 119 participants 361 participants
14.27  (4.84) 14.81  (3.87) 14.62  (3.41) 14.57  (4.05)
[1]
Measure Description: The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 60, 59 and 65 for Placebo (Combined), Lixisenatide (Two-Step Titration) and Lixisenatide (One-Step Titration) treatment arms, respectively, as meal challenge test was performed at selected sites only.
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 122 participants 120 participants 119 participants 361 participants
86.08  (22.21) 89.04  (22.16) 86.50  (21.00) 87.20  (21.78)
Fasting Plasma Glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  Millimole per liter (mmol/L)
Number Analyzed 122 participants 120 participants 119 participants 361 participants
8.90  (2.16) 9.15  (1.99) 9.04  (1.97) 9.03  (2.04)
Glucose Excursion   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 122 participants 120 participants 119 participants 361 participants
4.82  (3.69) 5.67  (3.05) 5.34  (2.96) 5.27  (3.25)
[1]
Measure Description: Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients analyzed = 60, 59 and 65 for Placebo (Combined), Lixisenatide (Two-Step Titration) and Lixisenatide (One-Step Titration) treatment arms, respectively, as meal challenge test was performed at selected sites only.
Duration of Diabetes  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 122 participants 120 participants 119 participants 361 participants
1.37
(0.2 to 12.5)
1.42
(0.2 to 21.5)
1.11
(0.2 to 23.9)
1.33
(0.2 to 23.9)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 122 participants 120 participants 119 participants 361 participants
31.76  (6.69) 32.34  (6.72) 31.65  (6.62) 31.91  (6.66)
[1]
Measure Description: BMI was calculated by dividing body weight by the height squared.
1.Primary Outcome
Title Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Hide Description Absolute change = HbA1c value at Week 12 minus HbA1c value at baseline. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population:all randomized patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment, irrespective of compliance with study protocol/procedures. Last observation carried forward used. Number of patients analyzed=patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 112 113 114
Least Squares Mean (Standard Error)
Unit of Measure: percentage of hemoglobin
-0.19  (0.121) -0.73  (0.116) -0.85  (0.119)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Combined), Lixisenatide (Two-Step Titration)
Comments

To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.

Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value -0.54
Confidence Interval (2-Sided) 95%
-0.785 to -0.300
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.123
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Combined), Lixisenatide (One-Step Titration)
Comments

To detect a difference of 0.5% in change in HbA1c at Week 12 between 1 lixisenatide arm and placebo (combined), 120 patients per group would provide a power of 90% assuming common standard deviation of 1.2% with 2-sided test at 5% significance level.

Statistical testing: 2-sided at significance level=0.05. Analysis of co-variance (ANCOVA) included treatment arms, randomization strata of screening HbA1c (<8.0,>=8.0%), BMI (<30,>=30 kg/m^2), country as fixed effects, baseline HbA1c as covariate.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Stepwise testing procedure applied to control type 1 error: Lixisenatide (2-step titration) was compared with Placebo (combined), if found statistically significant, then Lixisenatide (1-step titration) arm compared with Placebo (combined).
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-0.903 to -0.423
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.122
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12
Hide Description The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal (performed in selected sites). Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup for standardized meal test. Missing data was imputed using last observation carried forward (LOCF). Here, number of patients analyzed = patients with baseline and at least 1 post-baseline 2-hour PPG assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 54 53 62
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.65  (0.563) -4.51  (0.572) -5.47  (0.549)
3.Secondary Outcome
Title Change From Baseline in Body Weight at Week 12
Hide Description Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 116 117 115
Least Squares Mean (Standard Error)
Unit of Measure: kilogram
-1.98  (0.341) -1.96  (0.326) -1.92  (0.338)
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Hide Description Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 1 day after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline FPG assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 121 119 118
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.19  (0.255) -0.68  (0.247) -0.89  (0.254)
5.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12
Hide Description The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 112 113 114
Measure Type: Number
Unit of Measure: percentage of participants
26.8 52.2 46.5
6.Secondary Outcome
Title Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12
Hide Description The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline HbA1c assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 112 113 114
Measure Type: Number
Unit of Measure: percentage of participants
12.5 31.9 25.4
7.Secondary Outcome
Title Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period
Hide Description Routine fasting self monitored plasma glucose (SMPG) and central laboratory FPG values were used to determine the requirement of rescue medication. If fasting SMPG value exceeded the specified limit for 3 consecutive days, the central laboratory FPG was performed. Threshold values for fasting SMPG/FPG: from baseline to Week 8: >270 milligram/deciliter (mg/dL) (15 mmol/L) and from Week 8 to Week 12: >240 mg/dL (13.3 mmol/L). For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 121 120 118
Measure Type: Number
Unit of Measure: percentage of participants
2.5 1.7 0.8
8.Other Pre-specified Outcome
Title Change From Baseline in Glucose Excursion at Week 12
Hide Description Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the standardized meal test (performed in selected sites), before study drug administration. Change was calculated by subtracting baseline value from Week 12 value. The on-treatment period for this efficacy variable is the time from the first dose of study drug up to the last dosing day of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup for standardized meal test. Missing data was imputed using LOCF. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline glucose excursion assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 54 53 62
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.67  (0.447) -3.77  (0.454) -4.36  (0.436)
9.Other Pre-specified Outcome
Title Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12
Hide Description The on-treatment period for this efficacy variable is the time from the first dose of study drug up to 3 days after the last dose of study drug or up to the introduction of rescue therapy, whichever is the earliest. For a patient to be included in mITT population, both baseline and at least 1 post baseline assessment for at least 1 efficacy variable, were required.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population. Here, number of patients analyzed = patients with baseline and at least 1 post-baseline body weight assessment during on-treatment period.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 116 117 115
Measure Type: Number
Unit of Measure: percentage of participants
17.2 16.2 18.3
10.Other Pre-specified Outcome
Title Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia
Hide Description Symptomatic hypoglycemia was an event with clinical symptoms that were considered to result from a hypoglycemic episode with an accompanying plasma glucose less than 60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration if no plasma glucose measurement was available. Severe symptomatic hypoglycemia was symptomatic hypoglycemia event in which the patient required the assistance of another person and was associated with either a plasma glucose level below 36 mg/dL (2.0 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration, if no plasma glucose measurement was available.
Time Frame First dose of study drug up to 3 days after the last dose administration
Hide Outcome Measure Data
Hide 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.
Arm/Group Title Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration)
Hide Arm/Group Description:
Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
2-step initiation regimen of lixisenatide.
1-step initiation regimen of lixisenatide.
Overall Number of Participants Analyzed 122 120 119
Measure Type: Number
Unit of Measure: participants
Symptomatic hypoglycemia 2 3 1
Severe symptomatic hypoglycemia 0 0 0
Time Frame First dose of study drug up to 3 days after the last dose administration
Adverse Event Reporting Description Median exposure to study treatment was 85 days for all 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 Placebo (Two-Step Titration) Placebo (One-Step Titration) Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration) Lixisenatide (Combined)
Hide Arm/Group Description 2-step initiation regimen of volume matching placebo. 1-step initiation regimen of volume matching placebo. Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo. 2-step initiation regimen of lixisenatide. 1-step initiation regimen of lixisenatide. Included all patients who received 2-step initiation regimen of lixisenatide and 1-step initiation regimen of lixisenatide.
All-Cause Mortality
Placebo (Two-Step Titration) Placebo (One-Step Titration) Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration) Lixisenatide (Combined)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Two-Step Titration) Placebo (One-Step Titration) Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration) Lixisenatide (Combined)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/61 (4.92%)   2/61 (3.28%)   5/122 (4.10%)   1/120 (0.83%)   0/119 (0.00%)   1/239 (0.42%) 
Cardiac disorders             
Acute myocardial infarction * 1  1/61 (1.64%)  0/61 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/119 (0.00%)  0/239 (0.00%) 
Endocrine disorders             
Goitre * 1  0/61 (0.00%)  0/61 (0.00%)  0/122 (0.00%)  1/120 (0.83%)  0/119 (0.00%)  1/239 (0.42%) 
Gastrointestinal disorders             
Ileus * 1  1/61 (1.64%)  0/61 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/119 (0.00%)  0/239 (0.00%) 
Injury, poisoning and procedural complications             
Ulna fracture * 1  0/61 (0.00%)  1/61 (1.64%)  1/122 (0.82%)  0/120 (0.00%)  0/119 (0.00%)  0/239 (0.00%) 
Investigations             
Blood glucose increased * 1  0/61 (0.00%)  1/61 (1.64%)  1/122 (0.82%)  0/120 (0.00%)  0/119 (0.00%)  0/239 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Colon cancer stage III * 1  1/61 (1.64%)  0/61 (0.00%)  1/122 (0.82%)  0/120 (0.00%)  0/119 (0.00%)  0/239 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo (Two-Step Titration) Placebo (One-Step Titration) Placebo (Combined) Lixisenatide (Two-Step Titration) Lixisenatide (One-Step Titration) Lixisenatide (Combined)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/61 (18.03%)   8/61 (13.11%)   19/122 (15.57%)   35/120 (29.17%)   31/119 (26.05%)   66/239 (27.62%) 
Gastrointestinal disorders             
Nausea * 1  3/61 (4.92%)  2/61 (3.28%)  5/122 (4.10%)  29/120 (24.17%)  24/119 (20.17%)  53/239 (22.18%) 
Vomiting * 1  0/61 (0.00%)  0/61 (0.00%)  0/122 (0.00%)  9/120 (7.50%)  8/119 (6.72%)  17/239 (7.11%) 
Nervous system disorders             
Dizziness * 1  1/61 (1.64%)  2/61 (3.28%)  3/122 (2.46%)  9/120 (7.50%)  4/119 (3.36%)  13/239 (5.44%) 
Headache * 1  9/61 (14.75%)  5/61 (8.20%)  14/122 (11.48%)  10/120 (8.33%)  9/119 (7.56%)  19/239 (7.95%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
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
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Name/Title: Trial Transparency Team
Organization: Sanofi
EMail: Contact-us@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00688701     History of Changes
Other Study ID Numbers: EFC6018
EudraCT 2007-005887-29
First Submitted: May 7, 2008
First Posted: June 3, 2008
Results First Submitted: August 16, 2016
Results First Posted: December 12, 2016
Last Update Posted: December 12, 2016