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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00688701
First received: May 7, 2008
Last updated: October 18, 2016
Last verified: October 2016
Results First Received: August 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 61 centers (68 were initiated) in 12 countries between May 14, 2008 and December 14, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo (Two-Step Titration) 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.
Placebo (One-Step Titration) 1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
Lixisenatide (Two-Step Titration) 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.
Lixisenatide (One-Step Titration) 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.

Participant Flow:   Overall Study
    Placebo (Two-Step Titration)   Placebo (One-Step Titration)   Lixisenatide (Two-Step Titration)   Lixisenatide (One-Step Titration)
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 
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population included all randomized patients who were exposed to at least 1 dose of study drug, regardless of the amount of treatment administered.

Reporting Groups
  Description
Placebo (Combined) Included all patients who received 2-step initiation regimen of volume matching placebo and 1-step initiation regimen of volume matching placebo.
Lixisenatide (Two-Step Titration) 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.
Lixisenatide (One-Step Titration) 1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to Week 12.
Total Total of all reporting groups

Baseline Measures
   Placebo (Combined)   Lixisenatide (Two-Step Titration)   Lixisenatide (One-Step Titration)   Total 
Overall Participants Analyzed 
[Units: Participants]
 122   120   119   361 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.1  (11.0)   53.3  (9.7)   53.8  (10.9)   53.7  (10.5) 
Gender 
[Units: Participants]
       
Female   62   57   56   175 
Male   60   63   63   186 
Race/Ethnicity, Customized 
[Units: 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) 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 8.07  (0.91)   7.98  (0.92)   8.07  (0.87)   8.04  (0.90) 
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 14.27  (4.84)   14.81  (3.87)   14.62  (3.41)   14.57  (4.05) 
[1] 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 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 86.08  (22.21)   89.04  (22.16)   86.50  (21.00)   87.20  (21.78) 
Fasting Plasma Glucose (FPG) 
[Units: Millimole per liter (mmol/L)]
Mean (Standard Deviation)
 8.90  (2.16)   9.15  (1.99)   9.04  (1.97)   9.03  (2.04) 
Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 4.82  (3.69)   5.67  (3.05)   5.34  (2.96)   5.27  (3.25) 
[1] 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 
[Units: Years]
Median (Full Range)
 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] 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 31.76  (6.69)   32.34  (6.72)   31.65  (6.62)   31.91  (6.66) 
[1] BMI was calculated by dividing body weight by the height squared.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Change From Baseline in Body Weight at Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   Percentage of Patients Requiring Rescue Therapy During the Double-Blind Treatment Period   [ Time Frame: Baseline up to Week 12 ]

8.  Other Pre-specified:   Change From Baseline in Glucose Excursion at Week 12   [ Time Frame: Baseline, Week 12 ]

9.  Other Pre-specified:   Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 12   [ Time Frame: Baseline, Week 12 ]

10.  Other Pre-specified:   Number of Patients With Symptomatic Hypoglycemia and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-us@sanofi.com


Publications of Results:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00688701     History of Changes
Other Study ID Numbers: EFC6018
EudraCT 2007-005887-29
Study First Received: May 7, 2008
Results First Received: August 16, 2016
Last Updated: October 18, 2016