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GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Sulfonylurea (GETGOAL-S)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713830
First Posted: July 14, 2008
Last Update Posted: December 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
Results First Submitted: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Sulfonylurea
Drug: Metformin

  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 136 centers in 16 countries between July 08, 2008 and January 14, 2011. The overall duration of treatment was at least 76 weeks (24 weeks main double-blind treatment; variable double-blind extension treatment).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1438 participants were screened of which 579 (40.3%) 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 859 participants were randomized.

Reporting Groups
  Description
Placebo 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 the end of treatment.
Lixisenatide 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 the end of treatment.

Participant Flow:   Overall Study
    Placebo   Lixisenatide
STARTED   286 [1]   573 
Modified Intent-to-Treat(mITT)Population   286 [2]   570 
Safety Population   285 [3]   574 [4] 
Subgroup for Standardized Meal Test   155 [5]   313 
COMPLETED   204   396 
NOT COMPLETED   82   177 
Adverse Event                23                71 
Lack of Efficacy                24                16 
Lost to Follow-up                2                9 
Withdrawal by Subject                13                23 
Poor Compliance to Protocol                7                14 
Familial and Personal Reasons                9                34 
Sponsor Decision                4                10 
[1] Randomized.
[2] All patients who received at least 1 dose;had baseline,at least 1 post-baseline efficacy assessment.
[3] All patients who were exposed to at least 1 dose, regardless of amount of treatment administered.
[4] 1 patient randomized to placebo received Lixisenatide (at least one dose)
[5] Patients at selected sites where standardized meal challenge 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.The one patient in the placebo group who received Lixisenatide was described in the Lixisenatide group.

Reporting Groups
  Description
Placebo 2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment.
Lixisenatide 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 the end of treatment.
Total Total of all reporting groups

Baseline Measures
   Placebo   Lixisenatide   Total 
Overall Participants Analyzed 
[Units: Participants]
 285   574   859 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.8  (10.1)   57.0  (9.8)   57.2  (9.9) 
Gender 
[Units: Participants]
     
Female   135   290   425 
Male   150   284   434 
Race/Ethnicity, Customized 
[Units: Participants]
     
Race: Caucasian/White   151   297   448 
Race: Black   9   17   26 
Race: Asian/Oriental   125   260   385 
Ethnicity: Hispanic   5   18   23 
Ethnicity: Non Hispanic   280   556   836 
Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 8.21  (0.84)   8.28  (0.86)   8.25  (0.85) 
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: Millimole per liter (mmol/L)]
Mean (Standard Deviation)
 16.44  (3.74)   16.69  (4.02)   16.60  (3.92) 
[1] The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 154 and 309 for Placebo and Lixisenatide treatment arms, respectively.
Fasting Plasma Glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation)
 9.29  (2.37)   9.67  (2.24)   9.55  (2.29) 
Body Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 84.42  (22.83)   82.30  (21.76)   83.00  (22.13) 
Homeostasis Model Assessment for Beta-cell Function (HOMA-beta) [1] 
[Units: Percentage of normal beta cells function]
Mean (Standard Deviation)
 36.43  (39.43)   34.28  (69.82)   34.99  (61.39) 
[1] Beta cell function was assessed by HOMA-beta. HOMA-beta (percentage [%] of normal beta cells function) = (20 multiplied by fasting plasma insulin [micro unit per milliliter]) divided by (FPG [mmol/L] minus 3.5). Number of patients analyzed = 152 and 306 for Placebo and Lixisenatide treatment arms, respectively.
Fasting glucagon [1] 
[Units: Nanogram per liter (ng/L)]
Mean (Standard Deviation)
 0.89  (0.55)   0.83  (0.43)   0.85  (0.47) 
[1] Number of patients analyzed = 152 and 309 for Placebo and Lixisenatide treatment arm, respectively.
2-hour postprandial glucagon [1] 
[Units: ng/L]
Mean (Standard Deviation)
 102.27  (39.37)   97.83  (31.94)   99.31  (34.60) 
[1] Number of patients analyzed = 149 and 300 for Placebo and Lixisenatide treatment arm, respectively.
Fasting plasma insulin (FPI) [1] 
[Units: Picomole per liter (pmol/L)]
Mean (Standard Deviation)
 66.89  (63.92)   61.34  (52.63)   63.18  (56.61) 
[1] Number of patients analyzed = 152 and 306 for Placebo and Lixisenatide treatment arm, respectively.
2-hour postprandial plasma insulin [1] 
[Units: pmol/L]
Mean (Standard Deviation)
 281.26  (243.56)   259.44  (182.64)   266.76  (205.09) 
[1] Number of patients analyzed = 154 and 305 for Placebo and Lixisenatide treatment arm, respectively.
Fasting proinsulin [1] 
[Units: pmol/L]
Mean (Standard Deviation)
 34.39  (32.61)   33.35  (27.43)   33.69  (29.17) 
[1] Number of patients analyzed = 138 and 290 for Placebo and Lixisenatide treatment arm, respectively.
2-hour postprandial proinsulin [1] 
[Units: pmol/L]
Mean (Standard Deviation)
 61.73  (46.48)   62.12  (44.80)   61.99  (45.31) 
[1] Number of patients analyzed = 130 and 257 for Placebo and Lixisenatide treatment arm, respectively.
Fasting C-peptide [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 0.89  (0.55)   0.83  (0.43)   0.85  (0.47) 
[1] Number of patients analyzed = 152 and 309 for Placebo and Lixisenatide treatment arm, respectively.
2-hour postprandial C-peptide [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 2.12  (1.05)   1.99  (0.90)   2.03  (0.95) 
[1] Number of patients analyzed = 152 and 308 for Placebo and Lixisenatide treatment arm, respectively.
Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 6.84  (3.78)   6.99  (3.71)   6.94  (3.73) 
[1] Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients analyzed = 154 and 309 for Placebo and Lixisenatide treatment arms, respectively.
Fasting proinsulin-to-insulin ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 0.62  (0.36)   0.70  (0.57)   0.67  (0.51) 
[1] Number of patients analyzed = 137 and 285 for Placebo and Lixisenatide treatment arm, respectively.
2-hour postprandial proinsulin-to-insulin ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 0.30  (0.22)   0.32  (0.24)   0.31  (0.23) 
[1] Number of patients analyzed = 130 and 253 for Placebo and Lixisenatide treatment arm, respectively.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:   Change From Baseline in Body Weight at Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:   Change From Baseline in Beta-cell Function Assessed by HOMA-beta at Week 24   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Change From Baseline in Fasting Glucagon and 2-hour Postprandial Glucagon at Week 24   [ Time Frame: Baseline, Week 24 ]

7.  Secondary:   Change From Baseline in Fasting Plasma Insulin (FPI) and 2-hour Postprandial Plasma Insulin at Week 24   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:   Change From Baseline in Fasting Proinsulin and 2-hour Postprandial Proinsulin at Week 24   [ Time Frame: Baseline, Week 24 ]

9.  Secondary:   Change From Baseline in Fasting C-peptide and 2-hour Postprandial C-peptide at Week 24   [ Time Frame: Baseline, Week 24 ]

10.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24   [ Time Frame: Week 24 ]

11.  Secondary:   Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24   [ Time Frame: Week 24 ]

12.  Secondary:   Percentage of Patients Requiring Rescue Therapy During Main 24-Week Period   [ Time Frame: Baseline up to Week 24 ]

13.  Other Pre-specified:   Change From Baseline in Glucose Excursion at Week 24   [ Time Frame: Baseline, Week 24 ]

14.  Other Pre-specified:   Change From Baseline in Fasting Proinsulin-to-insulin Ratio and 2-hour Postprandial Proinsulin-to-insulin Ratio at Week 24   [ Time Frame: Baseline, Week 24 ]

15.  Other Pre-specified:   Percentage of Patients With at Least 5% Weight Loss From Baseline at Week 24   [ Time Frame: Baseline, Week 24 ]

16.  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, for up to 120 weeks ]


  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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00713830     History of Changes
Other Study ID Numbers: EFC6015
EudraCT 2007-005881-11
First Submitted: July 10, 2008
First Posted: July 14, 2008
Results First Submitted: August 18, 2016
Results First Posted: December 14, 2016
Last Update Posted: December 14, 2016



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