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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00715624
First received: July 11, 2008
Last updated: October 14, 2016
Last verified: October 2016
Results First Received: August 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Basal Insulin
Drug: Metformin
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 111 centers in 15 countries between July 29, 2008 and February 8, 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 879 patients were screened of which 383 (43.6%) 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 496 patients 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   167 [1]   329 
Treated/Safety Population   167 [2]   328 
Modified Intent-to-Treat(mITT)Population   166 [3]   327 
COMPLETED   115   213 
NOT COMPLETED   52   116 
Adverse Event                12                37 
Lack of Efficacy                11                11 
Lost to Follow-up                1                2 
Protocol Violation                1                0 
Withdrawal by Subject                11                25 
Familial and personal reasons                10                22 
Poor compliance                6                13 
Sponsor decision                0                4 
Incorrect randomization (not treated)                0                1 
Other                0                1 
[1] Randomized
[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,at least 1 post-baseline efficacy assessment.



  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 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]
 167   328   495 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.9  (9.8)   57.4  (9.5)   57.2  (9.6) 
Gender 
[Units: Participants]
     
Female   85   182   267 
Male   82   146   228 
Race/Ethnicity, Customized 
[Units: Participants]
     
Race: Caucasian/White   130   254   384 
Race: Black   6   14   20 
Race: Asian/Oriental   30   53   83 
Race: Other   1   7   8 
Ethnicity: Hispanic   40   94   134 
Ethnicity: Non Hispanic   127   234   361 
Glycosylated Hemoglobin (HbA1c) 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 8.37  (0.84)   8.42  (0.88)   8.40  (0.87) 
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 16.11  (3.86)   16.47  (4.30)   16.35  (4.15) 
[1] The 2-hour PPG test measured blood glucose 2 hours after eating a standardized meal. Number of patients analyzed = 153 and 302 for Placebo and Lixisenatide treatment arms, respectively.
Average 7-Point Self Monitored Plasma Glucose (SMPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 10.58  (2.69)   10.76  (2.61)   10.70  (2.64) 
[1] Patients recorded a 7-point plasma glucose profile before and 2 hours after each meal and at bedtime once in a week and the average value for the 7-time points was calculated. Number of patients analyzed = 155 and 301 for Placebo and Lixisenatide treatment arms, respectively.
Fasting Plasma Glucose (FPG) 
[Units: Millimole per liter (mmol/L)]
Mean (Standard Deviation)
 8.05  (2.65)   8.13  (2.83)   8.10  (2.76) 
Body Weight 
[Units: Kilogram (kg)]
Mean (Standard Deviation)
 88.94  (20.84)   87.10  (20.01)   87.72  (20.29) 
Total Insulin Dose 
[Units: Units per day]
Mean (Standard Deviation)
 57.73  (34.54)   53.43  (33.89)   54.88  (34.14) 
Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 7.32  (3.43)   7.59  (3.60)   7.50  (3.54) 
[1] Glucose excursion = 2-hour PPG minus plasma glucose 30 minutes prior to the meal test, before study drug administration. Number of patients analyzed = 153 and 301 for Placebo and Lixisenatide treatment arms, respectively.
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 12.43  (6.33)   12.48  (7.04)   12.46  (6.80) 
Body Mass Index (BMI) [1] 
[Units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
 32.56  (6.32)   31.91  (6.17)   32.13  (6.22) 
[1] BMI was calculated by dividing body weight by the height squared.
Basal Insulin Treatment Duration 
[Units: Years]
Mean (Standard Deviation)
 3.20  (3.96)   3.06  (3.37)   3.11  (3.57) 
Number of Patients With Insulin Therapy at Baseline [1] 
[Units: Participants]
     
Glargine   83   165   248 
Detemir   19   24   43 
Neutral protamine hagedorn (NPH)   64   134   198 
Premix (Mixed Insulin)   3   5   8 
[1] NPH included isophane insulin and insulin human injection, isophane. Premix insulin included Novolin 70/30 mix and Humalog 75/25 mix.
Number of Patients With Metformin use at Baseline 
[Units: Participants]
     
Yes   131   261   392 
No   36   67   103 
Metformin Daily Dose [1] 
[Units: Milligram (mg) per day]
Mean (Standard Deviation)
 2008.02  (441.88)   1961.02  (459.07)   1976.72  (453.38) 
[1] Here, number of patients analyzed = 131 and 261 for Placebo and Lixisenatide treatment arm, respectively as only these participants received metformin.


  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 Average 7-Point Self Monitored Plasma Glucose (SMPG) Profiles at Week 24   [ Time Frame: Baseline, Week 24 ]

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

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

6.  Secondary:   Change From Baseline in Total Insulin Dose at Week 24   [ Time Frame: Baseline, Week 24 ]

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

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

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

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

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

12.  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 125 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: NCT00715624     History of Changes
Other Study ID Numbers: EFC6016
2007-005886-36 ( EudraCT Number )
Study First Received: July 11, 2008
Results First Received: August 18, 2016
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration