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Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients (GetGoal-O)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01798706
First received: February 22, 2013
Last updated: October 14, 2016
Last verified: October 2016
Results First Received: August 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Placebo
Drug: Antidiabetic background therapy

  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 83 centers in 13 countries. A total of 786 participants were screened between June 10, 2013 and July 09, 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 426 participants underwent 4 week placebo run–in period. 436 participants were screen failures and 76 were run-in failures; the most frequent reason for screen and run-in failure was glycosylated hemoglobin (HbA1c) criteria not met at end of the run-in phase. A total of 350 participants were randomized.

Reporting Groups
  Description
Lixisenatide Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.

Participant Flow:   Overall Study
    Lixisenatide   Placebo
STARTED   176   174 
COMPLETED   155   153 
NOT COMPLETED   21   21 
Adverse Event                15                10 
Lack of Efficacy                0                2 
Poor compliance to protocol                1                0 
Other than specified above                5                9 



  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.
No text entered.

Reporting Groups
  Description
Lixisenatide Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
Placebo Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
Total Total of all reporting groups

Baseline Measures
   Lixisenatide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   174   350 
Age 
[Units: Years]
Mean (Standard Deviation)
 74  (4)   74.4  (3.8)   74.2  (3.9) 
Gender 
[Units: Participants]
     
Female   84   84   168 
Male   92   90   182 
Race 
[Units: Participants]
     
Caucasian/white   128   122   250 
Black   3   0   3 
Asian/Oriental   5   11   16 
Other   40   41   81 
Ethnicity 
[Units: Participants]
     
Hispanic   51   48   99 
Not Hispanic   125   126   251 
Number of Participants with Categorical BMI 
[Units: Participants]
     
<30 kg/m^2   102   96   198 
≥30 kg/m^2   74   78   152 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.91  (3.7)   30.09  (4.53)   30.00  (4.13) 
Body Weight 
[Units: Kg]
Mean (Standard Deviation)
 80.81  (14.54)   80.08  (16.76)   80.45  (15.66) 
HbA1c 
[Units: Percentage of HbA1c]
Mean (Standard Deviation)
 8.04  (0.72)   8.05  (0.69)   8.04  (0.71) 
Fasting Plasma Glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation)
 8.83  (2.38)   8.89  (2.26)   8.86  (2.32) 
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 15.18  (3.78)   14.87  (3.69)   15.03  (3.74) 
[1] 347 participants (174 in lixisenatide arm and 173 in placebo arm) were included for PPG analysis.
Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 6.51  (3.15)   6.02  (3.17)   6.26  (3.16) 
[1] 345 participants (173 in lixisenatide arm and 172 in placebo arm) were included for glucose excursion analysis.
7-Point Self-monitored Plasma Glucose (SMPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 9.79  (2.02)   9.97  (1.98)   9.87  (2.00) 
[1] 333 participants (171 in lixisenatide arm and 162 in placebo arm) were included for 7 point SMPG analysis.
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 13.63  (7.34)   14.63  (7.87)   14.13  (7.62) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change in HbA1c From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change in 2-Hour PPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:   Change in Average 7-point SMPG Profiles From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

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

5.  Secondary:   Change in FPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:   Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period   [ Time Frame: Baseline up to Week 24 ]

7.  Secondary:   Change in Plasma Glucose Excursions From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:   Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy)   [ Time Frame: Baseline, Week 24 ]

9.  Secondary:   Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration (maximum of 171 days) ]

10.  Secondary:   Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia   [ Time Frame: Week 24 ]

11.  Secondary:   Percentage of Participants With Gastrointestinal Disorders   [ Time Frame: Up to Day 171 ]


  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



Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01798706     History of Changes
Other Study ID Numbers: EFC12703
2012-003292-19 ( EudraCT Number )
U1111-1132-9156 ( Other Identifier: UTN )
Study First Received: February 22, 2013
Results First Received: August 22, 2016
Last Updated: October 14, 2016
Health Authority: United States: Food and Drug Administration