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Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients (GetGoal-Duo-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768559
First Posted: January 15, 2013
Last Update Posted: January 4, 2017
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 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Lixisenatide (AVE0010)
Drug: Insulin glulisine QD
Drug: Insulin glulisine TID
Drug: Insulin Glargine (Mandatory background drug)
Drug: Metformin (Background drug)

  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 199 centers in 18 countries. A total of 2159 participants were screened between January 08, 2013 and April 10, 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants underwent a 12-week run–in period with switch from other basal insulins to insulin glargine. A total of 1265 participants were screen failures/run-in failures; the most frequent reason for run-in failure was that glycosylated hemoglobin (HbA1c) criteria were not met at the end of run-in phase. 894 participants were randomized.

Reporting Groups
  Description
Lixisenatide Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Insulin Glulisine QD Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
Insulin Glulisine TID Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.

Participant Flow:   Overall Study
    Lixisenatide   Insulin Glulisine QD   Insulin Glulisine TID
STARTED   298   298   298 
Treated   298   298 [1]   297 [2] 
COMPLETED   268   281   285 
NOT COMPLETED   30   17   13 
Randomized but not treated                0                0                1 
Adverse Event                15                2                5 
Lack of Efficacy                6                4                0 
Poor compliance to protocol                0                3                2 
Other than specified                9                8                5 
[1] 1 participant received Insulin Glulisine TID (for more than 50%)
[2] 4 participants received Insulin Glulisine QD (for more than 50%)



  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 QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
Insulin Glulisine QD Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
Insulin Glulisine TID Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
Total Total of all reporting groups

Baseline Measures
   Lixisenatide   Insulin Glulisine QD   Insulin Glulisine TID   Total 
Overall Participants Analyzed 
[Units: Participants]
 298   298   298   894 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (8.6)   60.2  (8.6)   59.4  (9.5)   59.8  (8.9) 
Gender 
[Units: Participants]
Count of Participants
       
Female      160  53.7%      163  54.7%      166  55.7%      489  54.7% 
Male      138  46.3%      135  45.3%      132  44.3%      405  45.3% 
Race 
[Units: Participants]
       
Caucasian/White   276   280   272   828 
Black   13   11   12   36 
Asian/Oriental   9   7   13   29 
Other   0   0   1   1 
Ethnicity 
[Units: Participants]
       
Hispanic   63   58   68   189 
Non-Hispanic   235   240   230   705 
Metformin Use at Screening 
[Units: Participants]
       
Yes   262   260   259   781 
No   36   38   39   113 
Number of Participants with Categorical Body Mass Index (BMI) 
[Units: Participants]
       
<30 kg/m^2   97   118   97   312 
≥30 kg/m^2   201   180   200   581 
Participants not analyzed for BMI   0   0   1   1 
BMI [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
 32.27  (4.57)   31.86  (4.39)   32.50  (4.60)   32.21  (4.52) 
[1] 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline BMI analysis.
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 90.06  (17.31)   88.45  (15.84)   90.08  (17.18)   89.53  (16.79) 
[1] 893 participants (298 in Lixisenatide arm, 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for baseline weight analysis.
HbA1c [1] 
[Units: Percentage of hemoglobin]
Mean (Standard Deviation)
 7.77  (0.55)   7.73  (0.59)   7.79  (0.60)   7.76  (0.58) 
[1] 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for HbA1c analysis.
Fasting Plasma Glucose (FPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 6.58  (1.82)   6.84  (1.98)   6.65  (1.89)   6.69  (1.90) 
[1] 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for FPG analysis.
2-Hour Postprandial Plasma Glucose (PPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 14.26  (3.55)   14.02  (3.59)   14.25  (3.35)   14.18  (3.47) 
[1] 258 participants (79 in Lixisenatide arm; 77 in Insulin glulisine QD and 102 in Insulin glulisine TID) were included for PPG analysis.
2-Hour Glucose Excursion [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 7.31  (3.19)   7.31  (3.63)   7.35  (3.34)   7.33  (3.37) 
[1] 243 participants (73 in Lixisenatide arm, 74 in Insulin glulisine QD and 96 in Insulin glulisine TID) were included for 2-hour glucose excursion analysis.
Average 7-Point Self-monitored Plasma Glucose (SMPG) [1] 
[Units: mmol/L]
Mean (Standard Deviation)
 9.02  (1.75)   9.07  (1.74)   8.99  (1.57)   9.02  (1.68) 
[1] 877 participants (292 in Lixisenatide arm; 291 in Insulin glulisine QD and 294 in Insulin glulisine TID) were included for average 7-point SMPG analysis.
Insulin Glargine Dose [1] 
[Units: Units (U)]
Mean (Standard Deviation)
 67.25  (31.95)   64.72  (32.07)   64.97  (26.90)   65.65  (30.39) 
[1] 893 participants (298 in Lixisenatide arm; 298 in Insulin glulisine QD and 297 in Insulin glulisine TID) were included for Insulin glargine dose analysis.
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 11.89  (6.43)   12.33  (6.75)   12.41  (6.80)   12.21  (6.66) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

2.  Primary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Percentage of Participants With HbA1c Level <7% and ≤6.5% at Week 26   [ Time Frame: Week 26 ]

4.  Secondary:   Percentage of Participants With no Weight Gain at Week 26   [ Time Frame: Week 26 ]

5.  Secondary:   Change in Average 7-point SMPG Profiles From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

6.  Secondary:   Change in FPG From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

7.  Secondary:   Change in PPG From Baseline to Week 26 (in Participants Who Had an Injection of Investigational Medicinal Product [IMP] Before Breakfast)   [ Time Frame: Baseline, Week 26 ]

8.  Secondary:   Change in Glucose Excursions From Baseline to Week 26 (in Participants Who Had an Injection of IMP Before Breakfast)   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Change in Insulin Glargine Dose From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

10.  Secondary:   Insulin Glulisine Dose at Week 26   [ Time Frame: Week 26 ]

11.  Secondary:   Total Insulin Dose at Week 26   [ Time Frame: Week 26 ]

12.  Secondary:   Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration (maximum of 185 days) ]

13.  Secondary:   Percentage of Participants Who Reached the Target of HbA1c <7% at Week 26 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26 Week Treatment Period   [ Time Frame: Week 26 ]

14.  Secondary:   Percentage of Participants Who Reached the Target of HbA1c <7% and Had no Weight Gain at Week 26   [ Time Frame: Week 26 ]

15.  Secondary:   Percentage of Participants Who Reached the Target of HbA1c <7%, Had no Weight Gain at Week 26, and Did Not Experience Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia During 26-Week Treatment Period   [ Time Frame: Week 26 ]


  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: NCT01768559     History of Changes
Other Study ID Numbers: EFC12626
2012-004096-38 ( EudraCT Number )
U1111-1131-4936 ( Other Identifier: UTN )
First Submitted: January 11, 2013
First Posted: January 15, 2013
Results First Submitted: August 22, 2016
Results First Posted: January 4, 2017
Last Update Posted: January 4, 2017