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Trial record 7 of 8 for:    LixiLan

Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM (LixiLan-O)

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ClinicalTrials.gov Identifier: NCT02058147
Recruitment Status : Completed
First Posted : February 7, 2014
Results First Posted : February 10, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Insulin glargine/lixisenatide Fixed Ratio Combination
Drug: Insulin glargine (HOE901)
Drug: Lixisenatide (AVE0010)
Drug: Metformin

  Participant Flow

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 240 centers in 23 countries. A total of 2457 participants were screened between February 12, 2014 and September 16, 2014. 978 participants were not eligible for run-in mainly due to glycosylated hemoglobin (HbA1c) value at screening visit being out of the protocol defined range.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After 2 weeks screening period, 1479 participants underwent 4-week run-in period. 309 participants were run-in failures. A total of 1170 participants were randomized in 2:2:1 to insulin glargine/lixisenatide, insulin glargine and lixisenatide arms respectively in open-label treatment period.

Reporting Groups
  Description
Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
Insulin Glargine Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
Lixisenatide Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).

Participant Flow:   Overall Study
    Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)   Insulin Glargine   Lixisenatide
STARTED   469   467   234 
Treated   469   467   233 
COMPLETED   440   440   205 
NOT COMPLETED   29   27   29 
Randomized but not treated                0                0                1 
Adverse Event                12                9                21 
Lack of Efficacy                1                0                3 
Poor compliance to protocol                8                9                4 
Other than specified                8                9                0 



  Baseline Characteristics

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
Insulin Glargine/Lixisenatide Fixed Ratio Combination FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
Insulin Glargine Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
Lixisenatide Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
Total Total of all reporting groups

Baseline Measures
   Insulin Glargine/Lixisenatide Fixed Ratio Combination   Insulin Glargine   Lixisenatide   Total 
Overall Participants Analyzed 
[Units: Participants]
 469   467   234   1170 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.2  (9.5)   58.3  (9.4)   58.7  (8.7)   58.4  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      247  52.7%      230  49.3%      101  43.2%      578  49.4% 
Male      222  47.3%      237  50.7%      133  56.8%      592  50.6% 
Race 
[Units: Participants]
Count of Participants
       
Caucasian   417   421   216   1054 
Black   33   33   12   78 
Asian/Oriental   8   7   3   18 
Other   11   6   3   20 
Ethnicity 
[Units: Participants]
Count of Participants
       
Hispanic   85   87   51   223 
Not Hispanic   384   380   183   947 
Second Oral Anti-diabetic Drug (OAD) Use 
[Units: Participants]
Count of Participants
       
Yes   274   270   133   677 
No   195   197   101   493 
Second OAD Use at Screening by Class 
[Units: Participants]
Count of Participants
       
Sulfonylurea   259   249   123   631 
Glinide   3   10   5   18 
Sodium-glucose co-transporter-2 inhibitor   2   2   0   4 
Dipeptidyl peptidase-4 inhibitor   12   11   5   28 
None   193   195   101   489 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 31.64  (4.4)   31.66  (4.51)   31.99  (4.39)   31.72  (4.44) 
Duration of Diabetes 
[Units: Years]
Mean (Standard Deviation)
 8.89  (5.51)   8.66  (5.59)   8.89  (6.26)   8.80  (5.69) 
Daily Dose of Metformin 
[Units: Mg]
Mean (Standard Deviation)
 2246.1  (456.8)   2244.7  (444.7)   2267.3  (427.4)   2249.8  (445.9) 
HbA1c 
[Units: Percentage of HbA1c]
Mean (Standard Deviation)
 8.08  (0.71)   8.08  (0.69)   8.13  (0.72)   8.09  (0.70) 
Fasting Plasma Glucose (FPG) 
[Units: mmol/L]
Mean (Standard Deviation)
 9.87  (2.35)   9.75  (2.32)   9.75  (2.19)   9.80  (2.31) 


  Outcome Measures

1.  Primary:   Change in HbA1c From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

2.  Secondary:   Percentage of Participants With HbA1c <7.0% or ≤6.5% at Week 30   [ Time Frame: Week 30 ]

3.  Secondary:   Change in Plasma Glucose Excursion From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

4.  Secondary:   Change in Body Weight From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

5.  Secondary:   Change in Fasting Plasma Glucose (FPG) From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

6.  Secondary:   Mean Change in 7-point Self-monitored Plasma Glucose (SMPG) Profile From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

7.  Secondary:   Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30   [ Time Frame: Week 30 ]

8.  Secondary:   Percentage of Participants Reaching HbA1c <7.0% With No Body Weight Gain at Week 30 and No Documented Symptomatic Hypoglycemia (Plasma Glucose [PG] ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period   [ Time Frame: Baseline up to Week 30 ]

9.  Secondary:   Average Daily Insulin Glargine Dose at Week 30   [ Time Frame: Week 30 ]

10.  Secondary:   Change in 2-Hour Postprandial Plasma Glucose (PPG) From Baseline to Week 30   [ Time Frame: Baseline, Week 30 ]

11.  Secondary:   Percentage of Participants Reaching HbA1c <7.0% at Week 30 With No Documented Symptomatic Hypoglycemia (PG ≤ 70 mg/dL [3.9 mmol/L]) During 30-Week Treatment Period   [ Time Frame: Baseline up to Week 30 ]

12.  Secondary:   Percentage of Participants Requiring Rescue Therapy During 30-Week Treatment Period   [ Time Frame: Baseline up to Week 30 ]

13.  Secondary:   Number of Documented Symptomatic Hypoglycemia Events Per Subject-Year   [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days) ]

14.  Secondary:   Percentage of Participants With Documented Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days) ]

15.  Secondary:   Percentage of Participants With Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 1 day after the last dose administration (median treatment exposure: 211 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: NCT02058147     History of Changes
Other Study ID Numbers: EFC12404
2013-003131-30 ( EudraCT Number )
U1111-1148-4334 ( Other Identifier: UTN )
First Submitted: February 6, 2014
First Posted: February 7, 2014
Results First Submitted: December 16, 2016
Results First Posted: February 10, 2017
Last Update Posted: May 9, 2017