We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029886
First Posted: December 10, 2009
Last Update Posted: April 9, 2015
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.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: liraglutide

  Participant Flow


  Baseline Characteristics
  Hide 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
Exenatide Once Weekly Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily Subcutaneous injection, forced titration to 1.8mg, once daily
Total Total of all reporting groups

Baseline Measures
   Exenatide Once Weekly   Liraglutide Once Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 461   450   911 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   386   360   746 
>=65 years   75   90   165 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.6  (9.43)   56.7  (9.59)   56.6  (9.51) 
Gender 
[Units: Participants]
     
Female   207   205   412 
Male   254   245   499 
Glycosylated hemoglobin (HbA1c) 
[Units: Percentage of total hemoglobin]
Mean (Standard Deviation)
 8.45  (1.014)   8.43  (0.996)   8.44  (1.004) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 90.88  (19.472)   91.13  (19.118)   91.00  (19.288) 
Background Oral Antidiabetic Agent (OAD) 
[Units: Participants]
     
Metformin (MET)   150   136   286 
Sulfonylurea (SU)   18   18   36 
Pioglitazone (PIO)   1   0   1 
MET+SU   275   277   552 
MET+PIO   16   18   34 
MET+SU+PIO   1   1   2 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Percentage of Patients Achieving HbA1c <7.0% at Week 26   [ Time Frame: Baseline, Week 26 ]

3.  Secondary:   Change in Fasting Serum Glucose From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

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

5.  Secondary:   Change in Total Cholesterol From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

6.  Secondary:   Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

7.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]

8.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]

10.  Secondary:   Assessment of Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information