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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01029886
First received: December 8, 2009
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: February 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide once weekly
Drug: liraglutide

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily Subcutaneous injection, forced titration to 1.8mg, once daily

Participant Flow:   Overall Study
    Exenatide Once Weekly     Liraglutide Once Daily  
STARTED     461     451  
Intent to Treat (ITT)     461     450  
COMPLETED     400     391  
NOT COMPLETED     61     60  
Adverse Event                 12                 25  
Lost to Follow-up                 1                 0  
Physician Decision                 2                 6  
Protocol Violation                 17                 5  
Withdrawal by Subject                 8                 18  
Entry Criteria Not Met                 13                 5  
Sponsor Decision                 1                 0  
Loss Glucose Control                 7                 1  



  Baseline Characteristics


  Outcome Measures
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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
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Exenatide Once Weekly     Liraglutide Once Daily  
Total, serious adverse events      
# participants affected / at risk     13/461 (2.82%)     7/450 (1.56%)  
Cardiac disorders      
Coronary artery disease * 1    
# participants affected / at risk     1/461 (0.22%)     1/450 (0.22%)  
Myocardial infarction * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Atrial fibrillation * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Ear and labyrinth disorders      
Hearing impaired * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Gastrointestinal disorders      
Gastrointestinal disorder * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Gastrointestinal haemorrhage * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Pancreatitis acute * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Constipation * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Diarrhoea * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Vomiting * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
General disorders      
Impaired healing * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Chest pain * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Hepatobiliary disorders      
Cholecystitis acute * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Cholelithiasis * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Immune system disorders      
Anaphylactic reaction * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Infections and infestations      
Appendicitis * 1    
# participants affected / at risk     2/461 (0.43%)     0/450 (0.00%)  
Injury, poisoning and procedural complications      
Joint dislocation * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Patella fracture * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Musculoskeletal and connective tissue disorders      
Intervertebral disc protrusion * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Prostate cancer * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Spinal cord neoplasm * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
Nervous system disorders      
Cerebrovascular accident * 1    
# participants affected / at risk     1/461 (0.22%)     1/450 (0.22%)  
Brain stem infarction * 1    
# participants affected / at risk     0/461 (0.00%)     1/450 (0.22%)  
Psychiatric disorders      
Depression * 1    
# participants affected / at risk     1/461 (0.22%)     0/450 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0




  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