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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):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT01029886
First received: December 8, 2009
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
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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  Baseline Characteristics
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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
Total Total of all reporting groups

Baseline Measures
    Exenatide Once Weekly     Liraglutide Once Daily     Total  
Number of Participants  
[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
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1.  Primary:   Change in HbA1c From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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2.  Secondary:   Percentage of Patients Achieving HbA1c <7.0% at Week 26   [ Time Frame: Baseline, Week 26 ]
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3.  Secondary:   Change in Fasting Serum Glucose From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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4.  Secondary:   Change in Body Weight From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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5.  Secondary:   Change in Total Cholesterol From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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6.  Secondary:   Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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7.  Secondary:   Ratio of Fasting Triglycerides at Week 26 to Baseline   [ Time Frame: Baseline, Week 26 ]
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8.  Secondary:   Change in Systolic Blood Pressure (SBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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9.  Secondary:   Change in Diastolic Blood Pressure (DBP) From Baseline to Week 26   [ Time Frame: Baseline, Week 26 ]
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10.  Secondary:   Assessment of Event Rate of Treatment-emergent Hypoglycemic Events   [ Time Frame: Baseline to Week 26 ]
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  Serious Adverse Events
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  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Exenatide Once Weekly Subcutaneous injection, 2mg, once weekly
Liraglutide Once Daily Subcutaneous injection, forced titration to 1.8mg, once daily

Other Adverse Events
    Exenatide Once Weekly     Liraglutide Once Daily  
Total, other (not including serious) adverse events      
# participants affected / at risk     160/461     212/450  
Gastrointestinal disorders      
Nausea * 1    
# participants affected / at risk     43/461 (9.33%)     93/450 (20.67%)  
Diarrhoea * 1    
# participants affected / at risk     28/461 (6.07%)     58/450 (12.89%)  
Vomiting * 1    
# participants affected / at risk     17/461 (3.69%)     47/450 (10.44%)  
Dyspepsia * 1    
# participants affected / at risk     11/461 (2.39%)     27/450 (6.00%)  
General disorders      
Injection site nodule * 1    
# participants affected / at risk     48/461 (10.41%)     5/450 (1.11%)  
Therapeutic response unexpected * 1    
# participants affected / at risk     11/461 (2.39%)     27/450 (6.00%)  
Infections and infestations      
Nasopharyngitis * 1    
# participants affected / at risk     31/461 (6.72%)     32/450 (7.11%)  
Metabolism and nutrition disorders      
Decreased appetite * 1    
# participants affected / at risk     17/461 (3.69%)     29/450 (6.44%)  
Nervous system disorders      
Headache * 1    
# participants affected / at risk     27/461 (5.86%)     38/450 (8.44%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 14.0



  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-877-285-4559
e-mail: clinicaltrials@amylin.com


No publications provided by Amylin Pharmaceuticals, LLC.

Publications automatically indexed to this study:


Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT01029886     History of Changes
Other Study ID Numbers: H8O-MC-GWDE
Study First Received: December 8, 2009
Results First Received: February 14, 2012
Last Updated: January 14, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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Canada: Health Canada
Czech Republic: State Institute for Drug Control
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India: Ministry of Health: Drug Control General of India (DCGI)
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: The Italian Medicines Agency
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Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
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Taiwan: Department of Health