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Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00729326
First received: August 4, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: exenatide
Drug: sitagliptin
Drug: placebo

  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 Followed By Sitagliptin Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
Sitagliptin Followed By Exenatide Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.

Participant Flow:   Overall Study
    Exenatide Followed By Sitagliptin     Sitagliptin Followed By Exenatide  
STARTED     41     42  
COMPLETED     31     33  
NOT COMPLETED     10     9  
Lost to Follow-up                 2                 0  
Physician Decision                 0                 1  
Protocol Violation                 3                 2  
Subject Decision                 4                 4  
Sponsor Decision                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Exenatide Followed By Sitagliptin Exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks. Followed by exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks.
Sitagliptin Followed By Exenatide Exenatide placebo plus sitagliptin 100mg for 1 week, then exenatide placebo plus sitagliptin 100mg for 3 weeks. Followed by exenatide 5mcg plus sitagliptin placebo for 1 week, then exenatide 10mcg plus sitagliptin placebo for 3 weeks.
Total Total of all reporting groups

Baseline Measures
    Exenatide Followed By Sitagliptin     Sitagliptin Followed By Exenatide     Total  
Number of Participants  
[units: participants]
 		  41     42     83  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     34     37     71  
>=65 years     7     5     12  
Age  
[units: years]
Mean ± Standard Deviation 		  54.7  ± 10.10     53.5  ± 9.49     54.1  ± 9.75  
Gender  
[units: participants]
 		     
Female     19     29     48  
Male     22     13     35  



  Outcome Measures
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1.  Primary:   Change in Time-averaged Glucose During a 24 Hour Period   [ Time Frame: baseline and 8 Weeks ]
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2.  Secondary:   Change in Two-hour Postprandial Glucose After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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3.  Secondary:   Change in Fasting Blood Glucose After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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4.  Secondary:   Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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5.  Secondary:   Change in Postprandial Glucagon AUC Excursion After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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6.  Secondary:   Change in Postprandial Triglyceride AUC After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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7.  Secondary:   Change in Postprandial Triglyceride AUC Excursion After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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8.  Secondary:   Change in Postprandial C-peptide AUC After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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9.  Secondary:   Change in Postprandial C-peptide AUC Excursion After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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10.  Secondary:   Change in Postprandial Insulin AUC After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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11.  Secondary:   Change in Postprandial Insulin AUC Excursion After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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12.  Secondary:   Change in Postprandial Active GLP-1 AUC After the Morning Meal   [ Time Frame: baseline and 8 Weeks ]
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13.  Secondary:   Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal   [ Time Frame: baseline and 8 Weeks ]
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14.  Secondary:   Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)   [ Time Frame: 4 Weeks ]
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15.  Secondary:   Episodes of Hypoglycemia (Baseline to Week 4)   [ Time Frame: 4 weeks ]
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16.  Secondary:   Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)   [ Time Frame: 8 weeks ]
  Show Outcome Measure 16

17.  Secondary:   Episodes of Hypoglycemia (Week 4 to Week 8)   [ Time Frame: 8 weeks ]
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18.  Secondary:   Percentage of Patients Experiencing Hypoglycemia (Overall)   [ Time Frame: 4 weeks and 8 weeks ]
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19.  Secondary:   Episodes of Hypoglycemia (Overall)   [ Time Frame: 4 weeks and 8 weeks ]
  Show Outcome Measure 19


  Serious Adverse Events
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  Other Adverse Events
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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 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
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-LILLYRX
e-mail: clinicaltrials@amylin.com


No publications provided


Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00729326     History of Changes
Other Study ID Numbers: H8O-US-GWCV
Study First Received: August 4, 2008
Results First Received: October 12, 2010
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board