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The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes

This study has been completed.
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier:
NCT01181986
First received: August 13, 2010
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: December 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Exenatide SC
Drug: Exenatide IV
Drug: Placebo SC
Drug: Exendin-9
Drug: Placebo IV

  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
No text entered.

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 Then Placebo (Sub-study 1) Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
Placebo Then Exenatide (Sub-study 1) Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
Exenatide IV (Sub-study 2) Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo

Participant Flow for 2 periods

Period 1:   Phase 1
    Exenatide Then Placebo (Sub-study 1)     Placebo Then Exenatide (Sub-study 1)     Exenatide IV (Sub-study 2)  
STARTED     19     23     34  
Saline+Exenatide     0 [1]   0 [1]   32  
Saline+Placebo     0 [1]   0 [1]   33  
Exendin-9+Exenatide     0 [1]   0 [1]   33  
COMPLETED     18     22     32  
NOT COMPLETED     1     1     2  
Lost to Follow-up                 0                 1                 1  
Adverse Event                 0                 0                 1  
Protocol Violation                 1                 0                 0  
[1] N/A for this arm

Period 2:   Phase 2
    Exenatide Then Placebo (Sub-study 1)     Placebo Then Exenatide (Sub-study 1)     Exenatide IV (Sub-study 2)  
STARTED     18     22     0 [1]
COMPLETED     18     18     0  
NOT COMPLETED     0     4     0  
Adverse Event                 0                 3                 0  
Medical condition                 0                 1                 0  
[1] N/A for Sub-study 2



  Baseline Characteristics
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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
Sub-study 1: Exenatide SC Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
Sub-study 2: Exenatide IV Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
Total Total of all reporting groups

Baseline Measures
    Sub-study 1: Exenatide SC     Sub-study 2: Exenatide IV     Total  
Number of Participants  
[units: participants]
  42     34     76  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 6     60  ± 6     61  ± 6  
Gender  
[units: participants]
     
Female     0     2     2  
Male     42     32     74  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     5     11  
White     36     29     65  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Body mass index  
[units: kg/m^2]
Mean ± Standard Deviation
  33  ± 6     33  ± 12     33  ± 9  
Glycated hemoglobin  
[units: %]
Mean ± Standard Deviation
  6.6  ± 0.9     6.1  ± 0.5     6.4  ± 0.8  
Diabetes duration (years)  
[units: years]
Median ( Inter-Quartile Range )
  6  
  ( 1 to 9 )  
  0  
  ( 0 to 1 )  
  6  
  ( 1 to 9 )  
Systolic BP  
[units: mmHg]
Mean ± Standard Deviation
  128  ± 8     125  ± 12     127  ± 14  
Diastolic BP (mmHg)  
[units: mmHg]
Mean ± Standard Deviation
  78  ± 8     80  ± 8     79  ± 8  
History of hypertension  
[units: participants]
     
Yes     33     16     49  
No     9     18     27  
Lipid-lowering therapy  
[units: participants]
     
Yes     5     15     20  
No     37     19     56  



  Outcome Measures
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1.  Primary:   Reactive Hyperemia Index (RHI)   [ Time Frame: 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2) ]

2.  Secondary:   Plasma Triglycerides   [ Time Frame: 0, 2, 4, 6 and 8 hours post-study drug on day 11 ]

3.  Secondary:   Plasma Glucose   [ Time Frame: 0, 2, 4, 6, and 8 hours post-study drug on day 11 ]


  Serious Adverse Events


  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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Juraj Koska
Organization: Phoenix VA Health Care System
phone: 602-277-5551 ext 7685
e-mail: juraj.koska@va.gov


No publications provided


Responsible Party: Juraj Koska, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier: NCT01181986     History of Changes
Other Study ID Numbers: 1-10-CT-31
Study First Received: August 13, 2010
Results First Received: December 26, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration