Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01181986
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : April 28, 2014
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
American Diabetes Association
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Juraj Koska, Carl T. Hayden VA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide Then Placebo (Sub-study 1) Placebo Then Exenatide (Sub-study 1) Exenatide IV (Sub-study 2)
Hide Arm/Group Description 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. 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. Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
Period Title: Phase 1
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
Reason Not Completed
Lost to Follow-up             0             1             1
Adverse Event             0             0             1
Protocol Violation             1             0             0
[1]
N/A for this arm
Period Title: Phase 2
Started 18 22 0 [1]
Completed 18 18 0
Not Completed 0 4 0
Reason Not Completed
Adverse Event             0             3             0
Medical condition             0             1             0
[1]
N/A for Sub-study 2
Arm/Group Title Sub-study 1: Exenatide SC Sub-study 2: Exenatide IV Total
Hide Arm/Group Description Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study Total of all reporting groups
Overall Number of Baseline Participants 42 34 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 34 participants 76 participants
62  (6) 60  (6) 61  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 76 participants
Female
0
   0.0%
2
   5.9%
2
   2.6%
Male
42
 100.0%
32
  94.1%
74
  97.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  14.3%
5
  14.7%
11
  14.5%
White
36
  85.7%
29
  85.3%
65
  85.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 42 participants 34 participants 76 participants
33  (6) 33  (12) 33  (9)
Glycated hemoglobin  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 42 participants 34 participants 76 participants
6.6  (0.9) 6.1  (0.5) 6.4  (0.8)
Diabetes duration (years)  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 42 participants 34 participants 76 participants
6
(1 to 9)
0
(0 to 1)
6
(1 to 9)
Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 42 participants 34 participants 76 participants
128  (8) 125  (12) 127  (14)
Diastolic BP (mmHg)  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 42 participants 34 participants 76 participants
78  (8) 80  (8) 79  (8)
History of hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 76 participants
Yes 33 16 49
No 9 18 27
Lipid-lowering therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants 34 participants 76 participants
Yes 5 15 20
No 37 19 56
1.Primary Outcome
Title Reactive Hyperemia Index (RHI)
Hide Description Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.
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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide (Subs-study 1) Placebo (Sub-study 1) Saline+Exenatide (Sub-study 2) Saline+Placebo (Sub-study 2) Exendin-9+Exenatide (Sub-study 2)
Hide Arm/Group Description:
Exenatide: Exenatide 5-10 ug sc BID/10 days
Placebo sc BID for 10 days
Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
Infusion of saline (min 0-75), added placebo infusion (min 30-75)
Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
Overall Number of Participants Analyzed 36 36 32 32 32
Least Squares Mean (Standard Error)
Unit of Measure: ratio
1.90  (0.005) 1.79  (0.05) 2.24  (0.07) 1.95  (0.07) 1.99  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Subs-study 1), Placebo (Sub-study 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for treatment sequence, group (diabetes duration) and time.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Saline+Exenatide (Sub-study 2), Saline+Placebo (Sub-study 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for treatment sequence.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Saline+Exenatide (Sub-study 2), Exendin-9+Exenatide (Sub-study 2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for treatment sequence.
2.Secondary Outcome
Title Plasma Triglycerides
Hide Description Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.
Time Frame 0, 2, 4, 6 and 8 hours post-study drug on day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide (Sub-study 1) Placebo (Sub-study 1)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 36 36
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
175  (14) 230  (14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Sub-study 1), Placebo (Sub-study 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Adjusted for treatment sequence and diabetes duration group.
3.Secondary Outcome
Title Plasma Glucose
Hide Description Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.
Time Frame 0, 2, 4, 6, and 8 hours post-study drug on day 11
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide (Sub-study 1) Placebo (Sub-study 1)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 36 36
Least Squares Mean (Standard Error)
Unit of Measure: mg/dl
115  (5) 136  (5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Exenatide (Sub-study 1), Placebo (Sub-study 1)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide SC (Sub-study 1) Placebo SC (Sub-study 1) Saline+Exenatide IV (Sub-study 2) Saline+Placebo (Sub-study 2) Exendin-9+Exenatide IV (Sub-study 2)
Hide Arm/Group Description Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11 Placebo sc BID/10days, AM dose and meal test on day 11 Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75) Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75) Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
All-Cause Mortality
Exenatide SC (Sub-study 1) Placebo SC (Sub-study 1) Saline+Exenatide IV (Sub-study 2) Saline+Placebo (Sub-study 2) Exendin-9+Exenatide IV (Sub-study 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Exenatide SC (Sub-study 1) Placebo SC (Sub-study 1) Saline+Exenatide IV (Sub-study 2) Saline+Placebo (Sub-study 2) Exendin-9+Exenatide IV (Sub-study 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/41 (0.00%)      0/32 (0.00%)      1/33 (3.03%)      0/33 (0.00%)    
Cardiac disorders           
Acute myocardial infarction * [1]  0/41 (0.00%)  0 0/34 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
The event occured 13 days after the test visit during which patient received intravenous infusion of saline with placebo. The event was considered unrelated to the study per IRB decision.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide SC (Sub-study 1) Placebo SC (Sub-study 1) Saline+Exenatide IV (Sub-study 2) Saline+Placebo (Sub-study 2) Exendin-9+Exenatide IV (Sub-study 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/41 (39.02%)      3/41 (7.32%)      0/32 (0.00%)      0/33 (0.00%)      0/33 (0.00%)    
Gastrointestinal disorders           
Nausea   14/41 (34.15%)  14 2/41 (4.88%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0
Diarrhea   1/41 (2.44%)  1 0/41 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0
General disorders           
Headache   1/41 (2.44%)  1 1/41 (2.44%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Juraj Koska
Organization: Phoenix VA Health Care System
Phone: 602-277-5551 ext 7685
EMail: juraj.koska@va.gov
Layout table for additonal information
Responsible Party: Juraj Koska, Carl T. Hayden VA Medical Center
ClinicalTrials.gov Identifier: NCT01181986    
Other Study ID Numbers: 1-10-CT-31
First Submitted: August 13, 2010
First Posted: August 16, 2010
Results First Submitted: December 26, 2013
Results First Posted: April 28, 2014
Last Update Posted: May 20, 2014