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Impact of Exenatide on Cardiovascular Exercise Performance in Type 2 Diabetes (Exenatide)

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ClinicalTrials.gov Identifier: NCT01364584
Recruitment Status : Completed
First Posted : June 2, 2011
Results First Posted : July 9, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Type 2 Diabetes
Interventions Drug: Exenatide
Drug: Placebo
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Period Title: Overall Study
Started 11 12
Completed 11 12
Not Completed 0 0
Arm/Group Title Exenatide Placebo Total
Hide Arm/Group Description

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Total of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 12 participants 23 participants
64  (7) 64  (1) 64  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
4
  36.4%
7
  58.3%
11
  47.8%
Male
7
  63.6%
5
  41.7%
12
  52.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants 12 participants 23 participants
11
 100.0%
12
 100.0%
23
 100.0%
Body Mass (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 11 participants 12 participants 23 participants
101.7  (5.3) 87.9  (3.3) 93.4  (16.1)
Body Mass Index (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kilograms per meter squared
Number Analyzed 11 participants 12 participants 23 participants
33.9  (1.0) 31.3  (1.2) 32.3  (3.9)
Body Fat (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 11 participants 12 participants 23 participants
37.7  (2.3) 35.7  (2.2) 36.7  (7.15)
Lean Mass (kg)  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 11 participants 12 participants 23 participants
61.9  (3.9) 55.8  (2.8) 58.1  (11.6)
Fasting Glucose (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 11 participants 12 participants 23 participants
170.5  (24.2) 127.9  (8.0) 147.6  (59.9)
Fasting Insulin (μU/ml)  
Mean (Standard Deviation)
Unit of measure:  Microunits per milliliter
Number Analyzed 11 participants 12 participants 23 participants
29.0  (3.7) 34.6  (6.4) 31.0  (15.1)
HbA1c (%)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycated hemoglobin
Number Analyzed 11 participants 12 participants 23 participants
7.3  (1.1) 7.2  (0.4) 7.2  (1.1)
Total Cholesterol (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 11 participants 12 participants 23 participants
156.3  (9.8) 175.3  (11.7) 165.2  (34.9)
LDL Cholesterol (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 11 participants 12 participants 23 participants
93.8  (6.2) 97.6  (7.4) 94.4  (22.1)
Triglycerides (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 11 participants 12 participants 23 participants
156.8  (18.3) 217.8  (58.0) 190.1  (136.9)
Glycerol (mg/dl)  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 11 participants 12 participants 23 participants
1.21  (0.5) 1.14  (0.5) 1.16  (0.5)
Free Fatty Acids (mmol/L)  
Mean (Standard Deviation)
Unit of measure:  Millimoles per liter
Number Analyzed 11 participants 12 participants 23 participants
580.8  (76.3) 500.5  (67.8) 546.3  (228.2)
VO2peak (ml/kg/min)  
Mean (Standard Deviation)
Unit of measure:  Milliliters per kilogram per minute
Number Analyzed 11 participants 12 participants 23 participants
17.5  (1.0) 15.4  (0.9) 16.4  (3.1)
VO2peak (ml/min)  
Mean (Standard Deviation)
Unit of measure:  Milliliters per minute
Number Analyzed 11 participants 12 participants 23 participants
1783  (129) 1363  (95) 1554  (415)
VO2 kinetics tau (sec)  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 11 participants 12 participants 23 participants
78.2  (6.8) 63.3  (5.9) 71.9  (19.1)
Circumferential Strain   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage difference in circumferences
Number Analyzed 11 participants 12 participants 23 participants
-23.7  (5.5) -23.5  (5.0) -23.6  (5.3)
[1]
Measure Description: Measured via echocardiography, circumferential strain is calculated as the change in circumference of both the endocardium and the epicardium as compared to the relaxed circumference of those regions.
Longitudinal Strain   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage difference in lengths
Number Analyzed 11 participants 12 participants 23 participants
-17.1  (3.9) -19.3  (2.3) -18.2  (3.4)
[1]
Measure Description: Measured via echocardiography, longitudinal strain is calculated as the change in length of both the endocardium and the epicardium as compared to the relaxed length of those regions.
Stroke Volume (ml/beat)  
Mean (Standard Deviation)
Unit of measure:  Milliliters per beat
Number Analyzed 11 participants 12 participants 23 participants
79.2  (22.7) 82.5  (23.1) 81.5  (23.1)
1.Primary Outcome
Title Peak Oxygen Consumption (VO2 Peak)
Hide Description Subjects' peak oxygen consumption (VO2 peak) will be tested on a stationary bike before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: milliliters per kilogram per minute
16.6  (1.1) 16.1  (1.1)
2.Secondary Outcome
Title Oxygen Uptake Kinetics Steady State Tau
Hide Description Time to steady state oxygen consumption will be assessed in subject before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: seconds
71.4  (8.5) 67.2  (2.7)
3.Secondary Outcome
Title Change From Baseline in Arterial Stiffness
Hide Description Pulse wave velocity will be measured via sphygmocor before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data unable to be collected on all participants, hence the difference between the overall number of participants analyzed here and the actual number of participants who completed the study
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed inject-able pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 6 7
Mean (Standard Deviation)
Unit of Measure: meters/second
-1.23  (1.27) 0.37  (0.89)
4.Secondary Outcome
Title Change From Baseline in Peak Dilation of Brachial Artery Diameter
Hide Description Change in the response of the brachial artery to hyperemia will be assessed before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: millimeters
Pre-Intervention (Baseline) 0.193  (0.045) 0.192  (0.046)
Post-Intervention (3 months) 0.226  (0.057) 0.151  (0.026)
5.Secondary Outcome
Title Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise
Hide Description Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Echocardiographic Measures - Circumferential Strain
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: % difference in circumferences
-25.6  (1.78) -22.6  (1.4)
7.Secondary Outcome
Title Echocardiographic Measures - Longitudinal Strain
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: % difference in lengths
-18.5  (1.2) -18.3  (0.8)
8.Secondary Outcome
Title Echocardiographic Measures - Stroke Volume
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: mL/beat
93.3  (2.8) 80.7  (1.9)
9.Secondary Outcome
Title Echocardiographic Measures - Mitral Valve E Wave Velocity
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: centimeters/second
0.61  (0.06) 0.78  (0.06)
10.Secondary Outcome
Title Echocardiographic Measures - Mitral Valve E:A Wave Velocity
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: centimeters/second
0.85  (0.09) 0.82  (0.06)
11.Secondary Outcome
Title Echocardiographic Measures - Mitral Valve Deceleration Time
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: milliseconds
234.6  (17.0) 239.8  (14.6)
12.Secondary Outcome
Title Echocardiographic Measures - Septal E'
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: centimeters/second
0.08  (0.01) 0.07  (0.01)
13.Secondary Outcome
Title Echocardiographic Measures - Septal E:E'
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: ratio
8.3  (0.9) 12.6  (1.4)
14.Secondary Outcome
Title Echocardiographic Measures - Lateral E'
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: centimeters/second
0.09  (0.01) 0.09  (0.01)
15.Secondary Outcome
Title Echocardiographic Measures - Lateral E:E'
Hide Description Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication or placebo.
Time Frame Baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description:

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: ratio
6.7  (0.6) 8.4  (1.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Exenatide Placebo
Hide Arm/Group Description

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of exenatide for 2.5 months

Exenatide: Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)

Pre-dosed injectable pen (an automatic device which injects under the skin) 10 mcg twice a day of placebo for 2.5 months

Placebo: Subcutaneous injection 2.5 mcg-10 mcg BID

All-Cause Mortality
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/11 (27.27%)   0/12 (0.00%) 
Blood and lymphatic system disorders     
Eosinophil count increased [1]  1/11 (9.09%)  0/12 (0.00%) 
Renal and urinary disorders     
Renal Neoplasm (Tumor on base of kidney) [2]  1/11 (9.09%)  0/12 (0.00%) 
Bladder Papilloma [3]  1/11 (9.09%)  0/12 (0.00%) 
[1]
A white male patient was hospitalized for eosinophil count increased (grade 1) while enrolled in the study. The patient initiated blinded study therapy on 04.23.13. Study therapy was discontinued due to the event, with last dose received on 10.22.13.
[2]
A 60-year-old Caucasian male patient was diagnosed with a tumor on the base of the kidney while enrolled in the study. No action was taken regarding the blinded study therapy due to the event.
[3]
A 64-year-old white female patient was diagnosed with urothelial papilloma while enrolled in the study. Study therapy was held due to the event. The event was classified as a benign neoplasm with the bladder as the site of primary malignancy.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exenatide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/12 (0.00%) 
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: Judith G Regensteiner, PhD
Organization: University of Colorado School of Medicine
Phone: 303-724-2247
EMail: judy.regensteiner@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01364584     History of Changes
Other Study ID Numbers: 10-0438
First Submitted: May 24, 2011
First Posted: June 2, 2011
Results First Submitted: June 29, 2017
Results First Posted: July 9, 2018
Last Update Posted: August 15, 2018