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Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure

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ClinicalTrials.gov Identifier: NCT00799435
Recruitment Status : Terminated (Inability to recruit adequate Sample Size who met the entry criteria)
First Posted : November 27, 2008
Results First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Aguilar, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes Mellitus, Type 2
Heart Failure, Diastolic
Intervention Drug: Exenatide
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Exenatide Group
Hide Arm/Group Description Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.

Participants will receive exenatide for 12 weeks.

Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Usual Care Exenatide Total
Hide Arm/Group Description Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.

Participants will receive exenatide for 12 weeks.

Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
1
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
1
 100.0%
2
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 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
1
 100.0%
0
   0.0%
1
  50.0%
White
0
   0.0%
1
 100.0%
1
  50.0%
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%
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1
 100.0%
1
 100.0%
2
 100.0%
[1]
Measure Description: texas
1.Primary Outcome
Title Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Hide Description [Not Specified]
Time Frame Measured at Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Exenatide
Hide Arm/Group Description:
Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.

Participants will receive exenatide for 12 weeks.

Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Changes in Left Ventricular Diastolic Stiffness, Serum Levels of Advanced Glycation End Products, Serum Biomarkers of Collagen Synthesis, and Serum Levels of Brain Natriuretic Peptide
Hide Description [Not Specified]
Time Frame Measured at Week 12
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care Exenatide
Hide Arm/Group Description Participants will receive usual care for 12 weeks. The care will be dictated by the primary physician and/or diabetologist caring for the participant. Efforts will be made to ensure that all participants receive standard measures as indicated by guidelines, with a particular emphasis on blood pressure control and glucose control.

Participants will receive exenatide for 12 weeks.

Exenatide: 5 μg of exenatide subcutaneously twice a day for 4 weeks, followed by 10 μg of exenatide subcutaneously twice a day for an additional 8 weeks

All-Cause Mortality
Standard Care Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Care Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care Exenatide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
The study was stopped due to difficulties enrolling and fulfilling entry criteria
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: David Aguilar, MD
Organization: Baylor
Phone: 713-798-0280
Responsible Party: David Aguilar, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00799435     History of Changes
Other Study ID Numbers: 613
1K01HL092585 ( U.S. NIH Grant/Contract )
1K01HL092585-01 ( U.S. NIH Grant/Contract )
H-22906 ( Other Identifier: Baylor College of Medicine )
First Submitted: November 26, 2008
First Posted: November 27, 2008
Results First Submitted: August 25, 2017
Results First Posted: September 21, 2017
Last Update Posted: September 21, 2017