Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure (S-001)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Michael Fowler, Stanford University
ClinicalTrials.gov Identifier:
NCT00657280
First received: April 9, 2008
Last updated: December 4, 2014
Last verified: December 2014
Results First Received: May 13, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure, Congestive
Intervention: Drug: Sitagliptin

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Sitagliptin There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls

Participant Flow:   Overall Study
    Sitagliptin  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Adult patients diagnosis of nonischemic dilated cardiomyopathy with Class I-III symptoms. all patients were required to have been on a stable comprehensive heart failure regimen for at least three months, including therapy with beta-blockers and angiotensin-converting-enzyme inhibitors or angiotensin-receptor-blockers unless they were intolerant.

Reporting Groups
  Description
Sitagliptin There is only one group. All the participants took the Sitagliptin.

Baseline Measures
    Sitagliptin  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Full Range)
  51    (43 to 60)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     0  
Gender  
[units: participants]
 
Female     3  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures

1.  Primary:   Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan   [ Time Frame: 30 days ]

2.  Primary:   Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy   [ Time Frame: 2008-2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy   [ Time Frame: 2010-2012 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy   [ Time Frame: 4 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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. Michael Fowler Director of the Heart Failure
Organization: Stanford Hospital and clinics
phone: 650-721-5540
e-mail: mfowler@stanford.edu


No publications provided


Responsible Party: Michael Fowler, Stanford University
ClinicalTrials.gov Identifier: NCT00657280     History of Changes
Other Study ID Numbers: SU-04082008-1088
Study First Received: April 9, 2008
Results First Received: May 13, 2014
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board