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

NCT00657280 | Completed Early Phase 1 Results DMC

• 1 other identifier: SU-04082008-1088
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. This study will also investigate the effect of sitagliptin on the body's use of sugar, and of the effect of sitagliptin on blood flow to the heart.

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (2)

• Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan

  This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication. Baseline glucose uptake scans will be compared with the scans on sitagliptin thirty days after baseline

  30 days

• Determine the Effects of Sitagliptin on Myocardial Glucose Uptake in Patients With Nonischemic Cardiomyopathy

  This study will investigate the effects of sitagliptin, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. We hope to determine whether improving the heart's ability to use glucose in the blood may help improve the function of the heart as well. If so, this may suggest that even people who do not have frank diabetes but who do have heart failure may benefit from using this medication.

  2008-2012

Secondary Outcomes (2)

• Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy

  2010-2012

• Determine the Effects of Sitagliptin on Microvascular Function in Patients With Nonischemic Cardiomyopathy

  4 years

Study Arms (1)

All subjects recieve Sitagliptin

EXPERIMENTAL

All subjects are aware of what they are taking. Nobody is blinded in this study. study

Drug: Sitagliptin

Interventions

Sitagliptin DRUG

No one is blinded to the treatments.

Also known as: Januvia

All subjects recieve Sitagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of nonischemic dilated cardiomyopathy, current NYHA class I-III congestive heart failure
• Treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ACE-inhibitors or angiotensin receptor blockers unless intolerant)
• Age \> 18 yrs

You may not qualify if:

• Cardiomyopathy primarily due to one of the following:
• Ischemic heart disease
• Primary valvular lesion
• Hypertrophic cardiomyopathy
• Cardiac resynchronization within the last 3 months
• Calculated creatinine clearance \<30 ml/min or end-stage renal disease on dialysis. Creatinine clearance will be determined by the Cockcroft-Gault formula.
• Diagnosis of diabetes mellitus by:
• Diabetes previously diagnosed per patient history
• or more fasting glucose values \> 125 mg/dl
• History of heart transplantation
• Pregnancy or active breast feeding
• Hospitalization for decompensated heart failure within 30 days prior to enrollment.

Sponsors & Collaborators

• Stanford University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Results Point of Contact

• Title: Dr. Michael Fowler Director of the Heart Failure
• Organization: Stanford Hospital and clinics

mfowler@stanford.edu

650-721-5540

Study Officials

• Michael B Fowler

  Stanford University

  PRINCIPAL INVESTIGATOR

• Ronald M. Witteles MD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 9, 2008
• First Posted: April 14, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: December 5, 2014
• Results First Posted: December 5, 2014

Record last verified: 2014-12

Locations

US (1)