Trial Outcomes & Findings for Study of the Effect of Sitagliptin on Glucose (Sugar) Metabolism in Patients With Heart Failure (NCT NCT00657280)

Results Overview

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

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

16 participants

Primary outcome timeframe

30 days

Results posted on

2014-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Sitagliptin There is only one group. All the participants took Sitagliptin 100mg daily and acted as their own controls
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sitagliptin n=12 Participants There is only one group. All the participants took the Sitagliptin.
Age, Continuous	51 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Scans were lost in 4 participants

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

Outcome measures

Outcome measures
Measure	Sitagliptin n=12 Participants There is only one group. All the participants took the Sitagliptin.
Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan Baseline	3.4 SUV Interval 2.0 to 6.0
Determine the Effects of Sitagliptin on Myocardial Glucose Uptake Measured by Myocardial PET Scan 30 days	4.1 SUV Interval 3.0 to 6.0

PRIMARY outcome

Timeframe: 2008-2012

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2010-2012

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

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.

Outcome measures

Outcome data not reported

Adverse Events

Sitagliptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Fowler Director of the Heart Failure

Stanford Hospital and clinics

Phone: 650-721-5540

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place