Trial Outcomes & Findings for Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure (NCT NCT00799435)
NCT ID: NCT00799435
Last Updated: 2020-09-04
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
Measured at Week 12
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
Control Group
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.
|
Exenatide Group
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 Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Use of Exenatide in People With Type 2 Diabetes and Diastolic Heart Failure
Baseline characteristics by cohort
| Measure |
Usual Care
n=1 Participants
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.
|
Exenatide
n=1 Participants
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
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 12Population: For the usual care, data were obtained for only person, but data was collected only at baseline and follow-up data were not collected. For the exenatide arm, data were collected for only one participant at baseline and follow-up.
Outcome measures
| Measure |
Usual Care
n=1 Participants
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.
|
Exenatide
n=1 Participants
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
|
|---|---|---|
|
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Baseline Pulse Wave Velocity
|
11.4 m/sec
Standard Deviation 0
|
9.3 m/sec
Standard Deviation 0
|
|
Change in Aortic Stiffness, as Measured by the Change in the Mean Aortic Pulse Wave Velocity
Follow-up Pulse Wave Velocity
|
NA m/sec
Standard Deviation NA
Could not obtain technically obtain an adequate follow-up PWV reading
|
10.2 m/sec
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Measured at Week 12Population: Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
Given the cessation of trials, the biomarkers analyses and diastolic function measures were not performed.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exenatide
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place