Trial Outcomes & Findings for The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes (NCT NCT01181986)
NCT ID: NCT01181986
Last Updated: 2014-05-20
Results Overview
Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)
Results posted on
2014-05-20
Participant Flow
Participant milestones
| Measure |
Exenatide Then Placebo (Sub-study 1)
Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
|
Placebo Then Exenatide (Sub-study 1)
Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
|
Exenatide IV (Sub-study 2)
Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
|
|---|---|---|---|
|
Phase 1
STARTED
|
19
|
23
|
34
|
|
Phase 1
Saline+Exenatide
|
0
|
0
|
32
|
|
Phase 1
Saline+Placebo
|
0
|
0
|
33
|
|
Phase 1
Exendin-9+Exenatide
|
0
|
0
|
33
|
|
Phase 1
COMPLETED
|
18
|
22
|
32
|
|
Phase 1
NOT COMPLETED
|
1
|
1
|
2
|
|
Phase 2
STARTED
|
18
|
22
|
0
|
|
Phase 2
COMPLETED
|
18
|
18
|
0
|
|
Phase 2
NOT COMPLETED
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
Exenatide Then Placebo (Sub-study 1)
Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
|
Placebo Then Exenatide (Sub-study 1)
Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
|
Exenatide IV (Sub-study 2)
Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
|
|---|---|---|---|
|
Phase 1
Lost to Follow-up
|
0
|
1
|
1
|
|
Phase 1
Adverse Event
|
0
|
0
|
1
|
|
Phase 1
Protocol Violation
|
1
|
0
|
0
|
|
Phase 2
Adverse Event
|
0
|
3
|
0
|
|
Phase 2
Medical condition
|
0
|
1
|
0
|
Baseline Characteristics
The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes
Baseline characteristics by cohort
| Measure |
Sub-study 1: Exenatide SC
n=42 Participants
Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
|
Sub-study 2: Exenatide IV
n=34 Participants
Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 6 • n=5 Participants
|
60 years
STANDARD_DEVIATION 6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body mass index
|
33 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
33 kg/m^2
STANDARD_DEVIATION 12 • n=7 Participants
|
33 kg/m^2
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Glycated hemoglobin
|
6.6 %
STANDARD_DEVIATION 0.9 • n=5 Participants
|
6.1 %
STANDARD_DEVIATION 0.5 • n=7 Participants
|
6.4 %
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Diabetes duration (years)
|
6 years
n=5 Participants
|
0 years
n=7 Participants
|
6 years
n=5 Participants
|
|
Systolic BP
|
128 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
125 mmHg
STANDARD_DEVIATION 12 • n=7 Participants
|
127 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Diastolic BP (mmHg)
|
78 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
80 mmHg
STANDARD_DEVIATION 8 • n=7 Participants
|
79 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
History of hypertension
Yes
|
33 participants
n=5 Participants
|
16 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
History of hypertension
No
|
9 participants
n=5 Participants
|
18 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Lipid-lowering therapy
Yes
|
5 participants
n=5 Participants
|
15 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Lipid-lowering therapy
No
|
37 participants
n=5 Participants
|
19 participants
n=7 Participants
|
56 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2)Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models.
Outcome measures
| Measure |
Exenatide (Subs-study 1)
n=36 Participants
Exenatide: Exenatide 5-10 ug sc BID/10 days
|
Placebo (Sub-study 1)
n=36 Participants
Placebo sc BID for 10 days
|
Saline+Exenatide (Sub-study 2)
n=32 Participants
Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
|
Saline+Placebo (Sub-study 2)
n=32 Participants
Infusion of saline (min 0-75), added placebo infusion (min 30-75)
|
Exendin-9+Exenatide (Sub-study 2)
n=32 Participants
Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
|
|---|---|---|---|---|---|
|
Reactive Hyperemia Index (RHI)
|
1.90 ratio
Standard Error 0.005
|
1.79 ratio
Standard Error 0.05
|
2.24 ratio
Standard Error 0.07
|
1.95 ratio
Standard Error 0.07
|
1.99 ratio
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6 and 8 hours post-study drug on day 11Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.
Outcome measures
| Measure |
Exenatide (Subs-study 1)
n=36 Participants
Exenatide: Exenatide 5-10 ug sc BID/10 days
|
Placebo (Sub-study 1)
n=36 Participants
Placebo sc BID for 10 days
|
Saline+Exenatide (Sub-study 2)
Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
|
Saline+Placebo (Sub-study 2)
Infusion of saline (min 0-75), added placebo infusion (min 30-75)
|
Exendin-9+Exenatide (Sub-study 2)
Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
|
|---|---|---|---|---|---|
|
Plasma Triglycerides
|
175 mg/dl
Standard Error 14
|
230 mg/dl
Standard Error 14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 2, 4, 6, and 8 hours post-study drug on day 11Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence.
Outcome measures
| Measure |
Exenatide (Subs-study 1)
n=36 Participants
Exenatide: Exenatide 5-10 ug sc BID/10 days
|
Placebo (Sub-study 1)
n=36 Participants
Placebo sc BID for 10 days
|
Saline+Exenatide (Sub-study 2)
Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
|
Saline+Placebo (Sub-study 2)
Infusion of saline (min 0-75), added placebo infusion (min 30-75)
|
Exendin-9+Exenatide (Sub-study 2)
Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
|
|---|---|---|---|---|---|
|
Plasma Glucose
|
115 mg/dl
Standard Error 5
|
136 mg/dl
Standard Error 5
|
—
|
—
|
—
|
Adverse Events
Exenatide SC (Sub-study 1)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo SC (Sub-study 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Saline+Exenatide IV (Sub-study 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline+Placebo (Sub-study 2)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Exendin-9+Exenatide IV (Sub-study 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide SC (Sub-study 1)
n=41 participants at risk
Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
|
Placebo SC (Sub-study 1)
n=41 participants at risk
Placebo sc BID/10days, AM dose and meal test on day 11
|
Saline+Exenatide IV (Sub-study 2)
n=32 participants at risk
Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
|
Saline+Placebo (Sub-study 2)
n=33 participants at risk
Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
|
Exendin-9+Exenatide IV (Sub-study 2)
n=33 participants at risk
Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/41
|
0.00%
0/34
|
0.00%
0/32
|
3.0%
1/33 • Number of events 1
|
0.00%
0/33
|
Other adverse events
| Measure |
Exenatide SC (Sub-study 1)
n=41 participants at risk
Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
|
Placebo SC (Sub-study 1)
n=41 participants at risk
Placebo sc BID/10days, AM dose and meal test on day 11
|
Saline+Exenatide IV (Sub-study 2)
n=32 participants at risk
Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
|
Saline+Placebo (Sub-study 2)
n=33 participants at risk
Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
|
Exendin-9+Exenatide IV (Sub-study 2)
n=33 participants at risk
Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.1%
14/41 • Number of events 14
|
4.9%
2/41 • Number of events 2
|
0.00%
0/32
|
0.00%
0/33
|
0.00%
0/33
|
|
General disorders
Headache
|
2.4%
1/41 • Number of events 1
|
2.4%
1/41 • Number of events 1
|
0.00%
0/32
|
0.00%
0/33
|
0.00%
0/33
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • Number of events 1
|
0.00%
0/41
|
0.00%
0/32
|
0.00%
0/33
|
0.00%
0/33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place