Trial Outcomes & Findings for A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes (NCT NCT00516074)
NCT ID: NCT00516074
Last Updated: 2015-04-07
Results Overview
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
12 weeks
Results posted on
2015-04-07
Participant Flow
Participant milestones
| Measure |
Exenatide BID
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
26
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Exenatide BID
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Subject Decision
|
4
|
2
|
|
Overall Study
Loss of Glucose Control
|
2
|
0
|
Baseline Characteristics
A Study to Assess the Effect of Exenatide Treatment on Mean 24-Hour Heart Rate in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Exenatide BID
n=28 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=26 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
56.62 years
STANDARD_DEVIATION 10.90 • n=5 Participants
|
54.14 years
STANDARD_DEVIATION 10.13 • n=7 Participants
|
55.43 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in average heart rate measured over 24 hours by an ambulatory blood pressure monitor.
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Mean 24-hour Heart Rate From Baseline to Endpoint
Baseline (Week 0)
|
74.83 beats per minute
Standard Error 2.04
|
74.47 beats per minute
Standard Error 2.08
|
|
Change in Mean 24-hour Heart Rate From Baseline to Endpoint
Change at endpoint (Week 12)
|
2.14 beats per minute
Standard Error 1.39
|
-0.71 beats per minute
Standard Error 1.42
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in daytime heart rate as measured by an ambulatory blood pressure monitor
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Daytime Heart Rate From Baseline to Endpoint
Baseline (Week 0)
|
75.97 beats per minute
Standard Error 2.22
|
75.37 beats per minute
Standard Error 2.26
|
|
Change in Daytime Heart Rate From Baseline to Endpoint
Change at endpoint (Week 12)
|
2.35 beats per minute
Standard Error 1.59
|
-0.87 beats per minute
Standard Error 1.62
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in nighttime (2400-0600) heart rate as measured by an ambulatory blood pressure monitor
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
Baseline (Week 0)
|
71.54 beats per minute
Standard Error 2.12
|
71.77 beats per minute
Standard Error 2.16
|
|
Change in Nighttime (2400-0600) Heart Rate From Baseline to Endpoint
Change at endpoint (Week 12)
|
1.43 beats per minute
Standard Error 1.79
|
-0.28 beats per minute
Standard Error 1.83
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in average systolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
Baseline (Week 0)
|
126.61 mmHg
Standard Error 3.04
|
119.93 mmHg
Standard Error 3.10
|
|
Change in Mean 24 Hour Systolic Blood Pressure From Baseline to Endpoint
Change at endpoint (Week 12)
|
-0.81 mmHg
Standard Error 2.67
|
-0.34 mmHg
Standard Error 2.72
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in average diastolic blood pressure measured over 24 hours by an ambulatory blood pressure monitor
Outcome measures
| Measure |
Exenatide BID
n=26 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
Baseline (Week 0)
|
75.70 mmHg
Standard Error 2.05
|
70.54 mmHg
Standard Error 2.09
|
|
Change in Mean 24 Hour Diastolic Blood Pressure From Baseline to Endpoint
Change at endpoint (Week 12)
|
-0.60 mmHg
Standard Error 1.49
|
-2.34 mmHg
Standard Error 1.52
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Intent to treat; Last observation carried forward
Change from baseline to endpoint in HbA1c
Outcome measures
| Measure |
Exenatide BID
n=27 Participants
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
n=25 Participants
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Baseline (Week 0)
|
7.50 percent
Standard Error 0.16
|
7.11 percent
Standard Error 0.17
|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Endpoint
Change at endpoint (Week 12)
|
-0.15 percent
Standard Error 0.16
|
0.12 percent
Standard Error 0.17
|
Adverse Events
Exenatide BID
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide BID
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Rib fracture
|
3.6%
1/28
|
0.00%
0/26
|
|
Psychiatric disorders
Depression
|
0.00%
0/28
|
3.8%
1/26
|
Other adverse events
| Measure |
Exenatide BID
5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
|
Placebo
Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
35.7%
10/28
|
19.2%
5/26
|
|
Nervous system disorders
Headache
|
17.9%
5/28
|
15.4%
4/26
|
|
Infections and infestations
Influenza
|
17.9%
5/28
|
26.9%
7/26
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
2/28
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.1%
2/28
|
3.8%
1/26
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28
|
7.7%
2/26
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28
|
7.7%
2/26
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28
|
19.2%
5/26
|
|
Psychiatric disorders
Depression
|
0.00%
0/28
|
7.7%
2/26
|
|
Nervous system disorders
Migraine
|
0.00%
0/28
|
7.7%
2/26
|
|
Nervous system disorders
Restlessness
|
0.00%
0/28
|
7.7%
2/26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60