Trial Outcomes & Findings for Impact of Exenatide on Sleep in Type 2 Diabetes (NCT NCT01136798)
NCT ID: NCT01136798
Last Updated: 2018-09-12
Results Overview
Total minutes of non-REM sleep was measured
COMPLETED
NA
18 participants
baseline and after 6 weeks of treatment
2018-09-12
Participant Flow
Participant milestones
| Measure |
Usual T2 DM Med Regimen
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Exenatide on Sleep in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Usual T2 DM Med Regimen
n=10 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=8 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and after 6 weeks of treatmentPopulation: The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.
Total minutes of non-REM sleep was measured
Outcome measures
| Measure |
Usual T2 DM Med Regimen
n=9 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=7 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Non-REM Slow Wave Sleep
Baseline
|
47.3 minutes
Standard Deviation 37.3
|
34.3 minutes
Standard Deviation 34.4
|
|
Non-REM Slow Wave Sleep
At 6 week
|
57.3 minutes
Standard Deviation 38.1
|
41.4 minutes
Standard Deviation 40.3
|
PRIMARY outcome
Timeframe: baseline and after 6 weeks of treatmentPopulation: The second primary outcome measure, slow-wave activity (SWA) was not collected.
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and after 6 weeks of treatmentPopulation: The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.
Sleep efficiency will be calculated as total sleep time over total recording time.
Outcome measures
| Measure |
Usual T2 DM Med Regimen
n=9 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=7 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Sleep Efficiency During Polysomnographic Recording
Baseline
|
84.3 percentage of total recording time
Standard Deviation 6.8
|
85.3 percentage of total recording time
Standard Deviation 6.1
|
|
Sleep Efficiency During Polysomnographic Recording
At 6 week
|
83.8 percentage of total recording time
Standard Deviation 9.2
|
89.4 percentage of total recording time
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: baseline and after 6 weeks of treatmentPopulation: The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.
total amount of time spent awake after sleep onset and before morning awakening will be calculated
Outcome measures
| Measure |
Usual T2 DM Med Regimen
n=9 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=7 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Minutes of Wake After Sleep Onset During Sleep Recording
Baseline
|
70.4 minutes
Standard Deviation 33.1
|
56.6 minutes
Standard Deviation 23
|
|
Minutes of Wake After Sleep Onset During Sleep Recording
At 6 week
|
52.3 minutes
Standard Deviation 26.7
|
36.6 minutes
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: baseline and after 6 weeks of treatmentPopulation: The Electronic Sleep Recordings for one participant in Usual T2 DM med regimen were corrupted and could not be analyzed. One participant in Usual T2 DM med regimen plus Exenatide had a very short sleep periods during the study and his data could not be interpreted, therefore this patient was excluded from the analysis.
The apnea-hypopnea index (AHI) will be calculated from polysomnographic recordings. The minimum score for AHI is 0 (zero), corresponding to total absence of apnea or hypopnea. There is no theoretical maximum score although scores above 100 are very rarely observed. The lower the AHI value, the better. Higher AHI values correspond to greater severity of sleep apnea, a worse outcome. There are no subscales. We use continuous AHI values to measure severity of obstructive sleep apnea.
Outcome measures
| Measure |
Usual T2 DM Med Regimen
n=9 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=7 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Severity of Obstructive Sleep Apnea
Baseline
|
15.9 units on a scale
Standard Deviation 9.6
|
16.4 units on a scale
Standard Deviation 10.9
|
|
Severity of Obstructive Sleep Apnea
At 6 week
|
16.5 units on a scale
Standard Deviation 11.4
|
10.9 units on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: baseline and after 6 weeks of treatmentMean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
Outcome measures
| Measure |
Usual T2 DM Med Regimen
n=10 Participants
Subjects will continue on Type 2 DM therapy but will add placebo injected subcutaneously twice daily to their regimen for a total of 6 weeks.
Placebo: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
Usual T2 DM Med Regimen Plus Exenatide
n=8 Participants
Subjects will continue on Type 2 DM therapy but will add injectable exenatide to their regimen There will be twice daily treatment with subcutaneous injections of 5 µg of Exenatide for 2 weeks followed by 4 weeks of treatment with twice daily subcutaneous injections of 10 µg of Exenatide.
Exenatide: Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
|
|---|---|---|
|
Mean 24-h Blood Glucose Levels
Baseline
|
134.4 mg/dl
Standard Deviation 18.1
|
142.2 mg/dl
Standard Deviation 37.5
|
|
Mean 24-h Blood Glucose Levels
At 6 week
|
141.3 mg/dl
Standard Deviation 22.1
|
136.1 mg/dl
Standard Deviation 39.2
|
Adverse Events
Usual T2 DM Med Regimen
Usual T2 DM Med Regimen Plus Exenatide
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