Primary outcomeMean· baseline and after 6 weeks of treatment
Non-REM Slow Wave Sleep
| Group | Value (minutes) | Spread |
|---|---|---|
| Usual T2 DM Med Regimen | 47.3 | 37.3 |
| Usual T2 DM Med Regimen Plus Exenatide | 34.3 | 34.4 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataImpact of Exenatide on Sleep in Type 2 Diabetes
NCTNCT01136798 (opens ClinicalTrials.gov in a new tab)Other id09-291-B
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 18 participants (actual)
- Sponsor
- University of Chicago · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 1 Jun 2010
- Primary completion
- 1 Sept 2016
- Completion
- 1 Sept 2016
- First posted
- 3 Jun 2010 (estimated)
- Last update posted
- 12 Sept 2018
- Conditions
- Type 2 Diabetes · Sleep Disordered Breathing
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2010201220142016
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators propose a pilot study to test the novel hypothesis that Exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. This project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.
Interventions
- ExenatideDrug
- PlaceboDrug
Arms2
Placebo comparator
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.
Experimental
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Non-REM Slow Wave Sleep
Time frame · baseline and after 6 weeks of treatment
Registry description
Total minutes of non-REM sleep was measured
Total Amount of Slow Wave Activity
Time frame · baseline and after 6 weeks of treatment
Registry description
Total amount of slow wave activity during sleep derived from laboratory polysomnogram was measured
Secondary outcomes(4)
Sleep Efficiency During Polysomnographic Recording
Time frame · baseline and after 6 weeks of treatment
Registry description
Sleep efficiency will be calculated as total sleep time over total recording time.
Minutes of Wake After Sleep Onset During Sleep Recording
Time frame · baseline and after 6 weeks of treatment
Registry description
total amount of time spent awake after sleep onset and before morning awakening will be calculated
Severity of Obstructive Sleep Apnea
Time frame · baseline and after 6 weeks of treatment
Registry description
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.
Mean 24-h Blood Glucose Levels
Time frame · baseline and after 6 weeks of treatment
Registry description
Mean plasma levels of glucose will be calculated from samples collected across the 24-h cycle.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcome· baseline and after 6 weeks of treatment
Total Amount of Slow Wave Activity
| Group | Value |
|---|---|
| Usual T2 DM Med Regimen | not posted |
| Usual T2 DM Med Regimen Plus Exenatide | not posted |
Secondary and other outcome results(4)
Secondary outcomeMean· baseline and after 6 weeks of treatment
Sleep Efficiency During Polysomnographic Recording
| Group | Value (percentage of total recording time) | Spread |
|---|---|---|
| Usual T2 DM Med Regimen | 84.3 | 6.8 |
| Usual T2 DM Med Regimen Plus Exenatide | 85.3 | 6.1 |
Secondary outcomeMean· baseline and after 6 weeks of treatment
Minutes of Wake After Sleep Onset During Sleep Recording
| Group | Value (minutes) | Spread |
|---|---|---|
| Usual T2 DM Med Regimen | 70.4 | 33.1 |
| Usual T2 DM Med Regimen Plus Exenatide | 56.6 | 23 |
Secondary outcomeMean· baseline and after 6 weeks of treatment
Severity of Obstructive Sleep Apnea
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Usual T2 DM Med Regimen | 15.9 | 9.6 |
| Usual T2 DM Med Regimen Plus Exenatide | 16.4 | 10.9 |
Secondary outcomeMean· baseline and after 6 weeks of treatment
Mean 24-h Blood Glucose Levels
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Usual T2 DM Med Regimen | 134.4 | 18.1 |
| Usual T2 DM Med Regimen Plus Exenatide | 142.2 | 37.5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Usual T2 DM Med RegimenSubjects 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 | – | 0 / 10 | 0 / 10 |
| Usual T2 DM Med Regimen Plus ExenatideSubjects 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 | – | 0 / 8 | 0 / 8 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Patients with a diagnosis of T2DM based on physician documentation according to established guidelines will be eligible.
Exclusion Criteria:
* Patients with unstable cardiac, neurological or psychiatric disease
* Women who are pregnant or report trying to get pregnant will be excluded.
* Patients treated for obstructive sleep apnea (OSA) will be excluded.
* Patients with established OSA will be included only if they have declined treatment of OSA.
* Patients with morbid obesity (BMI ≥ 40 gk/m2)
* Patients on insulin
* Patients already taking an incretin-based drug will not be included
* Patients with renal disease (creatinine clearance \<30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects.
* Patients taking an insulin secretagogue will be excluded.
* Patients with Hemoglobin A1c values greater than or equal to 10 will be excluded.
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