Effects of Exenatide on excess daytime sleepiness (EDS), wakefulness and driving performance in obese type-2 diabetes patients without sleep apnea – proof of concept study - exenatide on daytime sleepiness
- Conditions
- sleepiness and lethargy among obese patients with diabetesMedDRA version: 1Level: LLTClassification code 10012594Term: <Manually entered code. Term in E.1.1>MedDRA version: 1Level: LLTClassification code 10029883Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-008141-37-GB
- Lead Sponsor
- Sherwood Forest Hospitals Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
•Type 2 diabetes, on a stable medication regimen
•Excess daytime sleepiness (Epworth score >9)
•HbA1c 7.5-12.0%.
•Age 18-65 years
•BMI 28-40
•Subjects would have undergone a sleep study in the sleep laboratory at the Sherwood Forest Hospitals Foundation Trust and sleep apnoea has been excluded.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
•Patients with congestive heart failure, depression, cancer, central nervous system demyelinating disorders, recurrent or active infection.
•HbA1c <7.5% or >12%)
•Age <18 or >65 years
•BMI <28 or >40
•Patients who could not tolerate exenatide therapy
•Presence of obstructive sleep apnoea
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method