sleepiness and lethargy among obese patients with diabetes MedDRA version: 1 Level: LLT Classification code 10012594 Term: MedDRA version: 1 Level: LLT Classification code 10029883 Term:
Conditions
Interventions
Trade Name: Byetta
Product Name: exenatide
Pharmaceutical Form: Solution for injection
INN or Proposed INN: exenatide
CAS Number: 141732-76-5
Current Sponsor code: AC2993, LY2148568
Other descripti
Sponsors
Sherwood Forest Hospitals Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: Exclusion Criteria • Patients with congestive heart failure, depression, cancer, central nervous system demyelinating disorders, recurrent or active infection. • HbA1c 12%) • Age 65 years • BMI 40 • Patients who could not tolerate exenatide therapy • Presence of obstructive sleep apnoea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the administration of Exenatide (10mcg BD by subcutaneous injection) in obese patients with type 2 diabetes without sleep apnoea (excluded by in-patient multi channel sleep study) but with symptoms of excess daytime sleepiness and suboptimal glycaemic control (hAb1c >7.5%), would result in a significant improvement in objective measure of daytime sleepiness and wakefulness (as determined by the sustained attention test (OsLer test). This will be a proof concept study where patients undergo a fixed-order design allocation of placebo for 10 weeks followed by exenatide for 10 weeks.;Secondary Objective: To investigate whether ten weeks administration of Exenatide (10mcg BD by subcutaneous injection) in obese patients with type 2 diabetes without sleep apnoea would result in a significant improvement in driving performance (assessed using a driving simulator), levels of ‘somnogenic cytokines’ (e.g. interleukin-6, TNF-alpha), Hba1c, weight and waist circumference;Primary end point(s): Wakefulness and vigilance : Assessed by sleep latency and error analysis from the OSLER test | — |
Countries
United Kingdom
Outcome results
None listed