E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
sleepiness and lethargy among obese patients with diabetes |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012594 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | <Manually entered code. Term in E.1.1> |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal exclusion criteria |
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
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E.5 End points |
E.5.1 | Primary end point(s) |
Wakefulness and vigilance : Assessed by sleep latency and error analysis from the OSLER test |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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end of trial defined as attendance of patients final visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |