E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
no diabetic, obese subjects with BMI≥40 kg.m-2 |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029883 |
E.1.2 | Term | Obesity |
|
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 test the hypothesis that exenatide influences, in obese subjects, hepatic glucose retention in physiologic post-prandial conditions |
|
E.2.2 | Secondary objectives of the trial |
To value the effect of 3 months of treatment with exenatide vs no treatment(control group) on: 1. ß-cell function and glucose sensibility of ß-cell 2. insuline sensibility 3. hormones (insuline, glucagone, C-peptide, GIP, GLP-1, ghrelin) 4. lipidic profile 5. standard biochemical parameters 6. pro-inflammatory markers 7. weight |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(a) both sexes; (b) age between 30 and 60; (c) BMI ≥ 40 kg.m-2; (d) plasmatic glucose on fasting < 7 mmol/l (126mg/dl) and plasmatic glucose after 2 hours from bolus during OGTT < 11.1 mmo/l (200 mg/dl) without antidiabetic treatment. |
|
E.4 | Principal exclusion criteria |
(a) diabetes type 2; (b) pregnancy, breast feeding and women in fertil age who don't use any contraceptive method , or who present positive test pregnancy; (c) psychiatric troubles; (d) troubles of alimentary behaviour (nervous anorexia or nervous bulimia ); (e) blindness, (f) serious clinic conditions(hepatic cirrhosis , renal insufficiency (creatinine > 2.0 mg/dl), malignant neoplasia , cardiac insufficiency, recent stroke, angina pectoris (g) treatment with pharmacological agents that influence carbohydrate homeostasis or antidepressant drugs (h) disorder of the gastrointestinal motility, (i) partecipation in other clinic study or in four weeks previous the recruitment. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
valutation of hepatic glucose retention |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
valutazione meccanismo ed effetti metabolici in pazienti obesi |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
|
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |