E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity (N=20) vs. obesity with type 2 diabetes (N=20); Randomised + controlled + cross-over + prospective + double-blind + stratified + 2 arms: Exendin-4 vs NaCl 0.9% iv ober 100 minutes on two separate study days during event-related functional magnetic resonance imaging in hungry (fasted) and fed state (after ad libitum meal. |
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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 | 10029885 |
E.1.2 | Term | Obesity, unspecified |
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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 | 10012601 |
E.1.2 | Term | Diabetes mellitus |
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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 test the hypothesis that exendin-4 alters neuronal activity in brain areas controlling feeding behaviour in male obese without and obese subjects with diabetes mellitus type 2 compared to NaCl 0.9%.
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E.2.2 | Secondary objectives of the trial |
Effect of exendin-4 compared toNaCl 0.9% on - amount of meal intake after at least 14 hours fasting - brain activity in hunger and satiety related brain areas - subjective feeling of hunger, satiety, nausea, and well-being - plasma concentrations of insulin, C-peptide, proinsulin, leptin, PYY, ghrelin, exenatide, glukagon, free fatty acids, (LDL-) cholesterol and glukose preprandila and postprandial. Differences in brain morphology in obese and individuals with diabetes mellitus type 2 using voxel-based morphometry (T1-weighted MRI scan). |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Yes. Mophological differences in brains of lean, obese and individuals with diabetes mellitus type 2 using voxel-based morphometry. Final version. No intervention. MRI-scan. |
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E.3 | Principal inclusion criteria |
All subjects: - male - age 18-45 years - BMI ≥30 kg/m² - non vegetarians - right handedness - informed consent - normal/ corrected to normal vision - German native speaker Subjects with typ2 diabetes mellitus: - antidiabetic medicatio: metformin or sulfonylureas - duration od diabetes ≥ 2 years - HbA1c > 6.5% |
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E.4 | Principal exclusion criteria |
Subjects with T2D: - anti.diabetes drugs other than sulfonylureas or metformin
All subjects: - female - eating disorders - chronic diseases, other than T2D, hyperlipidemia or hypertension - chronic kidney failure ≥ 2 KDOQI - mental disease or retardation with impaired jugdement power - epilepsia - claustrophobia - alcohol addiction - endocrine diseases - flu-like symptoms in the previous 2 weeks - no informed consent - metallic implants/devices, e. g. pace maker - participation in another interventional trial or trial liable to insurance deductions - contraindications for study medication (e.g. hypersensitivity to ingredients- e.g. metacresol/ contraindications according SmpC/ against albumin/ plasma proteins) - non-compliance - medical therapy (especially for weight control): except antihypertensive drugs/ lipid lowering drugs |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints sensu strictu do not apply for this study.
Primary measure: - To determine hunger-associated brain activity in the CNS during exendin-4 administration in male volunteers obese without and with type 2 diabetes using BOLD-fMRI in the fasting and fed state.
Secondary measure To determine exendin-4 effect on: - the amount of food intake (calorie intake) after hunger-inducing visual stimulation in the fasting state. - changes in insulin, blood glucose, c-peptide, proinsulin, glucagon, Exenatide, HbA1c, free fatty acids and cholesterol - feelings of hunger and satiety after visual stimulation with food and non-food related images in the fasting state
Differences in brain morphology copmaring obese sunjects with ans without type 2 diabetes. |
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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 | Yes |
E.6.3 | Therapy | Yes |
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 |
Influence on regional brain activity in feeding regulation. |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | 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 | Yes |
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: For the subjects: after 2 study days wich are 7 days apart For the whole trial: last visit: december 2009, data analysis: March 2010. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |