E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Obesity Diabetes Mellitus Metabolic syndrome |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 examine the effects of short term Topiramate treatment in obese women on: -Endogenous glucose production (EGP) liver -Whole body glucose disposal -Whole body lipid disposal -Whole body glucose and lipid oxidation rates -Blood cholesterol level -Total energy expenditure -Beta cell sensitivity
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Female volunteers -Age > 18 years and < 70 years -BMI > 27 kg/m2 and < 44 kg/m2 -Fasting serum glucose (FSG) > 6.1 and < 7.0 mmol/L
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E.4 | Principal exclusion criteria |
-FSG >6 mmol/L -Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past. -Any significant chronic disease -Any significant abnormal laboratory results found during the medical screening procedure -Renal, hepatic or endocrine disease (including DM) -Use of medication known to influence lipolysis and/or glucose metabolism -Premenopausale women who do not use oral contraceptives or intrauterine device -Recent weight changes of attempts to loose weight (> 3 kg weight gain or loss, within the last 3 months) -Difficulties to insert an intravenous catheter -Smoking -Severe claustrophobia (ventilated hood) -Recent blood donation (within the last 3 months) -Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in all of the following study endpoints after placebo or topiramate -Endogenous glucose production determined by [6,6-2H2] glucose infusion and a two-step hyperinsulinaemic euglycaemic clamp. -Whole body glucose disposal determined by [6,6-2H2] glucose infusion and a two-step hyperinsulinaemic euglycaemic clamp. -Whole body lipolysis as determined by Ra of glycerol (measured by [2H5]-glycerol infusion), and lipid oxidation as determined by indirect calorimetry. -Blood Cholesterol levels (LDL-C, HDL-C, TG, TC) -Total energy expenditure (measured by actimeter) -Beta cell sensitivity
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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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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 | 0 |