E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rimonabant has been shown to reduce body weight and improve cardiovascular risk factors and metabolic control. Therefore we investigate in women with previous gestational diabetes and impaired glucose tolerance at the postpartum reclassification the impact of Rimonabant on plasma lipids, abdominal obesity, body weight and glucose tolerance (insulin sensitivity). |
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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 | 10033307 |
E.1.2 | Term | Overweight |
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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 | 10058110 |
E.1.2 | Term | Dyslipidemia |
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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 | 10051361 |
E.1.2 | Term | Adipositas |
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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 |
Aim of this study is to test the hypothesis that drug therapy with Rimonabant (20 mg/day) for 6 months in overweight women with prior gestational diabetes and impaired glucose tolerance at the postpartum reclassification will i) improve dyslipidemia, insulin sensitivity, beta cell-function and ii) reduce abdominal obesity or body weight and thus iii) convert glucose tolerance or iiii) reduce risk for progression to diabetes and iiiii) will also improve the cardiovascular risk profile compared to age and BMI matched women with prior gestational diabetes but without drug therapy. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age: 20-50 years
- Prior gestational diabetes
- BMI: BMI > 30 kg/m² OR BMI > 27 kg/m² if dyslipidemia or diabetes/pre-diabetes are present.
- Metabolism: prediabetes (IFG: fasting glucose > 100 mg/dl , but < 126 mg/dl AND/OR IGT: 2h glucose/oGTT > 140 mg/dl, but < 200 mg/dl) or diabetes (Fasting glucose > 126 mg/dl; 2h glucose/oGTT > 200 mg/dl) (WHO criteria)
- Lipids: HDL cholesterol < 50 mg/dl or triglycerides > 150 mg/dl
- Metabolic syndrome (WHO criteria)
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E.4 | Principal exclusion criteria |
- Kidney or liver disease
- Any chronic disease
- Acute or chronic inflammatory disease
- Psychiatric disorder (Depressio!)
- Lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
Plasma lipids (plasma Free Fatty Acids, triglycerides and cholesterol) OGTT: glucose tolerance, insulin and proinsulin secretion FSIGT: insulin sensitivity (SI), acute insulin response (AIRg), disposition index Adipocytokines: Visfatin, adiponectin, retinol binding protein 4, leptin, PAI-1, Ghrelin, us CRP BMI
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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 | 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) | 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 | Yes |
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 | 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.8.4.1 | 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
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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 | |