E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10027433 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10003018 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10018067 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029883 |
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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 assess whether changes in BMI and one or more additional cardiovascular risk factors (waist circumferance, HOMA-IR, HDL cholesterol, triglycerides, arterial blood pressure) occur during and/or after metformin treatment in insulin-resistant obese patients aged 10 to 16 years. |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether changes in cytokine levels during and/or after metformin therapy occur in insulin-resistant obese patients aged 10 to 16 years. This will clarify the role of cytokines in the obesity-related insulin resistance. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Caucasian subjects of both sexes, between 10 and 16 years of age. Inclusion Criteria: 1) BMI higher or equal to 95� percentile for sex and age; 2) HOMA-IR higher or equal to 2,5 in pre-pubertal patients and 4 in pubertal patients 3) HDL cholesterol inferior or equal to 40 mg/dl, or triglycerides higher or equal to 150 mg/dl, or systolic pressure higher or equal to 130 mmHg, or diastolic pressure higher or equal to 85 mmHg. |
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E.4 | Principal exclusion criteria |
Exclusion Criteria : 1) Type 1 or 2 Diabetes Mellitus 2) Contraindications to the use of metformin (renal disease or dysfunction, congestive heart failure requiring pharmacologic treatment, known hypersensitivity to metformin, acute or chronic metabolic acidosis) 3) Endocrine, liver diseases 4) Ongoing therapies for chronic systemic diseases 5) Patients at risk of pregnancy or lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using a contraception method. 6) Lactose intolerance |
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E.5 End points |
E.5.1 | Primary end point(s) |
Variation of BMI and of prevalence of one or more additional cardiovascular risk factors (waist circumference, HOMA-IR, glucose, HDL cholesterol, triglycerides, arterial blood pressure) during and/or after metformin. |
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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 | No |
E.6.4 | Safety | Yes |
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) | Yes |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |