E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
NEWLY DIAGNOSED TYPE 1 DIABETES MELLITUS |
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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 | 10045228 |
E.1.2 | Term | Type I 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 evaluate if the metformin administration, as adjunct treatment in adolescents recently diagnosed with T1DM, can preserve the residual ß-cell function preventing the c-peptide secretion failure during and overall at the end of the trial. In keeping with the DCCT conclusion that a treatment effect on c-peptide levels would have a beneficial effect on other outcomes, ADA established that an experimental treatment yielding a 50% higher mean c-peptide, or a 1.5-fold difference, would likely be considered meaningful in a clinical trial testing efficacy of preserving ß-cell function |
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E.2.2 | Secondary objectives of the trial |
To evaluate if during the trial period the metformin administration, as adjunct treatment in adolescents recently diagnosed with T1DM, can improve the blood glucose control and the glycemic stability, decrease HbA1c, the need of exogenous insulin, the number of hypoglycemic episodes, improve lipid profile, decrease the costs / benefits ratio. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. one the following 3 criteria: 1a. symptoms of diabetes (polyuria, and/or polydipsia, and/or unexplained weight loss) and a plasma glucose above 200 mg/dl at any time of day without regard to time since last meal OR 1b. fasting (no caloric intake for at least 8 hours) plasma glucose above 126 mg/dl OR 1c. 2-h plasma glucose above 200 mg/dl during an oral glucose tolerance test performed as described by the World Health Organization, using a glucose load containing glucose dissolved in water AND 2. at least one antibody to GAD65, insulin (if on insulin for less than 2 weeks), IA2 |
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E.4 | Principal exclusion criteria |
Endocrine, liver, kidney, or celiac disease, any condition that may cause a low level of oxygen in the blood or poor circulation (eg severe congestive heart failure), metabolic acidosis (except for ketoacidosis at T1DM diagnosis), sexually active females, alcohol abuse, danazol, chlorpromazine, loop diuretics, breastfeeding, pregnancy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
preserve the residual ß-cell function preventing the c-peptide secretion |
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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 | Yes |
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 | 9 |
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
|
lo studio verra' interrotto qualora non ci siano piu' i presupposti per proseguire lo studio o qualora lo sperimentatore lo ritenga opportuno sulla scorta di nuove conoscenze o sulla scorta di dati statistici parziali di non efficacia |
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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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |