E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes tipo 1 recien diagnosticada |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10012602 |
E.1.2 | Term | Diabetes mellitus (incl subtypes) |
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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 |
Evaluar la factibilidad, seguridad/tolerancia y potencial eficacia de la terapia con anti-IL-1 en el mantenimiento o mejora de la función de células beta en personas con diabetes mellitus tipo 1 de reciente diagnóstico |
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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 |
Diagnóstico de Diabetes tipo 1 según criterios OMS 1999 Edad entre 18-35 años a diagnóstico Autoanticuerpos IA-2 y/o GAD positivo Menos de 12 semanas desde los primeros síntomas de la diabetes Pico de Péptido C ≥ 200pM en un test realizado tras la ingesta de una comida estándar y con el sujeto metabólicamente estable (tras resolución de cualquier posible poliuria, polidipsia o cetoacidosis) |
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E.4 | Principal exclusion criteria |
Enfermedad renal o hepática severa (creatinina >100µmol/L, AST/LT > 2*ULN, fosfatasa alcalina > 2*ULN) Antecedentes de enfermedad cardíaca, síntomas de fallo cardíaco o ECG anormal Enfermedad maligna previa o actual Mujeres embrazadas o lactantes Participación en otros ensayos clínicos con medicamentos Terapia antiinflamatoria (excepto aspirina < 100mg/d) Infecciones activas, antecedentes de infecciones recurrentes o predisposición a infecciones Neutropenia: ANC < 1.5 *109/L, o anemia: Hemoglobina < 8.0 g/dL Inmunodeficiencia o tratamiento inmunosupresor Evidencia de complicaciones diabéticas significativas Vacunación con vacunas vivas Uso de Etarnecept en las 4 semanas previas al screening o durante el período de doble ciego del estudio Hipersensibilidad a proteínas derivadas de E. coli, anakinra o cualquier componente del producto |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incremento del área bajo la curva de 2h de péptido C entre la visita basal y a los 9 meses
Los criterios de valoración secundarios incluyen: -Incremento del incremento y/o pico de respuesta del péptido C -Incremento del tiempo del pico de péptido C -Incremento de los requerimientos de insulina diarios por Kg de peso -Incremento en la frecuencia de independencia de la insulina manteniendo una HbA1c<7,5% -Incrementos en HbA1c y glucosa plasmática en ayunas, aunque los investigadores intentarán optimizar al máximo la glucemia en ambas ramas del tratamiento. -Incrementos en la medias de las glucemias plasmáticas en ayunas -Incrementos en los niveles de proteína C reactiva e IL-6 circulantes |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |