E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes tipo 2
Type 2 diabetes |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 |
El objetivo principal es investigar la seguridad y la tolerabilidad a largo plazo de SIBA. Esto se realiza comparando SIBA con insulina glargina después de 104 semanas de tratamiento (52 semanas de tratamiento en ensayo NN1250 3579 más 52 semanas de tratamiento en este estudio de extensión) en lo que se refiere a las evaluaciones de seguridad indicadas, a partir de las cuales se calcularán criterios de valoración: - Acontecimientos adversos - Episodios de hipoglucemia - Evaluaciones clínicas - Evaluaciones de laboratorio - Peso corporal - Dosis de insulina The primary objective is to investigate the long-term safety and tolerability of NN1250. This is done by comparing NN1250 to insulin glargine after 104 weeks of treatment (52 weeks of treatment in NN1250-3579 plus 52 weeks of treatment in this extension trial) in terms of the listed safety assessments from which endpoints will be calculated: Adverse events, Hypoglycaemic episodes, Clinical evaluation, Laboratory assesments,.. |
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E.2.2 | Secondary objectives of the trial |
El objetivo secundario es comparar la eficacia entre SIBA e insulina glargina después de 104 semanas de tratamiento en cuanto a las evaluaciones de eficacia indicadas, a partir de las cuales se calcularán criterios de valoración: - HbA1c (laboratorio central) - Glucemia plasmática en ayunas (GPA) medida en un laboratorio central - Perfiles de automedición de la glucemia plasmática (AMGP) de 9 puntos - Glucemia medida por el paciente para realizar ajustes de la dosis
The secondary objective is to compare the efficacy between NN1250 and insulin glargine after 104 weeks of treatment, in terms of the listed efficacy assessments from which endpoints will be calculated: - HbA1c (central laboratory) - Fasting plasma glucose (FPG) measured at a central laboratory - 9-point self measured plasma glucose (SMPG) profile - Self measured plasma glucose for dose adjustments |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Obtención del consentimiento informado antes de realizar ninguna actividad relacionada con el estudio de extensión. (Son actividades relacionadas con el estudio de extensión todos los procedimientos que no se habrían realizado durante la asistencia normal al paciente o como parte del ensayo principal NN1250 3579.) 2.El paciente deberá haber completado el período de tratamiento de 52 semanas del ensayo NN1250 3579.
1. Informed consent obtained before any trial-related activities. (Extension trial-related activities are defined as any procedure that would not have been performed during normal management of the subject or as part of the main trial NN1250-3579.) 2. The subject must have completed the 52 week treatment period in trial NN1250-3579. |
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E.4 | Principal exclusion criteria |
1.Participación previa en este ensayo. La participación se define como participación en cualquiera de los procedimientos relacionados con la visita 43. 2.Las mujeres en edad fértil no podrán participar si estén embarazadas o dando el pecho o si tienen intención de quedarse embarazadas, si no utilizan métodos anticonceptivos adecuados (las medidas anticonceptivas adecuadas exigidas por la legislación o la práctica local [para Alemania: implantes, inyectables, anticonceptivos orales combinados, DIU hormonal, abstinencia sexual o pareja con vasectomía]). 3.Modificación prevista de medicamentos concomitantes que se sabe interfieren significativamente en el metabolismo de la glucosa, como corticosteroides sistémicos, betabloqueantes o inhibidores de la MAO.
1. Previous participation in this trial. Participation is defined as participation in any Visit 43 related procedures. 2. Females of childbearing potential who are pregnant, breast-feeding, or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practise [for Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner]. 3. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Número de acontecimientos adversos de aparición durante el tratamiento con inicio el primer día de exposición al fármaco del ensayo aleatorizado o después, pero no más tarde de 7 días después de la última exposición al fármaco del ensayo aleatorizado - Número de episodios de hipoglucemia severos o menores de aparición durante el tratamiento con inicio el primer día de exposición al fármaco del ensayo aleatorizado o después, pero no más tarde de 7 días después de la última exposición al fármaco del ensayo aleatorizado - Variación de los anticuerpos contra la insulina con respecto al estado basal tras 104 semanas de tratamiento
- Number of treatment emergent adverse events with an onset on or after the first day of exposure to randomised trial drug and no later than 7 days after last exposure to randomised trial drug - Number of severe and minor treatment emergent hypoglycaemic episodes with an onset on or after the first day of exposure to randomised trial drug and not later than 7 days after last exposure to randomised trial drug - Change from baseline in insulin antibodies after 104 weeks of treatment |
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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) | 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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 73 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 1 |
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 | 1 |
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 |