E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes Diabetes Tipo 2 |
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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 NN1250 en combinación con insulina aspart. Esto se realiza comparando NN1250 + insulina aspart ± ADO(s) con insulina glargina + insulina aspart ± ADO(s) después de 78 semanas de tratamiento (52 semanas de tratamiento en NN1250-3582 más 26 semanas de tratamiento en este ensayo 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 del laboratorio central peso corporal dosis de insulina |
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E.2.2 | Secondary objectives of the trial |
El objetivo secundario es comparar la eficacia entre NN1250 e insulina glargina, ambas en combinación con insulina aspart ± metformina ± pioglitazona, después de 78 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 Perfiles de automedición de la glucemia plasmática (AMGP) de 4 puntos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent obtained before any extension 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 trial NN1250-3582). 2. The subject must have completed the 52-week treatment period (Visit 41 in trial NN1250-3582). 1.Obtención del consentimiento informado antes de realizar ninguna actividad relacionada con el ensayo de extensión. (Son actividades relacionadas con el ensayo de extensión todos los procedimientos que no se habrían realizado durante la asistencia normal al paciente o como parte del ensayo NN1250-3582.) 2.El paciente deberá haber completado el período de tratamiento de 52 semanas (visita 41 del ensayo NN1250-3582). |
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E.4 | Principal exclusion criteria |
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 (for Germany: implants, injectables, combined oral contraceptives, hormonal intrauterine device (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. 4. For pioglitazone user: clinically significant peripheral oedema or contraindications/restrictions to pioglitazone use. 1.Participación previa en este ensayo. La participación se define como participación en cualquiera de los procedimientos relacionados con la visita 43. 2.Mujeres en edad fértil que estén embarazadas o dando el pecho o si tienen intención de quedarse embarazadas, si no utilizan métodos anticonceptivos adecuados (para Alemania: implantes, inyectables, anticonceptivos orales combinados, dispositivo intrauterino (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. 4.Para pacientes que reciban pioglitazona: edema periférico clínicamente significativo o contraindicaciones/limitaciones para el uso de pioglitazona. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- 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. 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 graves 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 |
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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 | 60 |
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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Not applicable No aplicable |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |