E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 1 |
Diabetes Mellitus tipo 1 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 1 diabetes |
Diabetes Mellitus tipo 1 |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
|
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 confirm the efficacy of insulin degludec/insulin aspart administered once daily plus meal-time insulin aspart for the remaining meals in controlling glycaemia with respect to change from baseline in HbA1c after 16 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c between insulin degludec/insulin aspart + meal-time insulin aspart for the remaining meals and insulin detemir + meal-time insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%. |
Confirmar la eficacia de insulina degludec/insulina aspart administrada una vez al día más insulina aspart prandial con el resto de las comidas para controlar la glucemia según la variación de HbA1c con respecto al valor basal después de 16 semanas de tratamiento. Para ello se comparará la diferencia en la variación de HbA1c con respecto al valor basal entre insulina degludec/insulina aspart + insulina aspart prandial con el resto de las comidas e insulina detemir + insulina apart aspart prandial con un límite de no inferioridad del 0,4%, y si se confirma la no inferioridad, con un límite de superioridad del 0%. |
|
E.2.2 | Secondary objectives of the trial |
To compare the efficacy and safety between the two treatment groups after 16 weeks of treatment |
Comparar la eficacia y la seguridad entre los dos grupos de tratamiento después de 16 semanas de tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2) Subjects diagnosed with type 1 diabetes mellitus 3) Age: 1 to <18 years of age at randomisation 4) HbA1c ? 11.0% |
1)Obtención del consentimiento informado antes de realizar cualquiera de las actividades relacionadas con el ensayo. Se consideran actividades relacionadas con el ensayo todos los procedimientos que se lleven a cabo como parte del ensayo, incluidas las actividades para determinar la idoneidad para el ensayo. 2)Sujetos con diagnóstico de diabetes mellitus de tipo 1. 3)Edad: De 1 a <18 años en el momento de la aleatorización. 4)HbA1c ?11,0% |
|
E.4 | Principal exclusion criteria |
1) Known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator 2) More than 1 episode of diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to Visit 1 (Screening) 3) Any chronic disorder or significant concomitant disease, which in the investigator?s opinion might jeopardise the subject?s safety or compliance with the protocol |
1)Falta de percepción de hipoglucemia conocida o episodios recurrentes de hipoglucemia grave según el criterio del investigador. 2)Más de 1 episodio de cetoacidosis diabética que precise haya precisado hospitalización en los 3 meses previos a la visita 1 (selección). 3)Cualquier trastorno crónico o enfermedad concomitante importante que, en opinión del investigador, pueda poner en peligro la seguridad del sujeto o el cumplimiento del protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c (%) |
Variación de HbA1c con respecto al valor basal (%) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After 16 weeks of treatment |
Tras 16 semanas de tratamiento |
|
E.5.2 | Secondary end point(s) |
- Change from baseline in fasting plasma glucose - Incidence of treatment emergent adverse events (TEAEs) - Hypoglycaemia: - Number of treatment emergent confirmed hypoglycaemic episodes (PG<3.1 mmol/L (56 mg/dL) or severe hypoglycaemia ) - Number of treatment emergent nocturnal confirmed hypoglycaemic episodes - Hyperglycaemia: - Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill - Number of hyperglycaemic episodes (PG > 14.0 mmol/L (250 mg/dL) where subject looks/feels ill with ketosis (blood ketones > 1.5 mmol/L) |
?Variación con respecto al valor basal de la glucosa plasmática en ayunas. ?Incidencia de acontecimientos adversos aparecidos con el tratamiento (AAAT). ?Hipoglucemia: -Número de episodios confirmados de hipoglucemia aparecidos con el tratamiento (GP <3,1 mmol/l (56 mg/dl) o hipoglucemia grave). -Número de episodios nocturnos confirmados de hipoglucemia aparecidos con el tratamiento. ?Hiperglucemia: -Número de episodios de hiperglucemia (GP >14,0 mmol/l (250 mg/dl) en los que el sujeto parece o se siente enfermo. -Número de episodios de hiperglucemia (GP >14,0 mmol/l (250 mg/dl) en los que el sujeto parece o se siente enfermo con cetosis (cetonas sanguíneas >1,5 mmol/l). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
After 16 weeks of treatment |
Tras 16 semanas de tratamiento |
|
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Con ajuste de dosis |
Treat-to-target |
|
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | No |
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 |
European Union |
Brazil |
Canada |
India |
Israel |
Macedonia, the former Yugoslav Republic of |
Russian Federation |
Serbia |
South Africa |
United States |
Croatia |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |