E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 2 |
Diabetes Mellitus tipo 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Diabetes tipo 2 |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II 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 compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin Neutral Protamine Hagedorn (NPH) in combination with metformin and diet/exercise in controlling glycaemia, after 26 weeks of treatment, in children and adolescents (aged 10?17 years) with type 2 diabetes, who are insufficiently treated with metformin ± other OAD(s) ± basal insulin. |
Comparar la eficacia de la insulina detemir en combinación con metformina y dieta/ejercicio frente a la insulina protamina neutra de Hagedorn (NPH) en combinación con metformina y dieta/ejercicio en el control glucémico, después de 26 semanas de tratamiento, en niños y adolescentes (con edades comprendidas entre los 10 y 17 años) con diabetes de tipo 2, que reciben un tratamiento insuficiente con metformina ±otros ADO ± insulina basal. |
|
E.2.2 | Secondary objectives of the trial |
In children and adolescents (aged 10?17 years) with type 2 diabetes, who are insufficiently treated with metformin ± other OAD(s) ± basal insulin: 1. To compare the efficacy of insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin and diet/exercise on body weight, after 26 weeks of treatment 2. To compare the proportion of subjects achieving glycaemic control without experiencing severe hypoglycaemia, after 26 weeks of treatment, for insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin) and diet/exercise. 3. To assess and compare the safety and tolerability of insulin detemir in combination with metformin and diet/exercise versus insulin NPH in combination with metformin and diet/exercise, during 26 weeks of treatment. |
en niños y adolescentes (con edades comprendidas entre los 10 y 17 años) con diabetes de tipo 2, que reciben un tratamiento insuficiente con metformina ±otros ADO ± insulina basal: 1.Comparar la eficacia de la insulina detemir en combinación con metformina y dieta/ejercicio frente a la insulina NPH en combinación con metformina y dieta/ejercicio en el peso corporal, después de 26 semanas de tratamiento, 2.Comparar el porcentaje de pacientes que logran un control glucémico sin experimentar hipoglucemia grave, después de 26 semanas de tratamiento, con insulina detemir en combinación con metformina y dieta/ejercicio frente a insulina NPH en combinación con metformina y dieta/ejercicio, 3.Evaluar y comparar la seguridad y la tolerabilidad de la insulina detemir en combinación con metformina y dieta/ejercicio frente a la insulina NPH en combinación con metformina y dieta/ejercicio, durante 26 semanas de tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent from the subject or a legally acceptable representative (LAR) and child assent from the subject 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. Male or female, 10 years ? age ?17 years at the time of signing informed consent/assent 3. Diagnosis of type 2 diabetes mellitus at least 3 months prior to screening 4. Treated with a stable dose of metformin (1000-2000 mg/day) for at least 3 months prior to screening ± other OAD(s) ± basal insulin 5. HbA1c; ? 7.0% and ? 10.5% (? 53 mmol/mol and ? 91 mmol/mol) at screening |
1.Consentimiento informado del paciente o su representante legal (RL) y asentimiento del niño obtenidos antes de realizar cualquier actividad relacionada con el ensayo. Se consideran actividades relacionadas con el ensayo todos los procedimientos realizados como parte del mismo, incluidas las actividades realizadas para determinar si se cumplen los requisitos de participación. 2.Hombres y mujeres, con una edad comprendida entre los 10 y 17 años, ambos inclusive, en el momento de firmar el consentimiento informado/asentimiento. 3.Diagnóstico de diabetes mellitus de tipo 2 durante al menos 3 meses antes de la selección. 4.Tratamiento estable de metformina (1000-2000 mg/día) sola o en combinación con otros ADO o insulina basal durante al menos 3 meses antes de la selección. 5.HbA1c; ? 7,0 % y ? 10,5 % (? 53 mmol/mol y ? 91 mmol/mol) en la selección. |
|
E.4 | Principal exclusion criteria |
1. Maturity onset diabetes of the young (MODY) 2. Fasting C-peptide at screening <0.6 ng/mL 3. Impaired liver function defined as alanine aminotransferase (ALT) ? 2.5 times upper normal limit 4. Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator |
1.Diabetes juvenil de comienzo en la madurez (MODY). 2.Péptido C en ayunas <0,6 ng/ml en la selección. 3.Disfunción hepática, definida como un valor de alanina aminotransferasa (ALT) ? 2,5 veces el límite superior de la normalidad. 4.Retinopatía proliferativa o maculopatía conocidas con necesidad de tratamiento agudo según el criterio del investigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Variación en la HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to Week 26 |
Entre el momento basal y la semana 26 |
|
E.5.2 | Secondary end point(s) |
1. Change in body weight standard deviation score (SDS) 2. Proportion of subjects achieving HbA1c <7.0%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment 3. Proportion of subjects achieving HbA1c <7.5%, who have not experienced any treatment emergent severe hypoglycaemic episodes within the last 14 weeks of treatment 4. Total number of treatment emergent nocturnal (23:00-06:59) severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes 5. Total number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes 6. Incidence of adverse events (AEs) |
1.Variación de la PDE del peso corporal entre el momento basal y la semana 26 2.Porcentaje de pacientes que alcanzaron una HbA1c <7,0 % , que no experimentaron episodios de hipoglucemia grave surgidos a consecuencia del tratamiento en las últimas 14 semanas de tratamiento. 3.Porcentaje de pacientes que alcancen una HbA1c <7,5 % , que no experimentaron episodios de hipoglucemia grave surgidos a consecuencia del tratamiento en las últimas 14 semanas de tratamiento.* 4.Número total de episodios de hipoglucemia sintomática nocturna (23:00-6:59) grave o confirmada mediante determinación de la glucemia surgidos con el tratamiento |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. From baseline to Week 26 2. - 3. At Week 26 4. - 6. During 26 weeks of treatment |
1.Entre el momento basal y la semana 26 2. - 3. En la semana 26 3. - 6. Durante 26 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability |
Tolerabilidad |
|
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
Argentina |
Australia |
Brazil |
Canada |
China |
European Union |
India |
Israel |
Japan |
Macedonia, the former Yugoslav Republic of |
Malaysia |
Mexico |
Russian Federation |
Serbia |
South Africa |
Taiwan |
Turkey |
United States |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |