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 | 14.1 |
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 | 10027433 - Metabolism and nutrition disorders |
|
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 superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10?17 years) with type 2 diabetes. |
Confirmar la superioridad de la liraglutida en la dosis máxima tolerada (0,6 mg, 1,2 mg, 1,8 mg) en combinación con metformina para controlar la glucemia en comparación con metformina y placebo de liraglutida en niños y adolescentes (edad 10?17 años) con diabetes de tipo 2. |
|
E.2.2 | Secondary objectives of the trial |
To assess and compare the effect of liraglutide in combination with metformin versus metformin alone on: - Parameters of glycaemic control - Safety and tolerability |
Evaluar y comparar el efecto de la liraglutida en combinación con metformina en comparación con metformina sola en: ?Parámetros de control de la glucemia ?Seguridad y tolerabilidad |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Children and adolescents between the ages of 10?17 years. Subjects cannot turn 18 before completion of the 14 week double blind period (Visit 11) - Diagnosis of type 2 diabetes mellitus and treated for at least 90 days with diet and exercise alone, or diet and exercise in combination with metformin monotherapy. The metformin dose must be stable for at least 30 days prior to screening (Visit 1). - HbA1c - ?7.0% and ?11% if diet and exercise treated - ?6.5% and ?11% if treated with metformin - Body mass index (BMI) >85% percentile of the general age and gender matched population |
? Niños y adolescentes de 10 a 17 años de edad. Los sujetos no pueden cumplir 18 años antes de que finalice el período doble ciego de 14 semanas (visita 11). ? Diagnóstico de diabetes mellitus de tipo 2 y tratamiento durante al menos 90 días con dieta y ejercicio únicamente, o dieta y ejercicio en combinación con metformina en monoterapia. La dosis de metformina debe haberse mantenido estable durante al menos 30 días antes de la visita de selección (visita 1). ? HbA1c ? Mayor o igual a 7,0 % y menor o igual a 11 % si el tratamiento consiste en dieta y ejercicio. ? Mayor o igual a 6,5 % y menor o igual a 11 % si el sujeto está recibiendo metformina. ? Índice de masa corporal (IMC) superior al percentil 85 de la población general de la misma edad y sexo. |
|
E.4 | Principal exclusion criteria |
- Type 1 diabetes - Maturity onset diabetes of the young (MODY) - Use of any antidiabetic agent other than metformin within 90 days prior to screening. Short term treatment with insulin is allowed - Recurrent severe or major hypoglycaemia or hypoglycaemic unawareness as judged by the investigator - History of chronic pancreatitis or idiopathic acute pancreatitis - Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator?s opinion could interfere with results of the trial - Uncontrolled hypertension, treated or untreated >99th percentile for age and gender in children - Known or suspected abuse of alcohol or narcotics |
? Diabetes de tipo 1. ? Diabetes juvenil de comienzo en la madurez (MODY). ? Utilización de antidiabéticos distintos de metformina en los 90 días previos a la visita de selección. Se permite el tratamiento a corto plazo con insulina. ? Hipoglucemia intensa o importante recurrente o falta de conciencia de la hipoglucemia según el criterio del investigador. ? Antecedentes de pancreatitis crónica o pancreatitis aguda idiopática. ? Cualquier trastorno con importancia clínica, salvo los procesos asociados a los antecedentes de diabetes de tipo 2 que, en opinión del investigador, pudiera interferir en los resultados del ensayo. ? Hipertensión no controlada, tratado o no tratada, por encima del percentil 99 para la edad y el sexo en niños. ? Abuso confirmado o sospechado de alcohol o narcóticos. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Cambio en HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From baseline to week 14 |
Desde el momento basal hasta la semana 14 |
|
E.5.2 | Secondary end point(s) |
1. HbA1c <7.0% (yes/no) 2. HbA1c ?6.5% (yes/no) 3. HbA1c <7.0% without severe or minor hypoglycaemic episodes (yes/no)
Change from baseline: 4. Fasting plasma glucose (FPG) 5. 7-point self-measured plasma glucose
Safety 6. Adverse events (AEs) and serious adverse events (SAEs) 7. Safety follow-up after 1 and 2 years: AEs and SAEs, growth velocity and pubertal progression |
1. HbA1c < 7,0 % (sí/no) 2. HbA1c ? 6,5 % (sí/no) 3. HbA1c < 7,0 % sin episodios de hipoglucemia intensa o leve (sí/no)
Variación desde el momento basal: 4. Glucosa plasmática en ayunas (GPA) 5. Glucosa plasmática medida por el propio paciente en 7 puntos temporales
Seguridad 6. Acontecimientos adversos (AA) y acontecimientos adversos graves (AAG) 7. Seguimiento de la seguridad después de 1 y 2 años: AA y AAG, velocidad de crecimiento y progresión de la pubertad |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoints 1-5: At 14, 26 and 52 weeks of treatment Endpoints 6-7: After 53 weeks, and after 1 and 2 years after LPLV |
Criterios de valoración 1-5: a 14, 26 y 52 semanas de tratamiento Criterios de valoración 6-7: tras 53 semanas y tras 1 año y 2 años después de la última visita del último paciente |
|
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 | 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 |
Seguido de una externsión abierta de 38 semanas |
Followed by 38-week open-label extension |
|
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.8.2.4 | 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 | 3 |
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 |
Austria |
Belgium |
Brazil |
Bulgaria |
Canada |
China |
Croatia |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
India |
Ireland |
Israel |
Italy |
Latvia |
Lithuania |
Macedonia, the former Yugoslav Republic of |
Mexico |
Netherlands |
Norway |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
Slovenia |
Spain |
Sweden |
Switzerland |
Turkey |
United Kingdom |
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
|
LVLS |
Última visita del último paciente (UVUP) |
|
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 | 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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |