Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity
15 de abril de 2020 actualizado por: Novo Nordisk A/S
Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug
This trial is conducted globally.
The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
251
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Brussels, Bélgica, 1090
- Novo Nordisk Investigational Site
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Brussels, Bélgica, 1200
- Novo Nordisk Investigational Site
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Edegem, Bélgica, 2650
- Novo Nordisk Investigational Site
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Hasselt, Bélgica, 3500
- Novo Nordisk Investigational Site
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Leuven, Bélgica, 3000
- Novo Nordisk Investigational Site
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Namur, Bélgica, 5000
- Novo Nordisk Investigational Site
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Idaho
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Meridian, Idaho, Estados Unidos, 83646
- Novo Nordisk Investigational Site
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808-4124
- Novo Nordisk Investigational Site
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Maryland
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Baltimore, Maryland, Estados Unidos, 21229
- Novo Nordisk Investigational Site
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- Novo Nordisk Investigational Site
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New York
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Buffalo, New York, Estados Unidos, 14222
- Novo Nordisk Investigational Site
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Ohio
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Columbus, Ohio, Estados Unidos, 43213
- Novo Nordisk Investigational Site
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Dayton, Ohio, Estados Unidos, 45406
- Novo Nordisk Investigational Site
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Dayton, Ohio, Estados Unidos, 45419
- Novo Nordisk Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Novo Nordisk Investigational Site
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Novo Nordisk Investigational Site
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Goose Creek, South Carolina, Estados Unidos, 29445
- Novo Nordisk Investigational Site
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Greenville, South Carolina, Estados Unidos, 29615
- Novo Nordisk Investigational Site
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38119
- Novo Nordisk Investigational Site
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Moscow, Federación Rusa, 125373
- Novo Nordisk Investigational Site
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Novosibirsk, Federación Rusa, 630048
- Novo Nordisk Investigational Site
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Rostov-on-Don, Federación Rusa, 344013
- Novo Nordisk Investigational Site
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Saint-Petersburg, Federación Rusa, 191144
- Novo Nordisk Investigational Site
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Samara, Federación Rusa, 443079
- Novo Nordisk Investigational Site
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Stavropol, Federación Rusa, 355035
- Novo Nordisk Investigational Site
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Tomsk, Federación Rusa, 634050
- Novo Nordisk Investigational Site
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Ufa, Federación Rusa, 450106
- Novo Nordisk Investigational Site
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Puebla, México, 72190
- Novo Nordisk Investigational Site
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Tamaulipas
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Ciudad Madero, Tamaulipas, México, 89440
- Novo Nordisk Investigational Site
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Göteborg, Suecia, 416 85
- Novo Nordisk Investigational Site
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Huddinge, Suecia, 141 57
- Novo Nordisk Investigational Site
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Malmö, Suecia, 205 02
- Novo Nordisk Investigational Site
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Uppsala, Suecia, 751 85
- Novo Nordisk Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 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
- Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
- BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
- Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
- History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record
Exclusion Criteria:
- Pre-pubertal subjects (Tanner stage 1) at screening V2
- Type 1 diabetes mellitus (T1DM)
- Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
- Medullary thyroid carcinoma (MTC)
- History of pancreatitis (acute or chronic)
- Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
- Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
- Anti-diabetic treatment other than metformin
- History of major depressive disorder within 2 years before screening V2
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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Administered once daily subcutaneously (s.c., under the skin)
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Experimental: Liraglutida
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Administered once daily subcutaneously (s.c., under the skin)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in BMI SDS (Week 0, Week 56)
Periodo de tiempo: Week 0, week 56
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Change from baseline (week 0) in BMI SDS was evaluated at week 56.
BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation.
Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.
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Week 0, week 56
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Periodo de tiempo: Weeks 30, 56 and 82
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Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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Weeks 30, 56 and 82
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Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Periodo de tiempo: Weeks 30, 56 and 82
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Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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Weeks 30, 56 and 82
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Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
Periodo de tiempo: (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
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Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82.
BMI SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age.
For each subject, a Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
All available data were used for the analysis including data collected after treatment discontinuation.
Results are based on both participants who completed the trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.
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(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
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Change in BMI
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Body Weight (kg)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Body Weight (%)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Body Weight (lb)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Body weight was not analysed in pounds (lb).
It was analysed for standard unit, 'kg' only.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Waist Circumference
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Waist-to-hip Circumference Ratio
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in hsCRP
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Lipid: FFA (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Systolic and Diastolic Blood Pressure
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in HbA1c
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in FPG
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting Insulin (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in fasting insulin from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Fasting C-peptide (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in fasting C-peptide from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Glycaemic Category
Periodo de tiempo: Week -2, week 30, week 56 and week 82
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Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" at baseline (weeks -2), and weeks 30, 56 and 82 are presented.
These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%.
2) Pre-diabetes: FPG 5.6-6.9
mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive).
3) Type 2 diabetes (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%.
Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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Week -2, week 30, week 56 and week 82
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Change in HOMA-B (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5).
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in HOMA-IR (Ratio to Baseline)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline.
HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in IWQOL-Kids
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
The IWQOL-Kids is a 27-item measure of weight-related quality of life.
There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score.
Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life.
IWQOL-kids data at week 82 was not collected, thus could not be evaluated.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in BMI SDS (%)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56)
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Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56.
Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
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(Week 0, week 30); (Week 0, week 56)
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Change in Nutritional Compliance
Periodo de tiempo: Week 0, week 30 and week 56
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This outcome measure presents "nutritional compliance results" recorded at baseline (week 0), week 30 and week 56.
Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance.
Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
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Week 0, week 30 and week 56
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Number of Treatment Emergent Adverse Events
Periodo de tiempo: Week 0-56 + 14 days
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A treatment emergent adverse event (TEAE) was defined as an event that occurred in the "on-treatment" period.
'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).
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Week 0-56 + 14 days
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Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
Periodo de tiempo: Week 0-56 + 14 days
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A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment.
Severe hypoglycaemia episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition.
And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.
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Week 0-56 + 14 days
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Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
Periodo de tiempo: Week 0-56 + 14 days
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Severe hypoglycaemia episodes were recorded as per the ISPAD definition.
And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia.
Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia.
4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia.
5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.
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Week 0-56 + 14 days
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Occurrence of Anti-liraglutide Antibodies
Periodo de tiempo: Weeks 0, 30, 56, 58, 70 and 82
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This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm.
Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.
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Weeks 0, 30, 56, 58, 70 and 82
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Change in Pulse
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in pulse was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in ECG
Periodo de tiempo: Week -14, week 30, week 56 and week 82
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This outcome measure presents number of subjects with electrocardiogram findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" recorded at baseline (week -14), week 30 and week 56.
These findings were categorised by the investigator.
Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated.
Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.
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Week -14, week 30, week 56 and week 82
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Change in Haematology: Haemoglobin
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in haemoglobin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Haematology: Haematocrit
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in haematocrit was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in haematological parameters, "thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Haematology: Erythrocytes
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in erythrocytes was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Biochemistry: Creatinine and Bilirubin (Total)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in creatinine and bilirubin (total) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in biochemistry parameters, "urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected" was evaluated from baseline (week [Wk] 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Biochemistry: Albumin
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in albumin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Biochemistry: CEA
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in carcinoembryonic antigen (CEA) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Hormone Level: Calcitonin
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in calcitonin was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Hormone Level: TSH and Prolactin
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in hormone levels, "thyroid stimulating hormone (TSH) and prolactin" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Hormone Level: Free T4 and ACTH
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in hormone levels, "thyroxine (T4) and adrenocorticotropic hormone (ACTH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Hormone Level: IGF-1 and Cortisol
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in hormone levels, "insulin-like growth factor-1 (IGF-1) and cortisol" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
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Change in Hormone Level: DHEAS
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in dehydroepiandrosterone sulfate (DHEAS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Hormone Level: LH and FSH
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in hormone levels, "luteinising hormone (LH) and follicle stimulating hormone (FSH)" was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
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Change in Hormone Level: Estradiol (Females)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in estradiol (only for female) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Hormone Level: Testosterone (Males)
Periodo de tiempo: Week 0, week 30, week 56 and week 82
|
This outcome measure presents "testosterone (only for males) results" for baseline (week 0), week 30, week 56 and week 82.
ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone.
Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
Week 0, week 30, week 56 and week 82
|
|
Change in NTX1
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are presented in "nmol bone collagen equivalents (BCE)/L".
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in CTX1
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in type I collagen C-telopeptide (CTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in P1NP
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in procollagen 1 N-terminal propeptide (P1NP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in Alkaline Phosphatase (Bone)
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in alkaline phosphatase (bone specific) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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|
Change in Pubertal Status
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
This outcome measure presents "pubertal status results" which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82.
Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging).
2) For male: penis development and pubic hair development (by Tanner staging).
Each category shows number of participants in stages 2 to 5, where stage 2 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult".
Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Change in Physical Examination
Periodo de tiempo: Week 0, week 30, week 56 and week 82
|
This outcome measure presents number of subjects with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 30, week 56 and week 82.
These findings were categorised by the investigator.
Results include examination of: "general appearance"; "head, ears, eyes, nose, throat, neck"; "respiratory system"; "cardiovascular system (CVS)"; "gastrointestinal (GI) system including mouth"; "musculoskeletal system"; "central nervous system (CNS) and peripheral nervous system (PNS)"; "skin"; "thyroid gland" and "lymph node palpation".
Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
Week 0, week 30, week 56 and week 82
|
|
Change in Height SDS
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
Height SDS was calculated using the following formula: Z=[(value /M)^L - 1] / S*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' height provided for each sex and age.
For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the WHO Multicentre Growth Reference, which also contains the values for L, M and S by age and sex.
For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction.
Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.
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(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in C-SSRS
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
This outcome measure presents number of subjects with "suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS)" assessed at baseline (week 0), week 30, week 56 and week 82.
Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
|
Change in PHQ-9
Periodo de tiempo: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
|
Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82.
The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders.
The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression.
Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.
|
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Global Clinical Registry (GCR), Novo Nordisk A/S
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de septiembre de 2016
Finalización primaria (Actual)
14 de febrero de 2019
Finalización del estudio (Actual)
8 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
27 de septiembre de 2016
Primero enviado que cumplió con los criterios de control de calidad
27 de septiembre de 2016
Publicado por primera vez (Estimar)
28 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN8022-4180
- 2014-004353-14 (Número EudraCT)
- U1111-1162-7101 (Otro identificador: WHO)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .