A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus.
31 de julio de 2018 actualizado por: Novo Nordisk A/S
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus
This trial is conducted in Asia.
The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day in Japanese subjects with type 2 diabetes mellitus.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
635
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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Annaka-shi, Gunma, Japón, 379 0116
- Novo Nordisk Investigational Site
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Chitose, Hokkaido, Japón, 066-0032
- Novo Nordisk Investigational Site
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Chuo-ku Tokyo, Japón, 103-0027
- Novo Nordisk Investigational Site
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Chuo-ku,, Japón, 104 0061
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japón, 103 0027
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japón, 103 0002
- Novo Nordisk Investigational Site
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Fukuoka-shi, Fukuoka, Japón
- Novo Nordisk Investigational Site
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Higashiosaka-shi, Osaka, Japón
- Novo Nordisk Investigational Site
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Hokkaido, Japón, 078-8236
- Novo Nordisk Investigational Site
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Ichikawa-shi, Chiba, Japón
- Novo Nordisk Investigational Site
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Iruma-shi, Saitama, Japón, 358 0011
- Novo Nordisk Investigational Site
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Izumisano-shi, Japón, 598 0048
- Novo Nordisk Investigational Site
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Kashiwara-shi, Osaka, Japón, 582 0005
- Novo Nordisk Investigational Site
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Kawagoe-shi, Saitama, Japón, 350 0851
- Novo Nordisk Investigational Site
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Kobe-shi, Hyogo, Japón
- Novo Nordisk Investigational Site
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Kumamoto-shi,Kumamoto, Japón, 862 0976
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, Japón, 310-0845
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, Japón
- Novo Nordisk Investigational Site
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Miyazaki-shi, Japón, 880 0034
- Novo Nordisk Investigational Site
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Naka-shi, Ibaraki, Japón, 311 0113
- Novo Nordisk Investigational Site
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Neyagawa-shi, Osaka, Japón
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hygo, Japón, 662 0971
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hyogo, Japón, 663-8501
- Novo Nordisk Investigational Site
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Oita-shi, Japón, 870 0039
- Novo Nordisk Investigational Site
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Okawa-shi, Fukuoka, Japón, 831 0016
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, Japón, 553 0003
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, Japón, 5590012
- Novo Nordisk Investigational Site
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Oyama-shi, Tochigi, Japón, 323 0022
- Novo Nordisk Investigational Site
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Saga-shi,Saga, Japón, 849 0937
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japón, 060 0062
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japón, 060-0001
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japón, 062 0007
- Novo Nordisk Investigational Site
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Sappro-shi, Hokkaido, Japón, 060 8648
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japón, 329 0433
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, Japón, 160-0008
- Novo Nordisk Investigational Site
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Shizuoka-shi, Japón, 424 0853
- Novo Nordisk Investigational Site
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Suita-shi, Osaka, Japón, 565-0853
- Novo Nordisk Investigational Site
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Takatsuki-shi, Osaka, Japón, 569 1096
- Novo Nordisk Investigational Site
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Tokyo, Japón, 181-0013
- Novo Nordisk Investigational Site
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Tokyo, Japón, 103-0028
- Novo Nordisk Investigational Site
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Tokyo, Japón, 169-0073
- Novo Nordisk Investigational Site
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Tokyo, Japón, 105-8471
- Novo Nordisk Investigational Site
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Tokyo, Japón, 123-0845
- Novo Nordisk Investigational Site
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Tokyo, Japón, 144-0051
- Novo Nordisk Investigational Site
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Yokohama, Kanagawa, Japón, 236-0004
- Novo Nordisk Investigational Site
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Yokohama-shi, Japón, 235 0045
- Novo Nordisk Investigational Site
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Yokohama-shi Kanagawa, Japón, 232-0064
- 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
20 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female Japanese subjects at least 20 years of age at the time of informed consent
- Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
- HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)
- Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling
Exclusion Criteria:
- Treatment with insulin within 12 weeks prior to screening
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
- Screening calcitonin equal or above 50 ng/l
- History of pancreatitis (acute or chronic)
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV
- Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
- Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
- Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Liraglutide 1.8 mg
The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.
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Injected subcutaneously s.c.
(under the skin) once daily.
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Comparador activo: Liraglutide 0.9 mg
The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.
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Injected subcutaneously s.c.
(under the skin) once daily.
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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 Glycosylated Haemoglobin (HbA1c) (Week 26)
Periodo de tiempo: Week 0, Week 26
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Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment.
The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
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Week 0, Week 26
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in HbA1c (Week 52)
Periodo de tiempo: Week 0, Week 52
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Change from baseline (week 0) in HbA1c was evaluated after 52 weeks of treatment.
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Week 0, Week 52
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Responder for HbA1c Below 7.0% (53 mmol/Mol)
Periodo de tiempo: Week 26 and Week 52
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Reported results are number of subjects who achieved HbA1c target below 7.0% after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)
Periodo de tiempo: Week 26 and Week 52
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Reported results are number of subjects who achieved HbA1c target below or equal to 6.5% after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Responder for HbA1c Below 7.0% Without Weight Gain
Periodo de tiempo: Week 26 and Week 52
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Reported results are number of subjects who achieved HbA1c target below 7.0% without weight gain after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes
Periodo de tiempo: Week 26 and Week 52
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Reported results are subjects with HbA1c <7.0% after 26 weeks and 52 weeks of treatment, respectively without treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes.
Severe or BG confirmed symptomatic hypoglycaemia: severe as per ADA classification or BG confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia.
Severe hypoglycaemia as per ADA: episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions.
PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level.
Treatment emergent: episode with onset date on or after randomisation (from week (wk)0) and no later than 7 days after the last day on liraglutide (maximum till wk26+7days and wk52+7days).
Hence, the following shown 'Time Frame' should be read as 'Wk26+7days and Wk52+7days'
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Week 26 and Week 52
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Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)
Periodo de tiempo: Week 0 and Week 26 and Week 52
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Reported results are 7-point SMBG values at week 0, week 26 and week 52. The 7-point profile blood glucose levels were measured at the following time points always starting with the first:
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Week 0 and Week 26 and Week 52
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Change in SMBG 7-point Profile: Mean of 7-point Profile
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in mean of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in mean of postprandial increments (from before meal to 90 minutes after for breakfast, lunch and dinner) of the SMBG 7-point profile was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Fasting Plasma Glucose (FPG)
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in FPG was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Waist Circumference
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in waist circumference was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Body Weight
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in body weight was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Body Mass Index (BMI)
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in BMI was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Blood Pressure (Systolic and Diastolic)
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Fasting C-peptide
Periodo de tiempo: Week 26 and Week 52
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Fasting C-peptide was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Fasting Insulin
Periodo de tiempo: Week 26 and Week 52
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Fasting insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Fasting Glucagon
Periodo de tiempo: Week 26 and Week 52
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Fasting glucagon was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Proinsulin
Periodo de tiempo: Week 26 and Week 52
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Proinsulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Proinsulin/Insulin
Periodo de tiempo: Week 26 and Week 52
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Proinsulin/insulin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Homeostasis Model Assessment of Beta-cell Function (HOMA-B)
Periodo de tiempo: Week 26 and Week 52
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HOMA-B was evaluated after 26 weeks and 52 weeks of treatment, respectively.
HOMA-B is an index of beta-cell function and was calculated as: HOMA-B=[(20 x fasting insulin in µU/mL)/(FPG in mmol/L-3.5)].
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Week 26 and Week 52
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Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)
Periodo de tiempo: Week 26 and Week 52
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HOMA-IR was evaluated after 26 weeks and 52 weeks of treatment, respectively.
HOMA-IR is an index of insulin resistance and was calculated as: HOMA-IR= fasting insulin (μU/mL) x FPG (mmol/L)/22.5.
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Week 26 and Week 52
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Total Cholesterol
Periodo de tiempo: Week 26 and Week 52
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Total cholesterol was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Low Density Lipoprotein (LDL) Cholesterol
Periodo de tiempo: Week 26 and Week 52
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LDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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High Density Lipoprotein (HDL) Cholesterol
Periodo de tiempo: Week 26 and Week 52
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HDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Very Low Density Lipoprotein (VLDL) Cholesterol
Periodo de tiempo: Week 26 and Week 52
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VLDL was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Triglycerides
Periodo de tiempo: Week 26 and Week 52
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Triglycerides were evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Free Fatty Acids
Periodo de tiempo: Week 26 and Week 52
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Free fatty acids were evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 26 and Week 52
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Number of Treatment Emergent Adverse Events
Periodo de tiempo: Weeks 0-26 and Weeks 0-52
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Treatment emergent adverse events (TEAEs) were evaluated during the 26-week and 52-week treatment period, respectively.
TEAE for weeks 0-26: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 26 + 7 days).
TEAE for weeks 0-52: Event that has onset date on or after randomisation (from week 0) and no later than seven days after the last day on liraglutide (maximum till week 52 + 7 days).
Hence, the following shown 'Time Frame' should be read as 'Weeks 0-26 + 7 days and Weeks 0-52 + 7 days'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Periodo de tiempo: Weeks 0-26 and Weeks 0-52
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Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the 26-week and 52-week treatment period, respectively.
Severe or BG confirmed symptomatic hypoglycaemia (hypo):An episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypo.
ADA definition of severe hypo:episode requiring assistance of another person to actively administer carbohydrate/glucagon, or take other corrective actions.
PG levels may not be available during an event, but neurological recovery following the return of PG to normal is considered sufficient evidence that the event was induced by a low PG level.
Treatment emergent: episode with onset date on or after randomisation (from week (wk) 0) and no later than 7 days after the last day on liraglutide (maximum till wk 26 and wk 52, respectively + 7 days).
Hence, the following shown 'Time Frame' should be read as 'wk 0-26+7 days and wk 0-52+7 days'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes
Periodo de tiempo: Weeks 0-26 and Weeks 0-52
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Treatment emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes were evaluated during the26-week and 52-week treatment period, respectively.
Nocturnal hypoglycaemic episodes: Those occurring between 00:01 and 05:59 hours, both inclusive.
Severe or BG confirmed symptomatic hypoglycaemia: episode that was severe according to the ADA classification or BG confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia.
Treatment emergent: episode with onset date on or after randomisation (from week 0) and no later than 7 days after the last day on liraglutide (maximum till week 26 and week 52, respectively + 7 days).
Hence, the following shown 'Time Frame' should be read as 'Week 0-26 + 7 days and Week 0-52 + 7 days'.
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Weeks 0-26 and Weeks 0-52
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Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition
Periodo de tiempo: Weeks 0-26 and Weeks 0-52
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American Diabetes Association (ADA) classification of hypoglycaemia:
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Weeks 0-26 and Weeks 0-52
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Change in Pulse
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in pulse was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Physical Examination
Periodo de tiempo: Week 0 and Week 26 and Week 52
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Reported results are physical examination outcomes at week (wk) 0, wk 26 and wk 52. Physical examination consisted of the following listed examinations and the outcome of each examination was evaluated as: 1) normal, 2) abnormal, not clinically significant (NCS) or 3) abnormal, clinically significant (CS).
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Week 0 and Week 26 and Week 52
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Change in Eye Examination
Periodo de tiempo: Week 0 and Week 26 and Week 52
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Reported results are eye examination (ophthalmoscopy) outcomes at week 0, week 26 and week 52.
Ophthalmoscopy outcomes for both left and right eye were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
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Week 0 and Week 26 and Week 52
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Change in Electrocardiogram (ECG)
Periodo de tiempo: Week 0 and Week 26 and Week 52
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Reported results are ECG outcomes at week 0, week 26 and week 52.
ECG outcomes were evaluated as: 1) normal, 2) abnormal, NCS or 3) abnormal, CS.
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Week 0 and Week 26 and Week 52
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Change in Biochemistry: Creatinine
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in creatinine was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: eGFR
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in estimated glomerular filtration rate (eGFR) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
eGFR was evaluated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, mL/min/1.73m^2.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Alanine Aminotransferase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in alanine aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Aspartate Aminotransferase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in aspartate aminotransferase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Alkaline Phosphatase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in alkaline phosphatase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Sodium
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in sodium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Potassium
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in potassium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Albumin
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in albumin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Total Bilirubin
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in total bilirubin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Urea
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in urea was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Creatine Kinase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in creatine kinase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Calcium
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Albumin Corrected Calcium
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in albumin corrected calcium was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Amylase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in amylase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Biochemistry: Lipase
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in lipase was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Haematology: Haemoglobin
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in haemoglobin was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26, Week 52
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Change in Haematology: Haematocrit
Periodo de tiempo: Week 0, Week 26, Week 52
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Change from baseline (week 0) in haematocrit was evaluated after 26 weeks and 52 weeks of treatment, respectively.
Haematocrit is the ratio of the volume of red blood cells to the total volume of blood.
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Week 0, Week 26, Week 52
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Change in Haematology: Thrombocytes
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in thrombocytes (platelets) was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Erythrocytes
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in erythrocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Leukocytes
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in leukocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Eosinophils
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in eosinophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Neutrophils
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in neutrophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Basophils
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in basophils was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Monocytes
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in monocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Haematology: Lymphocytes
Periodo de tiempo: Week 0, Week 26 and Week 52
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Change from baseline (week 0) in lymphocytes was evaluated after 26 weeks and 52 weeks of treatment, respectively.
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Week 0, Week 26 and Week 52
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Change in Calcitonin
Periodo de tiempo: Week 0 and Week 26 and Week 52
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Reported results are number of subjects with low, normal or high calcitonin values at week 0, week 26 and week 52.
Number of subjects analyzed = number of subjects contributed to the analysis for individual time point.
Calcitonin values were categorised as low, normal or high.
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Week 0 and Week 26 and Week 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
Enlaces Útiles
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)
21 de julio de 2015
Finalización primaria (Actual)
2 de mayo de 2017
Finalización del estudio (Actual)
9 de noviembre de 2017
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2015
Publicado por primera vez (Estimar)
22 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de septiembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2018
Última verificación
1 de julio de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NN2211-4174
- U1111-1164-5462 (Otro identificador: WHO)
- JapicCTI-152975 (Identificador de registro: JAPIC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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. .