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 julho de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
635
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Annaka-shi, Gunma, Japão, 379 0116
- Novo Nordisk Investigational Site
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Chitose, Hokkaido, Japão, 066-0032
- Novo Nordisk Investigational Site
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Chuo-ku Tokyo, Japão, 103-0027
- Novo Nordisk Investigational Site
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Chuo-ku,, Japão, 104 0061
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japão, 103 0027
- Novo Nordisk Investigational Site
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Chuo-ku, Tokyo, Japão, 103 0002
- Novo Nordisk Investigational Site
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Fukuoka-shi, Fukuoka, Japão
- Novo Nordisk Investigational Site
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Higashiosaka-shi, Osaka, Japão
- Novo Nordisk Investigational Site
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Hokkaido, Japão, 078-8236
- Novo Nordisk Investigational Site
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Ichikawa-shi, Chiba, Japão
- Novo Nordisk Investigational Site
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Iruma-shi, Saitama, Japão, 358 0011
- Novo Nordisk Investigational Site
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Izumisano-shi, Japão, 598 0048
- Novo Nordisk Investigational Site
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Kashiwara-shi, Osaka, Japão, 582 0005
- Novo Nordisk Investigational Site
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Kawagoe-shi, Saitama, Japão, 350 0851
- Novo Nordisk Investigational Site
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Kobe-shi, Hyogo, Japão
- Novo Nordisk Investigational Site
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Kumamoto-shi,Kumamoto, Japão, 862 0976
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, Japão, 310-0845
- Novo Nordisk Investigational Site
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Mito-shi, Ibaraki, Japão
- Novo Nordisk Investigational Site
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Miyazaki-shi, Japão, 880 0034
- Novo Nordisk Investigational Site
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Naka-shi, Ibaraki, Japão, 311 0113
- Novo Nordisk Investigational Site
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Neyagawa-shi, Osaka, Japão
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hygo, Japão, 662 0971
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Hyogo, Japão, 663-8501
- Novo Nordisk Investigational Site
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Oita-shi, Japão, 870 0039
- Novo Nordisk Investigational Site
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Okawa-shi, Fukuoka, Japão, 831 0016
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, Japão, 553 0003
- Novo Nordisk Investigational Site
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Osaka-shi, Osaka, Japão, 5590012
- Novo Nordisk Investigational Site
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Oyama-shi, Tochigi, Japão, 323 0022
- Novo Nordisk Investigational Site
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Saga-shi,Saga, Japão, 849 0937
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japão, 060 0062
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japão, 060-0001
- Novo Nordisk Investigational Site
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Sapporo-shi, Hokkaido, Japão, 062 0007
- Novo Nordisk Investigational Site
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Sappro-shi, Hokkaido, Japão, 060 8648
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japão, 329 0433
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, Japão, 160-0008
- Novo Nordisk Investigational Site
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Shizuoka-shi, Japão, 424 0853
- Novo Nordisk Investigational Site
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Suita-shi, Osaka, Japão, 565-0853
- Novo Nordisk Investigational Site
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Takatsuki-shi, Osaka, Japão, 569 1096
- Novo Nordisk Investigational Site
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Tokyo, Japão, 181-0013
- Novo Nordisk Investigational Site
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Tokyo, Japão, 103-0028
- Novo Nordisk Investigational Site
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Tokyo, Japão, 169-0073
- Novo Nordisk Investigational Site
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Tokyo, Japão, 105-8471
- Novo Nordisk Investigational Site
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Tokyo, Japão, 123-0845
- Novo Nordisk Investigational Site
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Tokyo, Japão, 144-0051
- Novo Nordisk Investigational Site
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Yokohama, Kanagawa, Japão, 236-0004
- Novo Nordisk Investigational Site
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Yokohama-shi, Japão, 235 0045
- Novo Nordisk Investigational Site
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Yokohama-shi Kanagawa, Japão, 232-0064
- Novo Nordisk Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in HbA1c (Week 52)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de julho de 2015
Conclusão Primária (Real)
2 de maio de 2017
Conclusão do estudo (Real)
9 de novembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2015
Primeira postagem (Estimativa)
22 de julho de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de setembro de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2018
Última verificação
1 de julho de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NN2211-4174
- U1111-1164-5462 (Outro identificador: WHO)
- JapicCTI-152975 (Identificador de registro: JAPIC)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .