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A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD) (DUAL™ II China)

18 de março de 2020 atualizado por: Novo Nordisk A/S

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD

This trial is conducted in Asia. The aim of this trial is to confirm the superiority of insulin degludec/liraglutide versus insulin degludec in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus after 26 weeks of treatment

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

453

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

China
- Anhui
  - Hefei, Anhui, China, 230001
    - Novo Nordisk Investigational Site
  - Hefei, Anhui, China, 230061
    - Novo Nordisk Investigational Site
- Beijing
  - Beijing, Beijing, China, 100730
    - Novo Nordisk Investigational Site
  - Beijing, Beijing, China, 100071
    - Novo Nordisk Investigational Site
  - Beijing, Beijing, China, 100088
    - Novo Nordisk Investigational Site
  - Beijing, Beijing, China, 100853
    - Novo Nordisk Investigational Site
- Chongqing
  - ChongQing, Chongqing, China, 404000
    - Novo Nordisk Investigational Site
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Novo Nordisk Investigational Site
- Guangdong
  - Guangzhou, Guangdong, China, 510120
    - Novo Nordisk Investigational Site
  - Guangzhou, Guangdong, China, 510515
    - Novo Nordisk Investigational Site
- Hebei
  - Hengshui, Hebei, China, 053000
    - Novo Nordisk Investigational Site
  - Shijiazhuang, Hebei, China, 050000
    - Novo Nordisk Investigational Site
  - Tangshan, Hebei, China, 063000
    - Novo Nordisk Investigational Site
- Heilongjiang
  - Harbin, Heilongjiang, China, 150001
    - Novo Nordisk Investigational Site
- Hunan
  - Yueyang, Hunan, China, 414000
    - Novo Nordisk Investigational Site
- Inner Mongolia
  - Huhehaote, Inner Mongolia, China, 010020
    - Novo Nordisk Investigational Site
  - Huhhot, Inner Mongolia, China, 010050
    - Novo Nordisk Investigational Site
- Jiangsu
  - Changzhou, Jiangsu, China, 213003
    - Novo Nordisk Investigational Site
  - Nanjing, Jiangsu, China, 210011
    - Novo Nordisk Investigational Site
  - Nanjing, Jiangsu, China, 210012
    - Novo Nordisk Investigational Site
  - Nanjing, Jiangsu, China, 210029
    - Novo Nordisk Investigational Site
  - Zhenjiang, Jiangsu, China, 212001
    - Novo Nordisk Investigational Site
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Novo Nordisk Investigational Site
- Jilin
  - Changchun, Jilin, China, 130021
    - Novo Nordisk Investigational Site
  - Changchun, Jilin, China, 130033
    - Novo Nordisk Investigational Site
  - Siping, Jilin, China, 136000
    - Novo Nordisk Investigational Site
- Liaoning
  - Dalian, Liaoning, China, 116011
    - Novo Nordisk Investigational Site
- Ningxia
  - Yinchuan, Ningxia, China, 750004
    - Novo Nordisk Investigational Site
- Shaanxi
  - Xi'an, Shaanxi, China, 710061
    - Novo Nordisk Investigational Site
- Shanghai
  - Shanghai, Shanghai, China, 200240
    - Novo Nordisk Investigational Site
  - Shanghai, Shanghai, China, 200040
    - Novo Nordisk Investigational Site
  - Shanghai, Shanghai, China, 200072
    - Novo Nordisk Investigational Site
  - Shanghai, Shanghai, China, 201199
    - Novo Nordisk Investigational Site
- Shanxi
  - Taiyuan, Shanxi, China, 030001
    - Novo Nordisk Investigational Site
- Tianjin
  - Tianjin, Tianjin, China, 300052
    - Novo Nordisk Investigational Site
- Yunnan
  - Kunming, Yunnan, China, 650101
    - Novo Nordisk Investigational Site
Hong Kong
- - Shatin, New Territories, Hong Kong
    - Novo Nordisk Investigational Site

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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 procedures to determine suitability for the trial - Male or female, age at least 18 years at the time of signing inform consent - Type 2 diabetes mellitus (clinically diagnosed) - HbA1c (glycosylated haemoglobin) above or equal to 7.5% by central laboratory analysis, with the aim of a median of 8.5%. When approximately 50% of the randomised subjects have an HbA1c above 8.5%, the remaining subjects randomised must have an HbA1c below or equal to 8.5% or when approximately 50% of the subjects randomised have an HbA1c below or equal to 8.5%, the remaining subjects randomised must have an HbA1c above 8.5% - Current treatment for at least 90 calendar days prior to screening with basal insulin plus metformin plus/minus α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. Subjects should be on a stable dose for at least 60 calendar days prior to screening of: Basal insulin 20-50 units (U)/day (both inclusive) ( Individual fluctuations of plus/minus 5U during the 60 day period prior to the day of screening are acceptable.) on the day of screening in combination with: - Metformin (above or equal to 1500 mg or max tolerated dose) or - Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and glinide (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (AGI) (at least half of the max approved dose according to local label) or - Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (at least half of the max approved dose according to local label) - Body mass index (BMI) above or equal to 24 kg/m^2 Exclusion Criteria: Current use of any antidiabetic drug (except for basal insulin, metformin, α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones) or anticipated change in concomitant medication, that in the investigator´s opinion could interfere with glucose level (e.g. systemic corticosteroids) - Treatment with glucagon like peptide -1 receptor agonists, or dipeptidyl-peptidase-4 inhibitors or insulin (except for basal insulin) within 90 days prior to Visit 1 - Impaired liver function defined as alanine aminotransferase above or equal to 2.5 times upper normal range - Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures - Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg or diastolic blood pressure above or equal to 100 mm Hg) - Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment - History of pancreatitis (acute or chronic)

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: Dobro

Armas e Intervenções

Grupo de Participantes / Braço Grupo de Participantes / Braço Um grupo ou subgrupo de participantes em um estudo clínico que recebe uma intervenção/tratamento específico, ou nenhuma intervenção, de acordo com o protocolo do estudo.	Intervenção / Tratamento Intervenção / Tratamento Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.
Experimental: Insulina degludeca/liraglutida	Medicamento: Insulin degludec/liraglutide Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Comparador Ativo: Insulina degludeca	Medicamento: Insulin degludec Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Change in HbA1c Prazo: Week 0, week 26	Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.	Week 0, week 26

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Change in Body Weight Prazo: Week 0, week 26	Change in body weight from baseline (week 0) to week 26 is presented.	Week 0, week 26
Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes Prazo: Up to 26 weeks	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 millimoles per liter (mmol/L) with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed hypoglycaemic episodes during 26 weeks of treatment is presented.	Up to 26 weeks
Change in Fasting Plasma Glucose (FPG) Prazo: Week 0, week 26	Change in FPG from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Waist Circumference Prazo: Week 0, week 26	Change in waist circumference from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Mean of the 9-point Self-measured Plasma Glucose (SMPG) Profile Prazo: Week 0, week 26	Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. The mean of profile is defined as the area under the profile divided by measurement time and is calculated using the trapezoidal method. Change in mean of the 9-point SMPG profile from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in SMPG-mean Post Prandial Increments Prazo: Week 0, week 26	Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 is presented.	Week 0, week 26
Insulin Dose Prazo: Week 26	The mean of actual daily total insulin dose after 26 weeks of treatment is presented.	Week 26
SMPG-9-point Profile (Individual Points in the Profile) Prazo: Week 26	Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. SMPG-9-point profile (individual points in the profile) at week 26 is presented.	Week 26
Change in Fasting High-density Lipoprotein (HDL) Cholesterol- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting HDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Low-density Lipoprotein (LDL) Cholesterol- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting LDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting VLDL cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Total Cholesterol- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Triglycerides- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting triglycerides (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Free Fatty Acids- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting free fatty acids (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting C-peptide- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting C-peptide (measured in nanomoles per liter (nmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Insulin- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting insulin (measured in picomoles per liter (pmol/L)) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in Fasting Glucagon- Ratio to Baseline Prazo: Week 0, week 26	Change in fasting glucagon (measured in picograms per milliliter (pg/mL)) from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Change in HOMA-B (Beta-cell Function)- Ratio to Baseline Prazo: Week 0, week 26	Change in HOMA-B from baseline (week 0) to week 26 is presented as ratio to baseline.	Week 0, week 26
Participants Who Achieved HbA1c < 7.0%, ADA Target (Yes/no) Prazo: Week 26	Participants who achieved HbA1c < 7.0%, ADA target (yes/no) is presented.	Week 26
Participants Who Achieved HbA1c ≤ 6.5%, American Association of Clinical Endocrinologists (AACE) Target (Yes/no) Prazo: Week 26	Participants who achieved HbA1c ≤ 6.5%, AACE target (yes/no) is presented.	Week 26
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero Prazo: Week 26	Participants who achieved HbA1c < 7.0% and change from baseline in body weight below or equal to zero is presented.	Week 26
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero Prazo: Week 26	Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero is presented.	Week 26
Participants Who Achieved HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes Prazo: Week 26	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c < 7.0% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.	Week 26
Participants Who Achieved HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes Prazo: Week 26	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% at week 26 without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.	Week 26
Participants Who Achieved HbA1c < 7.0% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes Prazo: Week 26	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c < 7.0% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.	Week 26
Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero and Without Treatment-emergent Severe or BG Confirmed Hypoglycaemic Episodes Prazo: Week 26	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Participants who achieved HbA1c ≤ 6.5% and change from baseline in body weight below or equal to zero and without treatment-emergent severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment is presented.	Week 26
Number of Treatment-emergent Adverse Events (TEAEs) Prazo: Weeks 0-27	A TEAE was defined as an adverse event with onset date on or after the first day of exposure to randomised treatment and no later than seven days after the last day of randomised treatment. If the event had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last drug date, then this event was considered as a TEAE.	Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes Prazo: Weeks 0-27	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with or without symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed hypoglycaemic episodes is presented.	Weeks 0-27
Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes Prazo: Weeks 0-27	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes is presented.	Weeks 0-27
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes Prazo: Weeks 0-27	Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value < 3.1 mmol/L with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 a.m. both inclusive. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes is presented.	Weeks 0-27
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition Prazo: Weeks 0-27	Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA definition is presented.	Weeks 0-27
Change in Physical Examination Prazo: Week -2, week 26	Physical examination parameters are categorised as cardiovascular system; central and peripheral nervous system; gastrointestinal system including mouth; general appearance; head, ears, eyes, nose, throat, neck; lymph node palpation; musculoskeletal system; respiratory system; skin and thyroid gland. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at week -2 and week 26 is presented.	Week -2, week 26
Eye Examination Prazo: Week -2, week 26	Dilated fundoscopy or fundus photography was performed by the investigator at week -2 and week 26. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at week -2 and week 26 were presented.	Week -2, week 26
Change in Electrocardiogram (ECG) Prazo: Week -2, week 26	The ECG was assessed by the investigator at baseline (week -2) and week 26 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 26 were presented.	Week -2, week 26
Change in Pulse Prazo: Week 0, week 26	Change in pulse from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Blood Pressure (Systolic and Diastolic Blood Pressure) Prazo: Week 0, week 26	Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Biochemical Parameter- Amylase, Lipase, Creatinine Kinase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) Prazo: Week 0, week 26	Change in amylase, lipase, creatinine kinase, ALT, AST, ALP from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Biochemical Parameter-calcium (Total), Albumin Corrected Calcium, Potassium, Sodium, Urea Prazo: Week 0, week 26	Change in calcium (total), albumin corrected calcium, potassium, sodium, urea from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Albumin Prazo: Week 0, week 26	Change in albumin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Bilirubin Prazo: Week 0, week 26	Change in total bilirubin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Creatinine Prazo: Week 0, week 26	Change in creatinine from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Protein Prazo: Week 0, week 26	Change in total protein from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Haematocrit Prazo: Week 0, week 26	Change in haematocrit from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Haemoglobin Prazo: Week 0, week 26	Change in haemoglobin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Leukocytes and Thrombocytes Prazo: Week 0, week 26	Change in leukocytes and thrombocytes from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Erythrocytes Prazo: Week 0, week 26	Change in erythrocytes from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Basophils Prazo: Week 0, week 26	Change in basophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Eosinophils Prazo: Week 0, week 26	Change in eosinophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Lymphocytes Prazo: Week 0, week 26	Change in lymphocytes from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Monocytes Prazo: Week 0, week 26	Change in monocytes from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Haematological Parameter- Neutrophils Prazo: Week 0, week 26	Change in neutrophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Calcitonin Prazo: Week 0, week 26	Calcitonin levels were measured and were categorised as low, normal or high. Number of participants in each category at week 0 and week 26 were presented.	Week 0, week 26
Urinalysis (Erythrocytes, Protein, Glucose and Ketones) Prazo: Week 0, week 26	The urinalysis was the measurements of protein, glucose, erythrocytes and ketones at week 0 and week 26 and categorised as negative, trace, 1+, 2+ and 3+. Number of participants in each category at week 0 and week 26 are presented.	Week 0, week 26
Anti-insulin Degludec Specific Antibodies Prazo: Week 27	Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).	Week 27
Antibodies Cross-reacting to Human Insulin Prazo: Week 27	Serum samples were analysed for the presence of antibodies cross-reacting to human insulin. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).	Week 27
Total Insulin Antibodies Prazo: Week 27	Serum samples were analysed for the presence of total insulin antibodies. Results are presented as percentage of bound radioactivity-labelled insulin/total added radioactivity-labelled insulin (%B/T).	Week 27
Occurrence of Anti-liraglutide Antibodies (Yes/no) Prazo: Week 27	This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies at week 27 are presented.	Week 27
Occurrence of Anti-liraglutide Antibodies Cross Reacting Native Glucagon-like Peptide-1 (GLP-1) Prazo: Week 27	This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.	Week 27
Occurrence of Neutralising Liraglutide Antibodies Prazo: Week 27	This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented.	Week 27
Occurrence of Neutralising Liraglutide Antibodies Cross Reacting Native GLP-1 Prazo: Week 27	This outcome measure is only applicable for the Insulin degludec/liraglutide treatment arm. Number of participants who measured with neutralising liraglutide antibodies cross reacting native GLP-1 at week 27 are presented.	Week 27

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Novo Nordisk A/S

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)

26 de maio de 2017

Conclusão Primária (Real)

5 de março de 2019

Conclusão do estudo (Real)

4 de abril de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

24 de maio de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2017

Primeira postagem (Real)

5 de junho de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de março de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

NN9068-4166
U1111-1154-6732 (Outro identificador: World Health Organization (WHO))
CTR20060909 (Identificador de registro: China Drug Trials (China))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Sim

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

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Ensaios clínicos em Insulin degludec/liraglutide

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Diabetes Mellitus, Tipo 2
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Recrutamento

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Diabetes tipo 2
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Macho Adulto Saudável
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Diabetes tipo 2
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Concluído

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Diabetes mellitus tipo 2
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Concluído

Controle glicêmico de insulina basal com DEglugec vs Aspart via bomba (BIG LEAP)

Diabetes Mellitus tipo 1
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Concluído

Análise Metabólica na Deficiência de Aminoácido Enxofre Humano

Doenças cardíacas | Diabetes | Estresse oxidativo
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Rescindido

Insulina Degludeca para o Tratamento de Pacientes com Cetoacidose Diabética Recorrente

Diabetes Mellitus

A Trial Comparing Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other Oral Antidiabetic Drug (OAD) (DUAL™ II China)

A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Combination With Metformin in Chinese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin Therapy and Metformin With or Without One Other OAD

Visão geral do estudo

Status

Condições

Intervenção / Tratamento

Tipo de estudo

Inscrição (Real)

Estágio

Contactos e Locais

Locais de estudo

Critérios de participação

Critérios de elegibilidade

Idades elegíveis para estudo

Aceita Voluntários Saudáveis

Gêneros Elegíveis para o Estudo

Descrição

Plano de estudo

Como o estudo é projetado?

Detalhes do projeto

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço

Intervenção / Tratamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado

Descrição da medida

Prazo

Medidas de resultados secundários

Medida de resultado

Descrição da medida

Prazo

Colaboradores e Investigadores

Patrocinador

Datas de registro do estudo

Datas Principais do Estudo

Início do estudo (Real)

Conclusão Primária (Real)

Conclusão do estudo (Real)

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez que atendeu aos critérios de CQ

Primeira postagem (Real)

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última verificação

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

produto fabricado e exportado dos EUA

Ensaios clínicos em Insulin degludec/liraglutide

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações