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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 marzo de 2020 actualizado 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

Descripción general del estudio

Estado

Estado

Indica el estado de contratación actual o el estado de acceso ampliado.
Terminado

Condiciones

Condiciones

La enfermedad, trastorno, síndrome, dolencia o lesión que se está estudiando. En ClinicalTrials.gov, las condiciones también pueden incluir otros problemas relacionados con la salud, como la esperanza de vida, la calidad de vida y los riesgos para la salud.

Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.

Tipo de estudio

Tipo de estudio

Describe la naturaleza de un estudio clínico. Los tipos de estudio incluyen estudios de intervención (también llamados ensayos clínicos), estudios observacionales (incluidos registros de pacientes) y acceso ampliado.
Intervencionista

Inscripción (Actual)

Inscripción

El número de participantes en un estudio clínico. La inscripción "anticipada" es el número objetivo de participantes que los investigadores necesitan para el estudio.
453

Fase

Fase

La etapa de un ensayo clínico que estudia un fármaco o producto biológico, según las definiciones desarrolladas por la Administración de Drogas y Alimentos de los Estados Unidos (FDA). La fase se basa en el objetivo del estudio, el número de participantes y otras características. Hay cinco fases: Fase 1 temprana (anteriormente enumerada como Fase 0), Fase 1, Fase 2, Fase 3 y Fase 4. No aplicable se usa para describir ensayos sin fases definidas por la FDA, incluidos ensayos de dispositivos o intervenciones conductuales.
  • 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

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

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

Criterio de elegibilidad

Los principales requisitos que deben cumplir las personas que quieran participar en un estudio clínico o las características que deben tener. Los criterios de elegibilidad consisten en criterios de inclusión (que se requieren para que una persona participe en el estudio) y criterios de exclusión (que impiden que una persona participe). Los tipos de criterios de elegibilidad incluyen si un estudio acepta voluntarios sanos, tiene requisitos de edad o grupo de edad, o está limitado por sexo.

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including 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)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo

Grupo de participantes/brazo

Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.
Intervención / Tratamiento

Intervención / Tratamiento

Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Experimental: Insulina degludec/liraglutida
Droga: Insulin degludec/liraglutide
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Comparador activo: Insulina degludec
Droga: Insulin degludec
Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medidas de resultado primarias

En el protocolo de un estudio clínico, la medida de resultado planificada que es la más importante para evaluar el efecto de una intervención/tratamiento. La mayoría de los estudios clínicos tienen una medida de resultado primaria, pero algunos tienen más de una.
Medida de resultado
Medida Descripción
Periodo de tiempo
Change in HbA1c
Periodo de tiempo: Week 0, week 26
Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.
Week 0, week 26

Medidas de resultado secundarias

Medidas de resultado secundarias

En el protocolo de un estudio clínico, una medida de resultado planificada que no es tan importante como la medida de resultado primaria para evaluar el efecto de una intervención pero que sigue siendo de interés. La mayoría de los estudios clínicos tienen más de una medida de resultado secundaria.
Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Body Weight
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Week 0, week 26
Change in FPG from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Waist Circumference
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 0, week 26
Change in albumin from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Total Bilirubin
Periodo de tiempo: Week 0, week 26
Change in total bilirubin from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Creatinine
Periodo de tiempo: Week 0, week 26
Change in creatinine from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Total Protein
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 0, week 26
Change in neutrophils from baseline (week 0) to week 26 is presented.
Week 0, week 26
Change in Calcitonin
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Patrocinador

La organización o persona que inicia el estudio y que tiene autoridad y control sobre el estudio.
Novo Nordisk A/S

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)

Inicio del estudio

La fecha real en la que el primer participante se inscribió en un estudio clínico. La fecha de inicio "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de inicio del estudio.
26 de mayo de 2017

Finalización primaria (Actual)

Finalización primaria

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención para recopilar datos finales para la medida de resultado primaria. Si el estudio clínico terminó de acuerdo con el protocolo o se terminó, no afecta esta fecha. Para estudios clínicos con más de una medida de resultado primaria con diferentes fechas de finalización, este término se refiere a la fecha en que se completa la recopilación de datos para todas las medidas de resultado primarias. La fecha de finalización principal "anticipada" es la fecha que los investigadores creen que será la fecha de finalización principal del estudio.
5 de marzo de 2019

Finalización del estudio (Actual)

Finalización del estudio

La fecha en la que el último participante en un estudio clínico fue examinado o recibió una intervención/tratamiento para recopilar los datos finales de las medidas de resultado primarias, las medidas de resultado secundarias y los eventos adversos (es decir, la última visita del último participante). La fecha de finalización "anticipada" del estudio es la fecha que los investigadores creen que será la fecha de finalización del estudio.
4 de abril de 2019

Fechas de registro del estudio

Enviado por primera vez

Enviado por primera vez

La fecha en la que el patrocinador o investigador del estudio envió por primera vez un registro del estudio a ClinicalTrials.gov. Por lo general, hay un retraso de unos días entre la primera fecha de envío y la disponibilidad del registro en ClinicalTrials.gov (la primera fecha publicada).
24 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

Primero enviado que cumplió con los criterios de control de calidad

La fecha en la que el patrocinador del estudio o el investigador envía por primera vez un registro del estudio que es consistente con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es posible que el patrocinador o el investigador deba revisar y enviar un registro de estudio una o más veces antes de que se cumplan los criterios de revisión de control de calidad de la NLM. Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
2 de junio de 2017

Publicado por primera vez (Actual)

Publicado por primera vez

La fecha en la que el registro del estudio estuvo disponible por primera vez en ClinicalTrials.gov después de que concluyó la revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Por lo general, hay una demora de unos días entre la fecha en que el patrocinador del estudio o el investigador envió el registro del estudio y la primera fecha publicada.
5 de junio de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

Última actualización publicada

La fecha más reciente en la que se pusieron a disposición los cambios en un registro del estudio en ClinicalTrials.gov. Puede haber una demora entre el momento en que el patrocinador o el investigador del estudio envió los cambios a ClinicalTrials.gov (la fecha de envío de la última actualización) y la fecha de publicación de la última actualización.
19 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

Última actualización enviada que cumplió con los criterios de control de calidad

La fecha más reciente en la que el patrocinador del estudio o el investigador presentó cambios en un registro del estudio que son consistentes con los criterios de revisión de control de calidad (QC) de la Biblioteca Nacional de Medicina (NLM). Es responsabilidad del patrocinador o investigador asegurarse de que el registro del estudio sea coherente con los criterios de revisión de control de calidad de la NLM.
18 de marzo de 2020

Última verificación

Última verificación

La fecha más reciente en la que el patrocinador o investigador del estudio confirmó que la información sobre un estudio clínico en ClinicalTrials.gov es precisa y actual. Si un estudio con un estado de reclutamiento de reclutamiento; aún no está reclutando; o activo, no se ha confirmado el reclutamiento en los últimos 2 años, el estado de reclutamiento del estudio se muestra como desconocido.
1 de marzo de 2020

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Otros números de identificación del estudio

Identificadores o números de identificación distintos del número NCT que el patrocinador del estudio, los financiadores u otros asignan a un estudio clínico. Estos números pueden incluir identificadores únicos de otros registros de ensayos y números de subvención de los Institutos Nacionales de Salud.
  • NN9068-4166
  • U1111-1154-6732 (Otro identificador: World Health Organization (WHO))
  • CTR20060909 (Identificador de registro: China Drug Trials (China))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Sí

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. .

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