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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 marca 2020 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

453

Faza

Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm Grupa uczestników / Arm Grupa lub podgrupa uczestników badania klinicznego, którzy zgodnie z protokołem badania otrzymują określoną interwencję/leczenie lub nie otrzymują żadnej interwencji.	Interwencja / Leczenie Interwencja / Leczenie Proces lub działanie będące przedmiotem badania klinicznego. Interwencje obejmują leki, urządzenia medyczne, procedury, szczepionki i inne produkty, które są w fazie badań lub są już dostępne. Interwencje mogą również obejmować podejścia nieinwazyjne, takie jak edukacja lub modyfikacja diety i ćwiczeń.
Eksperymentalny: Insulina degludec/liraglutyd	Lek: Insulin degludec/liraglutide Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Aktywny komparator: Insulina degludec	Lek: Insulin degludec Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Change in HbA1c Ramy czasowe: Week 0, week 26	Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.	Week 0, week 26

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Change in Body Weight Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: Week 0, week 26	Change in FPG from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Waist Circumference Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: Week 0, week 26	Change in albumin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Bilirubin Ramy czasowe: Week 0, week 26	Change in total bilirubin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Creatinine Ramy czasowe: Week 0, week 26	Change in creatinine from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Protein Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: Week 0, week 26	Change in neutrophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Calcitonin Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

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Sponsor

Novo Nordisk A/S

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

26 maja 2017

Zakończenie podstawowe (Rzeczywisty)

5 marca 2019

Ukończenie studiów (Rzeczywisty)

4 kwietnia 2019

Daty rejestracji na studia

Pierwszy przesłany

24 maja 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 czerwca 2017

Pierwszy wysłany (Rzeczywisty)

5 czerwca 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 marca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 marca 2020

Ostatnia weryfikacja

1 marca 2020

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

NN9068-4166
U1111-1154-6732 (Inny identyfikator: World Health Organization (WHO))
CTR20060909 (Identyfikator rejestru: China Drug Trials (China))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Cukrzyca typu 2

NCT07096804

Jeszcze nie rekrutacja

Wpływ postu Ramadan na dzieci z cukrzycą typu 1

Diabtes Mellitus Type 1
NCT05338125

Zakończony

Elektrofizjologia ludzkiej przysadki mózgowej

Gruczolak przysadki | Guz przysadki | Diabetes Insipidus Cranial Type | Dokrewny; Niedobór
NCT07344324

Jeszcze nie rekrutacja

Badanie oceniające bezpieczeństwo i możliwość zastosowania endoskopowych iniekcji do dwunastnicy autologicznych komórek mezenchymalnych (STEM-DM)

Otyłość | Cukrzyca typu 2 | Cukrzyca insulinoodporna (Mellitus)
NCT05687474

Zakończony

Wykrywanie dziecka: badanie przesiewowe noworodków genomowych (BabyDetect)

Wrodzony przerost nadnerczy | Hemofilia A | Hemofilia B | Mukopolisacharydoza I | Mukopolisacharydoza II | Mukowiscydoza | Niedobór alfa 1-antytrypsyny | Anemia sierpowata | Anemia Fanconiego | Przewlekła choroba ziarniniakowa
NCT06065852

Rekrutacyjny

Krajowy Rejestr Rzadkich Chorób Nerek (RaDaR)

Zapalenie naczyń | AL Amyloidoza | Stwardnienie guzowate | Choroba Fabry'ego | Cystynuria | Ogniskowe segmentowe stwardnienie kłębuszków nerkowych | Nefropatia IgA | Syndrom Barttera | Czysta aplazja czerwonokrwinkowa | Nefropatia błoniasta

Badania kliniczne na Insulin degludec/liraglutide

NCT07527078

Jeszcze nie rekrutacja

Ocena skuteczności i bezpieczeństwa preparatu GZR33 w iniekcji u pacjentów z cukrzycą typu 2

Cukrzyca typu 2 (T2DM)
NCT03938740

Zakończony

Porównanie różnych algorytmów dawkowania insuliny przy użyciu pęcherzyków kierowanych do wątroby — insuliny Lispro i insuliny Degludec

Cukrzyca typu 1
NCT06925334

Rejestracja na zaproszenie

Badanie porównujące insulinę degu insulinę liraglutydową z preparowaną insuliną na rokowaniu cukrzycy (TLI vs PMI)

Pacjenci z cukrzycą typu 2
NCT07173712

Jeszcze nie rekrutacja

Przejście schematu po krótkoterminowej intensywnej terapii insulinowej w cukrzycy typu 2

Cukrzyca typu 2
NCT04292535

Zakończony

Bezpieczeństwo i skuteczność łączenia insuliny donosowej i ostrych ćwiczeń

Ćwiczenie | Insulina
NCT07004153

Jeszcze nie rekrutacja

Badanie Dia: Conn P8 Smart Insulin Pen z coachingiem opartym na CGM u pacjentów z cukrzycą typu 1 lub 2

Cukrzyca
NCT07478497

Rekrutacyjny

30-dniowy protokół optymalizacji zdrowia metabolicznego z równowagą insulinową

Insulina
NCT07215312

Rekrutacyjny

Badanie LY3938577 u uczestników chorych na cukrzycę typu 2 wcześniej leczonych insuliną bazową

Cukrzyca typu 2
NCT07146347

Rekrutacyjny

Badanie porównawcze insuliny GZR4 z insuliną degludec

Cukrzyca typu 2
NCT07341373

Rekrutacyjny

Jednorazowe podanie bolusowe, 12-godzinne badanie euglikemicznego clampu dotyczące bezpieczeństwa, farmakokinetyki (PK) i glukodynamiki (GD) insuliny U-500 podawanej dootrzewnowo (IP) do żyły wrotnej

Cukrzyca typu 1

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

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Typ studiów

Zapisy (Rzeczywisty)

Faza

Kontakty i lokalizacje

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Rzeczywisty)

Ukończenie studiów (Rzeczywisty)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA

produkt wyprodukowany i wyeksportowany z USA

Badania kliniczne na Cukrzyca typu 2

Badania kliniczne na Insulin degludec/liraglutide

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje