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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. března 2020 aktualizováno: 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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

453

Fáze

Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: Inzulin degludek/liraglutid	Lék: Insulin degludec/liraglutide Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Aktivní komparátor: Inzulin degludek	Lék: Insulin degludec Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change in HbA1c Časové okno: Week 0, week 26	Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.	Week 0, week 26

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Change in Body Weight Časové okno: 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 Časové okno: 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) Časové okno: Week 0, week 26	Change in FPG from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Waist Circumference Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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 Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: Week 0, week 26	Change in albumin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Bilirubin Časové okno: Week 0, week 26	Change in total bilirubin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Creatinine Časové okno: Week 0, week 26	Change in creatinine from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Protein Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: Week 0, week 26	Change in neutrophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Calcitonin Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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) Časové okno: 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) Časové okno: 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 Časové okno: 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 Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Novo Nordisk A/S

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

26. května 2017

Primární dokončení (Aktuální)

5. března 2019

Dokončení studie (Aktuální)

4. dubna 2019

Termíny zápisu do studia

První předloženo

24. května 2017

První předloženo, které splnilo kritéria kontroly kvality

2. června 2017

První zveřejněno (Aktuální)

5. června 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. března 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. března 2020

Naposledy ověřeno

1. března 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NN9068-4166
U1111-1154-6732 (Jiný identifikátor: World Health Organization (WHO))
CTR20060909 (Identifikátor registru: China Drug Trials (China))

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ano

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

produkt vyrobený a vyvážený z USA

Ano

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Přehled studie

Postavení

Podmínky

Intervence / Léčba

Typ studie

Zápis (Aktuální)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Aktuální)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA

produkt vyrobený a vyvážený z USA

Klinické studie na Diabetes mellitus, typ 2

Klinické studie na Insulin degludec/liraglutide

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa