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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 marzo 2020 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

453

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Trattamento
Assegnazione: Randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm Gruppo di partecipanti / Arm Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.	Intervento / Trattamento Intervento / Trattamento Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Sperimentale: Insulina degludec/liraglutide	Droga: Insulin degludec/liraglutide Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in HbA1c Lasso di tempo: Week 0, week 26	Change in glycosylated haemoglobin (HbA1c) from baseline (week 0) to week 26 is presented.	Week 0, week 26

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in Body Weight Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: Week 0, week 26	Change in FPG from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Waist Circumference Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Week 0, week 26	Change in albumin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Bilirubin Lasso di tempo: Week 0, week 26	Change in total bilirubin from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Creatinine Lasso di tempo: Week 0, week 26	Change in creatinine from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Total Protein Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: Week 0, week 26	Change in neutrophils from baseline (week 0) to week 26 is presented.	Week 0, week 26
Change in Calcitonin Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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) Lasso di tempo: 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) Lasso di tempo: 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 Lasso di tempo: 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 Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novo Nordisk A/S

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 maggio 2017

Completamento primario (Effettivo)

5 marzo 2019

Completamento dello studio (Effettivo)

4 aprile 2019

Date di iscrizione allo studio

Primo inviato

24 maggio 2017

Primo inviato che soddisfa i criteri di controllo qualità

2 giugno 2017

Primo Inserito (Effettivo)

5 giugno 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

NN9068-4166
U1111-1154-6732 (Altro identificatore: World Health Organization (WHO))
CTR20060909 (Identificatore di registro: China Drug Trials (China))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Sì

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Diabete
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Completato

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Diabete di tipo 1
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Reclutamento

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Diabete di tipo 2
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Completato

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Diabete mellito, tipo 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

Panoramica dello studio

Stato

Condizioni

Intervento / Trattamento

Tipo di studio

Iscrizione (Effettivo)

Fase

Contatti e Sedi

Luoghi di studio

Criteri di partecipazione

Criteri di ammissibilità

Età idonea allo studio

Accetta volontari sani

Sessi ammissibili allo studio

Descrizione

Piano di studio

Come è strutturato lo studio?

Dettagli di progettazione

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm

Intervento / Trattamento

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Misure di risultato secondarie

Misura del risultato

Misura Descrizione

Lasso di tempo

Collaboratori e investigatori

Sponsor

Studiare le date dei record

Studia le date principali

Inizio studio (Effettivo)

Completamento primario (Effettivo)

Completamento dello studio (Effettivo)

Date di iscrizione allo studio

Primo inviato

Primo inviato che soddisfa i criteri di controllo qualità

Primo Inserito (Effettivo)

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo verificato

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

prodotto fabbricato ed esportato dagli Stati Uniti

Prove cliniche su Insulin degludec/liraglutide

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi