| Outcome Measures: |
Primary: Change in HbA1c, Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26 | Secondary: Change in Body Weight, Change in body weight from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes, 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 blood glucose (BG) confirmed by a plasma glucose (PG) 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. The number of episodes are represented as rates. The observed rates of treatment-emergent severe or BG confirmed hypoglycaemic episodes per patient years of exposure (PYE) (number of episodes divided by PYE multiplied by 100) during 26 weeks of treatment are presented., Weeks 0-26|Insulin Dose, The actual daily total insulin dose after 26 weeks of treatment is presented. This outcome measure is only applicable for Insulin degludec/liraglutide and Insulin degludec treatment arms., Week 26|Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no), Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment are presented., Week 26|Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no), Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment are presented., Week 26|Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero, Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF., Week 26|Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero, Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) and change from baseline in body weight below or equal to zero after 26 weeks are presented. Missing values are imputed by LOCF., Week 26|Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes, 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 PG 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. Number of participants who achieved ADA HbA1c target (HbA1c \<7.0%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF., Week 26|Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes, 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 PG 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. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment and without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment are presented. Missing values are imputed by LOCF., Week 26|Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero., 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 PG 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. Number of participants who achieved ADA HbA1c target (HbA1c \< 7.0%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF., Week 26|Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero., 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 PG 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. Number of participants who achieved IDF HbA1c target (HbA1c ≤ 6.5%) (yes/no) after 26 weeks of treatment without severe or BG confirmed hypoglycaemic episodes during the last 12 weeks of treatment and with change from baseline in body weight below or equal to zero are presented. Missing values are imputed by LOCF., Week 26|Change in Fasting Plasma Glucose (FPG), Change from baseline (week 0) in FPG after 26 weeks of treatment is presented., Week 0, week 26|Change in Waist Circumferance, Change from baseline (week 0) in waist circumferance after 26 weeks of treatment is presented., Week 0, week 26|9-point SMPG Profile, Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). 9-point SMPG values at 26 weeks of treatment are presented., Week 26|Change in Mean of 9-point SMPG Profile, Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, 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 Mean Post-prandial Plasma Glucose (PG) Increments, Participants measured their PG levels using blood glucose meters at 9 time points (before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before dinner, 90 minutes after the start of dinner, at bedtime, at 4 am, before breakfast the following day). Post-prandial SMPG increments from before meal to 90 minutes after for breakfast, lunch and dinner were calculated. The mean increment over all meals was derived as the mean of all available meal increments. Change from baseline (week 0) in post-prandial SMPG increments for all meals after 26 weeks of treatment is presented., Week 0, week 26|Change in Fasting C-peptide - Ratio to Baseline, 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 Human Insulin - Ratio to Baseline, Change in fasting human 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, 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, Change in HOMA-B (measured in %) 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, 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 High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline, 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, 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, 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 Triglycerides - Ratio to Baseline., 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 Acid - Ratio to Baseline, Change in fasting free fatty acid (measured in mmol/L) from baseline (week 0) to week 26 is presented as ratio to baseline., Week 0, week 26|Number of Treatment-emergent Adverse Events (TEAE), A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. The observed rates of adverse events (AEs) per patient years of exposure (PYE) (number of AEs divided by PYE multiplied by 100) after 26 weeks are presented., Weeks 0-26|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes., Severe or BG confirmed hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG 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. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented., Weeks 0-26|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes., Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG 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. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented., Weeks 0-26|Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the ADA classification (requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG 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. Hypoglycaemic episodes were defined as nocturnal if the time of the onset was between 00:01 and 05.59 both inclusive. The number of episodes are represented as rates. The observed rates of episodes per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented., Weeks 0-26|Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition, A hypoglycaemic episode was 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 days after the last day on trial product. The number of episodes are represented as rates. The observed rates of episodes (according to the ADA definition) per PYE (number of episodes divided by PYE multiplied by 100) after 26 weeks of treatment are presented., Weeks 0-26|Change in Physical Examination, 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 screening (week -2) and week 26 per each category is presented., Week -2, week 26|Eye Examination, Dilated fundoscopy or fundus photography was performed by the investigator at screening (week -2) and week 26. The results of the examination were interpreted for each eye (left and right) and are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at screening (week -2) and week 26 is presented., Week -2, Week 26|Change in Electrocardiogram (ECG), Electrocardiogram was assessed by the investigator as normal, abnormal NCS and abnormal CS. Number of participants at screening (week -2) and at week 26 is presented., Week -2, week 26|Change in Pulse, Change in pulse from baseline (week 0) after 26 weeks of treatment is presented, Week 0, week 26|Change in Blood Pressure (Systolic and Diastolic Blood Pressure), Change in blood pressure (systolic and diastolic blood pressure) from baseline (week 0) after 26 weeks of treatment is presented, Week 0, week 26|Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum, Change in alkaline phosphatase, ALT, AST, creatine kinase, amylase, lipase, creatine kinase serum from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Biochemistry Parameters (Albumin Serum, Total Protein), Change in total protein, albumin serum from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum, Change in calcium serum (total), calcium corrected serum, potassium serum, sodium serum, urea serum from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum, Change in total bilirubin serum, creatinine serum from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haematological Parameter: Erythrocytes Blood, Change in erythrocyte blood from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haematological Parameter: Haematocrits, Change in haematocrits from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haemotological Parameter- Eosinophils, Change in eosinophils from baseline after 26 weeks of treatment is presented., Week 0, week 26|Change in Haematological Parameter - Neutrophils, Change in neutrophils from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haematological Parameter: Basophils, Change in basophils from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haemotological Parameter- Monocytes, Change in monocytes from baseline (week 0) after 26 weeks of treatment is presented, Week 0, week 26|Change in Haematological Parameter - Lymphocytes, Change in lymphocytes from baseline (week 0) after 26 weeks of treatment is presented, Week 0, week 26|Change in Haematology: Haemoglobin Blood, Change in haemoglobin from baseline (week 0) after 26 weeks of treatment is presented., Week 0, week 26|Change in Haematologcal Parameter: Leukocytes, Change in leukocytes from baseline (week 0) after 26 weeks of treatment, Week 0, week 26|Change in Haematological Parameter: Thrombocytes, Change in thrombocytes from baseline (week 0) after 26 weeks of treatment, Week 0, week 26|Change in Calcitonin, Calcitonin levels were measured and were categorised as low, normal or high in relation to reference range (8.31- 14.3 picogram/milliliter \[pg/mL\]). Number of participants in each category at baseline (week 0) and week 26 are presented., Week 0, week 26|Urinalysis (Protein, Glucose, Erythrocytes and Ketones), The urinalysis assessment was the measurements of protein, glucose, erythrocytes and ketones in urine at baseline (week 0) and week 26 and categorised as negative, trace and positive. Number of participants in each category at week 0 and week 26 is presented., Week 0, week 26|Occurence of Anti-insulin Degludec Specific Antibodies, This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of anti-insulin degludec specific antibodies. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T)., Week 27|Occurence of Antibodies Cross-reacting to Human Insulin, This outcome measure is only applicable for the insulin degludec/liraglutide arm and insulin degludec arm. Serum samples were analysed for the presence of cross-reacting antibodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T)., Week 27|Occurence of Total Insulin Antibodies, This outcome measure is only applicable for the Insulin degludec/liraglutide arm and Insulin degludec arm. Serum samples were analysed for the presence of antobodies to human insulin. Results at week 27 are presented as percentage of bound radioactive-labelled insulin (B) /total radioactive-labelled insulin added to the samples (T)., Week 27|Occurence of Anti-liraglutide Antibodies, This outcome measure is applicable for the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of anti-liraglutide antibodies. Number of participants who were assessed for anti-liraglutide antibodies at week 27 are presented., Week 27|Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1), This outcome measure is applicable to the Insulin degludec/liraglutide arm and the liraglutide arm. Serum samples were analysed for the presence of cross-reacting antibodies to native GLP-1. Number of participants who measured with anti-liraglutide antibodies cross reacting native GLP-1 at week 27 are presented., Week 27|Occurence of Neutralising Liraglutide Antibodies, This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Neutralising antibodies were assessed when the corresponding anti-Liraglutide antibody were positive at week 27. Number of participants who measured with neutralising liraglutide antibodies at week 27 are presented., Week 27|Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1, This outcome measure is only applicable for the Insulin degludec/liraglutide arm and liraglutide arm. Cross reacting antibodies were assessed when anti-liraglutide antibody was positive. Number of participants who measured with neutralising liraglutide antibodies cross-reacting to native GLP-1 at week 27 are presented., Week 27|Serum Concentrations of Insulin Degludec, This outcome measure is applicable for Insulin degludec and Insulin degludec/liraglutide arms. Serum samples from the Insulin degludec/liraglutide and Insulin degludec arms were assayed using population PK analysis. The maximum serum concentrations (Cmax) are summarised for the two arms., Week 0, week 26|Plasma Concentration of Liraglutide, This outcome measure is for Insulin degludec/liraglutide and liraglutide arms. Serum samples from the Insulin degludec/liraglutide and liraglutide arms were assayed using population PK analysis. The Cmax are summarised for the two arms., Week 0, week 26
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| Locations: |
Novo Nordisk Investigational Site, Hefei, Anhui, 230061, China|Novo Nordisk Investigational Site, Beijing, Beijing, 100071, China|Novo Nordisk Investigational Site, Beijing, Beijing, 101200, China|Novo Nordisk Investigational Site, ChongQing, Chongqing, 404000, China|Novo Nordisk Investigational Site, Fuzhou, Fujian, 350001, China|Novo Nordisk Investigational Site, Fuzhou, Fujian, 350025, China|Novo Nordisk Investigational Site, Guangzhou, Guangdong, 510080, China|Novo Nordisk Investigational Site, Guangzhou, Guangdong, 510120, China|Novo Nordisk Investigational Site, Guangzhou, Guangdong, 510515, China|Novo Nordisk Investigational Site, Cangzhou, Hebei, 061000, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050000, China|Novo Nordisk Investigational Site, Shijiazhuang, Hebei, 050051, China|Novo Nordisk Investigational Site, Changzhou, Jiangsu, 213003, China|Novo Nordisk Investigational Site, Huai'an, Jiangsu, 223002, China|Novo Nordisk Investigational Site, Huai'an, Jiangsu, 223300, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210011, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210012, China|Novo Nordisk Investigational Site, Nanjing, Jiangsu, 210029, China|Novo Nordisk Investigational Site, Zhenjiang, Jiangsu, 212001, China|Novo Nordisk Investigational Site, Nanchang, Jiangxi, 330006, China|Novo Nordisk Investigational Site, Changchun, Jilin, 130021, China|Novo Nordisk Investigational Site, Dalian, Liaoning, 116011, China|Novo Nordisk Investigational Site, Yinchuan, Ningxia, 750004, China|Novo Nordisk Investigational Site, Xi'an, Shaanxi, 710061, China|Novo Nordisk Investigational Site, Jinan, Shandong, 250013, China|Novo Nordisk Investigational Site, Pudong New District, Shanghai, 201200, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200025, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200040, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200072, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200080, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200123, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200240, China|Novo Nordisk Investigational Site, Shanghai, Shanghai, 200336, China|Novo Nordisk Investigational Site, Tianjin, Tianjin, 300052, China|Novo Nordisk Investigational Site, Kunming, Yunnan, 650101, China|Novo Nordisk Investigational Site, Fuzhou, 350005, China
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