| Outcome Measures: |
Primary: Number of Adverse events (AEs) at week 13, Count of events, week 13 (± 2 weeks)|Number of patients with AEs at week 13, Number of patients, week 13 (± 2 weeks)|Percentage of patients with AEs at week 13, Percentage of patients, week 13 (± 2 weeks)|Number of Adverse events (AEs) at week 26, Count of events, week 26 (± 2 weeks)|Number of patients with AEs at week 26, Number of patients, week 26 (± 2 weeks)|Percentage of patients with AEs at week 26, Percentage of patients, week 26 (± 2 weeks) | Secondary: Number of patients with Adverse Drug Reaction (ADR) at week 13, Number of patients, week 13 (± 2 weeks)|Percentage of Patients with ADR at week 13, Percentage of patients, week 13 (± 2 weeks)|Number of Patients with ADR at week 26, Number of patients, week 26 (± 2 weeks)|Percentage of Patients with ADR at week 26, Percentage of patients, week 26 (± 2 weeks)|Number of patients with Serious AE/ADR at week 13, Number of patients, week 13 (± 2 weeks)|Percentage of patients with Serious AE/ADR at week 13, Percentage of patients, week 13 (± 2 weeks)|Number of patients with Serious AE/ADR at week 26, Number of patients, week 26 (± 2 weeks)|Percentage of patients with Serious AE/ADR at week 26, Percentage of patients, week 26 (± 2 weeks)|Number of patients with unexpected ADR at week 13, Number of patients, week 13 (± 2 weeks)|Percentage of patients with unexpected ADR at week 13, Percentage of patients, week 13 (± 2 weeks)|Number of subjects with unexpected ADR at week 26, Number of subjects, week 26 (± 2 weeks)|Percentage of patients with unexpected ADR at week 26, Percentage of patients, week 26 (± 2 weeks)|Number of patients with Severe or Blood Glucose (BG) confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13, Number of patients, week 13 (± 2 weeks)|Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 13, Percentage of patients, week 13 (± 2 weeks)|Number of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26, Number of patients, week 26 (± 2 weeks)|Percentage of patients with Severe or BG confirmed hypoglycaemia (Plasma Glucose <56 mg/dl) at week 26, Percentage of patients, week 26 (± 2 weeks)|Change from baseline in body weight at week 13, Measured in kg, week 0, week 13 (± 2 weeks)|Change from baseline in body weight at week 26, Measured in kg, week 0, week 26 (± 2 weeks)|Insulin dose at week 13, Dose in Units, week 13 (± 2 weeks)|Insulin dose at week 26, Dose in Units, week 26 (± 2 weeks)|Change from baseline in HbA1c after 13 weeks of treatment, Measured in %, week 0, week 13 (± 2 weeks)|Change from baseline in HbA1c after 26 weeks of treatment, Measured in %, week 0, week 26 (± 2 weeks)|Percentage of patients achieving the target of HbA1c < 7.0% at 13 weeks of treatment, Percentage of patients, week 13 (± 2 weeks)|Percentage of patients achieving the target of HbA1c < 7.0% at 26 weeks of treatment, Percentage of patients, week 26 (± 2 weeks)|Change from baseline in Fasting Blood Glucose/Plasma Glucose (FBG/FPG) after 13 weeks treatment, Measured in mg/dl or other equivalent SI units, week 0, week 13 (± 2 weeks)|Change from baseline in FBG/FPG after 26 weeks treatment, Measured in mg/dl or other equivalent SI units, week 0, week 26 (± 2 weeks)|Changes from baseline in Post Prandial Blood/Plasma Glucose (PPBG/PPPG) after 13 weeks treatment, Measured in mg/dl or other equivalent SI units, week 0, week 13 (± 2 weeks)|Changes from baseline in PPBG/PPPG after 26 weeks treatment, Measured in mg/dl or other equivalent SI units, week 0, week 26 (± 2 weeks)
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| Locations: |
Novo Nordisk Investigational Site, Busan, 47392, Korea, Republic of|Novo Nordisk Investigational Site, Busan, 48108, Korea, Republic of|Novo Nordisk Investigational Site, Busan, 48575, Korea, Republic of|Novo Nordisk Investigational Site, Busan, 49267, Korea, Republic of|Novo Nordisk Investigational Site, Daegu, 42601, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 330-721, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 35015, Korea, Republic of|Novo Nordisk Investigational Site, Daejeon, 361-711, Korea, Republic of|Novo Nordisk Investigational Site, Gangwon-do, 26426, Korea, Republic of|Novo Nordisk Investigational Site, Goyang, 410-719, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-do, 10475, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-Do, 14068, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-do, 14584, Korea, Republic of|Novo Nordisk Investigational Site, Gyeonggi-do, 14754, Korea, Republic of|Novo Nordisk Investigational Site, Incheon, 22332, Korea, Republic of|Novo Nordisk Investigational Site, Jeonju, 54987, Korea, Republic of|Novo Nordisk Investigational Site, Jeonju, 561-712, Korea, Republic of|Novo Nordisk Investigational Site, Pusan, 602-739, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 01450, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 04401, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 04564, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 05355, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 07354, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 139-827, Korea, Republic of|Novo Nordisk Investigational Site, Suwon-si, Gyeonggi-do, 16247, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16499, Korea, Republic of|Novo Nordisk Investigational Site, Ulsan, 682-060, Korea, Republic of
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