| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 16, Estimated mean change from baseline in HbA1c after 16 Weeks of treatment., Week 0, Week 16 | Secondary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 36, Estimated mean change from baseline in HbA1c after 36 Weeks of treatment, Week 0, Week 36|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 16, Estimated mean change from baseline in FPG after 16 Weeks of treatment., Week 0, Week 16|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 36, Estimated mean change from baseline in FPG after 36 Weeks of treatment., Week 0, Week 36|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 16, Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment., Week 0, Week 16|Change in Mean Plasma Glucose (PG) of 7-Point Profile From Baseline to Week 36, Estimated mean change from baseline in mean PG of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment., Week 0, Week 36|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 16, Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 16 Weeks of treatment., Week 0, Week 16|Change in Mean Prandial PG Increment of 7-Point Profile From Baseline to Week 36, Estimated mean change from baseline in mean prandial PG increment of 7-point profile (7-points were before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner and at bedtime) after 36 Weeks of treatment., Week 0, Week 36|Change in Body Weight From Baseline to Week 16, Estimated mean change in body weight after 16 Weeks of treatment, Week 0, Week 16|Change in Body Weight From Baseline to Week 36, Estimated mean change in body weight after 36 Weeks of treatment, Week 0, Week 36|Number of Adverse Events (AEs), An AE was defined as treatment emergent if the onset date was on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment., Week 0 to Week 36 (inclusive)|Number of Confirmed Hypoglycaemic Episodes, A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and until the last day on randomised treatment. Confirmed hypoglycaemic episode was defined as hypoglycaemic episodes categorised to severe and/or minor hypoglycaemic episodes. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded PG \< 3.1 mmol/L (56 mg/dL). Minor: PG \< 3.1 mmol/L (56 mg/dL)., Week 0 to week 36 (inclusive)
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| Locations: |
Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103 0002, Japan|Novo Nordisk Investigational Site, Ebina-shi, Kanagawa, 243 0401, Japan|Novo Nordisk Investigational Site, Ebina-shi, 243 0432, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582 0005, Japan|Novo Nordisk Investigational Site, Katsushika-ku, Tokyo, 125 0054, Japan|Novo Nordisk Investigational Site, Koriyama-shi, Fukushima, 963 8851, Japan|Novo Nordisk Investigational Site, Miyazaki-shi, 880 0034, Japan|Novo Nordisk Investigational Site, Naka-shi, Ibaraki, 311 0113, Japan|Novo Nordisk Investigational Site, Niigata-shi, Niigata, 950 1104, Japan|Novo Nordisk Investigational Site, Nishinomiya-shi, Hygo, 662 0971, Japan|Novo Nordisk Investigational Site, Oita-shi, 870 0039, Japan|Novo Nordisk Investigational Site, Okawa-shi, Fukuoka, 831 0016, Japan|Novo Nordisk Investigational Site, Osaka-shi, Osaka, 553 0003, Japan|Novo Nordisk Investigational Site, Ota-ku, Tokyo, 144 0035, Japan|Novo Nordisk Investigational Site, Oyama-shi, Tochigi, 323 0022, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060 0062, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 062 0007, Japan|Novo Nordisk Investigational Site, Sendai-shi, 980 0021, Japan|Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi, 329 0433, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, 424 0853, Japan|Novo Nordisk Investigational Site, Takatsuki-shi, Osaka, 569 1096, Japan|Novo Nordisk Investigational Site, Tokyo, 187 8510, Japan|Novo Nordisk Investigational Site, Yokohama-shi, 235 0045, Japan
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