| Outcome Measures: |
Primary: Change in local laboratory measured glycosylated haemoglobin (HbA1c), Measured in %point, From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study visit or at discontunuation (-2 to +8 weeks at 26 weeks) | Secondary: Change in total insulin dose, Measured in units/day, From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|Change in basal insulin dose, Measured in units/day, From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|Change in prandial insulin dose, Measured in units/day, From baseline (the most recent dose prior to treatment initiation (week 0)) to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|Change in local laboratory measured fasting plasma glucose (FPG), Measured in mg/dL, From baseline (up to 12 weeks prior to treatment initiation (week 0)) to end of study (-2 to +8 weeks at 26 weeks)|The incidence of patient recollection of non-severe hypoglycaemic episodes, Measured in episodes/person-year, Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|The incidence of patient recollection of nocturnal non-severe hypoglycaemic episodes, Measured in episodes/person-year, Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg® and within 4 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|The incidence of patient recollection of overall severe hypoglycaemic episodes, Measured in episodes/person-year, Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|The incidence of patient recollection of nocturnal severe hypoglycaemic episodes, Measured in episodes/person-year, Pre- and post initiation of treatment with Ryzodeg®. Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg® and within 26 weeks prior to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks)|Change in selected patient reported outcomes: Diabetes Therapy Related Quality of Life (DTR-QoL), Score (on a scale from 0-100, where 100 is the highest health related quality of life (HRQoL)), From baseline to end of study visit or at discontinuation (-2 to +8 weeks at 26 weeks). Baseline defined as visit 1 (week 0)
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| Locations: |
Novo Nordisk Investigational Site, Arakawa-ku, Tokyo, 116-0012, Japan|Novo Nordisk Investigational Site, Chuo-ku, Tokyo, 103-0002, Japan|Novo Nordisk Investigational Site, Fukuoka-shi, Fukuoka, 819-0006, Japan|Novo Nordisk Investigational Site, Fukushima, 963-8851, Japan|Novo Nordisk Investigational Site, Higashiosaka-shi, Osaka, Japan|Novo Nordisk Investigational Site, Hokkaido, 062-0007, Japan|Novo Nordisk Investigational Site, Hosu-gun, Ishikawa, 927-0053, Japan|Novo Nordisk Investigational Site, Kanagawa, 235-0045, Japan|Novo Nordisk Investigational Site, Kanagawa, 247-0055, Japan|Novo Nordisk Investigational Site, Kawagoe-shi, Saitama, 350-0851, Japan|Novo Nordisk Investigational Site, Kawaguchi-shi, Saitama, 332-0012, Japan|Novo Nordisk Investigational Site, Kisarazu-shi, Chiba, 292-0038, Japan|Novo Nordisk Investigational Site, Kita-ku, Tokyo, 114-0001, Japan|Novo Nordisk Investigational Site, Nagano, 390-8621, Japan|Novo Nordisk Investigational Site, Saitama-shi, Saitama, 336-0963, Japan|Novo Nordisk Investigational Site, Sapporo-shi, Hokkaido, 060-0001, Japan|Novo Nordisk Investigational Site, Sendai-shi, Miyagi, 980-0021, Japan|Novo Nordisk Investigational Site, Shimotsuga-gun, Tochigi, 321-0204, Japan|Novo Nordisk Investigational Site, Shimotsuke-shi, Tochigi, 329-0433, Japan|Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo, 160-0023, Japan|Novo Nordisk Investigational Site, Shizuoka-city, Shizuoka, 420-8630, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, Shizuoka, 420-0923, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, Shizuoka, 424-0853, Japan|Novo Nordisk Investigational Site, Tochigi, 323-0022, Japan|Novo Nordisk Investigational Site, Tokyo, 113-8431, Japan|Novo Nordisk Investigational Site, Tokyo, 143-8541, Japan|Novo Nordisk Investigational Site, Tsuchiura-shi,Ibaraki, 300-0062, Japan|Novo Nordisk Investigational Site, Yaizu-shi, Shizuoka, 425-0022, Japan|Novo Nordisk Investigational Site, Yokohama-shi, Kanagawa, 223-0066, Japan
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