| Outcome Measures: |
Primary: Change in HbA1c (Glycosylated Haemoglobin) - FAS, Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS)., Week 0, week 20|Change in HbA1c (Glycosylated Haemoglobin) - PP, Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set., Week 0, week 20 | Secondary: Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values), Estimated mean change from baseline in FPG after 20 Weeks of treatment, Week 0, week 20|Number of Treatment Emergent Hypoglycaemic Episodes, A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to week 20|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score, From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state., Week 0|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score, From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state., Week 4|Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score, From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state., Week 20
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| Locations: |
Novo Nordisk Investigational Site, Capital Federal, 1405, Argentina|Novo Nordisk Investigational Site, Capital Federal, C1056ABJ, Argentina|Novo Nordisk Investigational Site, Chacabuco, B6740ELF, Argentina|Novo Nordisk Investigational Site, Cordoba, 5000, Argentina|Novo Nordisk Investigational Site, Córdoba, X5006IKK, Argentina|Novo Nordisk Investigational Site, Beijing, Beijing, 100034, China|Novo Nordisk Investigational Site, ChongQing, Chongqing, 404000, China|Novo Nordisk Investigational Site, Lanzhou, Gansu, 730000, China|Novo Nordisk Investigational Site, Zhengzhou, Henan, 450052, China|Novo Nordisk Investigational Site, Dalian, Liaoning, 116033, China|Novo Nordisk Investigational Site, Tianjin, 300211, China|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380 015, India|Novo Nordisk Investigational Site, Belgaum, Karnataka, 590001, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400007, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600028, India|Novo Nordisk Investigational Site, Coimbatore, Tamil Nadu, 641018, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, New Delhi, 110085, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India|Novo Nordisk Investigational Site, Bialystok, 15-404, Poland|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Lodz, 90-242, Poland|Novo Nordisk Investigational Site, Lubin, 59-300, Poland|Novo Nordisk Investigational Site, Ruda Slaska, 41-709, Poland|Novo Nordisk Investigational Site, Sopot, 81-756, Poland|Novo Nordisk Investigational Site, Warszawa, 00-911, Poland|Novo Nordisk Investigational Site, Wroclaw, 50-127, Poland|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Centelles (Barcelona), 08540, Spain|Novo Nordisk Investigational Site, La Roca del Vallés (Barcelona), 08430, Spain|Novo Nordisk Investigational Site, Málaga, 29006, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07014, Spain|Novo Nordisk Investigational Site, Valencia, 46014, Spain|Novo Nordisk Investigational Site, Vic (Barcelona), 08500, Spain|Novo Nordisk Investigational Site, Doncaster, DN9 2HY, United Kingdom|Novo Nordisk Investigational Site, Ipswich, IP4 5PD, United Kingdom|Novo Nordisk Investigational Site, Manchester, M41 5SL, United Kingdom|Novo Nordisk Investigational Site, Northwood, HA6 2RN, United Kingdom|Novo Nordisk Investigational Site, Reading, RG7 3SQ, United Kingdom|Novo Nordisk Investigational Site, Scunthorpe, DN15 6HX, United Kingdom|Novo Nordisk Investigational Site, Wirral, Merseyside, CH63 4JY, United Kingdom
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