| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 16 weeks of treatment, Week 0, Week 16 | Secondary: Change in Fasting Plasma Glucose (FPG), Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment, Week 0, Week 16|Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast., Week 16|Rate of Major and Minor Hypoglycaemic Episodes, Rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to Week 16 + 5 days follow up|Rate of Nocturnal Major and Minor Hypoglycaemic Episodes, Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded)., Week 0 to Week 16 + 5 days follow up|Rate of Treatment Emergent Adverse Events (AEs), Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect., Week 0 to Week 16 + 5 days follow up|Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT), Laboratory values at screening (Week -1) and at Week 16, Week -1, Week 16|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT), Laboratory values at screening (Week -1) and at Week 16, Week -1, Week 16|Laboratory Safety Parameters (Biochemistry): Serum Creatinine, Laboratory values at screening (Week -1) and at Week 16, Week -1, Week 16|Vital Signs: Diastolic BP (Blood Pressure), Values at baseline (Week 0) and at Week 16, Week 0, Week 16|Vital Signs: Systolic BP (Blood Pressure), Values at baseline (Week 0) and at Week 16, Week 0, Week 16|Vital Signs: Pulse, Values at baseline (Week 0) and at Week 16, Week 0, Week 16|Physical Examination, Physical examination was performed at screening (week -1), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed., Week -1, Week 8, Week 16
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| Locations: |
Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Des Moines, Iowa, 50314, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Wollongong, New South Wales, 2500, Australia|Novo Nordisk Investigational Site, Keswick, South Australia, 5035, Australia|Novo Nordisk Investigational Site, East Ringwood, Victoria, 3135, Australia|Novo Nordisk Investigational Site, Geelong, 3220, Australia|Novo Nordisk Investigational Site, Miranda, 2228, Australia|Novo Nordisk Investigational Site, Aschaffenburg, 63739, Germany|Novo Nordisk Investigational Site, Bad Kreuznach, 55545, Germany|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Bergen, 5021, Norway|Novo Nordisk Investigational Site, Bergen, NO-5012, Norway|Novo Nordisk Investigational Site, Elverum, 2408, Norway|Novo Nordisk Investigational Site, Kristiansand S, 4604, Norway|Novo Nordisk Investigational Site, Oslo, 0586, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Alingsås, 441 83, Sweden|Novo Nordisk Investigational Site, Karlstad, 651 85, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Stockholm, 112 81, Sweden|Novo Nordisk Investigational Site, Stockholm, 182 88, Sweden|Novo Nordisk Investigational Site, Umeå, 901 85, Sweden
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