| Outcome Measures: |
Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 16 weeks of treatment, Week 0, Week 16 | Secondary: Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Estimate of the overall mean of SMPG 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, before bedtime, at 4 am and before breakfast., Week 16|Rate of Major and Minor Hypoglycaemic Episodes, Observed 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 05:59 (included)., 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 -4) and at Week 16, Week -4, Week 16|Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT), Laboratory values at screening (Week -4) and at Week 16, Week -4, Week 16|Laboratory Safety Parameters (Biochemistry): Serum Creatinine, Laboratory values at screening (Week -4) and at Week 16, Week -4, Week 16|Vital Signs: Diastolic Blood Pressure (BP), Values at baseline (Week 0) and at Week 16, Week 0, Week 16|Vital Signs: Systolic Blood Pressure (BP), 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 -4), 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 -4, Week 8, Week 16
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| Locations: |
Novo Nordisk Investigational Site, Helsinki, 00260, Finland|Novo Nordisk Investigational Site, Kuopio, 70210, Finland|Novo Nordisk Investigational Site, Lahti, 15110, Finland|Novo Nordisk Investigational Site, Pori, FI-28100, Finland|Novo Nordisk Investigational Site, Bar-Le-Duc, 55000, France|Novo Nordisk Investigational Site, GRENOBLE cedex, 38043, France|Novo Nordisk Investigational Site, Hayange, 57700, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, NEVERS cedex, 58033, France|Novo Nordisk Investigational Site, Pointe à Pitre, 97159, France|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Pirna, 01796, Germany|Novo Nordisk Investigational Site, Riesa, 01587, Germany|Novo Nordisk Investigational Site, Saarbrücken, 66121, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Bydgoszcz, 85-822, Poland|Novo Nordisk Investigational Site, Gniewkowo, 88-140, Poland|Novo Nordisk Investigational Site, Nysa, 48-300, Poland|Novo Nordisk Investigational Site, Plock, 09-400, Poland|Novo Nordisk Investigational Site, Szczecin, 70-483, Poland|Novo Nordisk Investigational Site, Tychy, 43-100, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Wroclaw, 50-127, Poland|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Barcelona, 08035, Spain|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, Madrid, 28034, Spain|Novo Nordisk Investigational Site, San Juan, 03550, Spain
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