| Outcome Measures: |
Primary: HbA1c (Glycosylated Haemoglobin), HbA1C at week 4 and 16, Week 4 and Week 16 | Secondary: Fasting Plasma Glucose (FPG), FPG at week 4 and 16, Week 4 and Week 16|Change in Body Weight, Change from baseline in body weight after week 4 and after week 16, Week 0, Week 4, Week 16|Rate of Treatment Emergent Adverse Events (AEs), Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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, Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Rate of Confirmed Hypoglycaemic Episodes, Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L., Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)|Rate of Nocturnal Confirmed Hypoglycaemic Episodes, Rate of nocturnal confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes with a confirmed plasma glucose value of less than 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m., Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
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| Locations: |
Novo Nordisk Clinical Trial Call Center, Goodyear, Arizona, 85395, United States|Novo Nordisk Clinical Trial Call Center, Phoenix, Arizona, 85018, United States|Novo Nordisk Clinical Trial Call Center, Anaheim, California, 92801, United States|Novo Nordisk Clinical Trial Call Center, Chino, California, 91710, United States|Novo Nordisk Clinical Trial Call Center, Concord, California, 94520, United States|Novo Nordisk Clinical Trial Call Center, Fresno, California, 93720, United States|Novo Nordisk Clinical Trial Call Center, Greenbrae, California, 94904, United States|Novo Nordisk Clinical Trial Call Center, Palm Springs, California, 92262-6972, United States|Novo Nordisk Clinical Trial Call Center, Kissimmee, Florida, 34741, United States|Novo Nordisk Clinical Trial Call Center, Chicago, Illinois, 60616, United States|Novo Nordisk Clinical Trial Call Center, Metairie, Louisiana, 70002, United States|Novo Nordisk Clinical Trial Call Center, Metairie, Louisiana, 70006-2930, United States|Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska, 68114, United States|Novo Nordisk Clinical Trial Call Center, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Clinical Trial Call Center, Dover, New Hampshire, 03820, United States|Novo Nordisk Clinical Trial Call Center, Nashua, New Hampshire, 03063, United States|Novo Nordisk Clinical Trial Call Center, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Clinical Trial Call Center, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Clinical Trial Call Center, Albany, New York, 12206, United States|Novo Nordisk Clinical Trial Call Center, Charlotte, North Carolina, 28209, United States|Novo Nordisk Clinical Trial Call Center, Melrose Park, Pennsylvania, 19027, United States|Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania, 15224-2215, United States|Novo Nordisk Clinical Trial Call Center, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Clinical Trial Call Center, Kingsport, Tennessee, 37660, United States|Novo Nordisk Clinical Trial Call Center, Austin, Texas, 78731, United States|Novo Nordisk Clinical Trial Call Center, Fort Worth, Texas, 76113, United States|Novo Nordisk Clinical Trial Call Center, Olympia, Washington, 98502, United States
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