| Outcome Measures: |
Primary: Change in HbA1c (%) - Week 26, Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation., Week 0, week 26 | Secondary: Change in HbA1c (%) - Week 38, Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation., Week 0, week 38|Responder (Yes/No) for HbA1c < 7%, Participants achieving (yes/no) HbA1c \<7% was evaluated 26 and 38 weeks after randomisation, respectively., Week 26 and week 38|Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia, Participants achieving (yes/no) HbA1c \<7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration., Week 26 and week 38|Change in FPG, Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively., Week 0, week 26, week 38|Change in Pre-breakfast SMPG (Used for Titration), Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation., Week 1, week 26, week 38|Change in Postprandial SMPG Increment (From 9-point Profile), Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit)., Week 0, week 26, week 38|Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product., Weeks 0-26, weeks 16-26, weeks 0-38|Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes, Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product., Weeks 0-26, weeks 16-26, weeks 0-38|Total Insulin Dose, Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively., Week 26 and week 38|Change in Body Weight, Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively., Week 0, week 26, week 38|Incidence of TEAEs, Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse event that had an onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE., Weeks 0-26, weeks 26-38, weeks 0-38
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| Locations: |
Novo Nordisk Investigational Site, Glendale, Arizona, 85306-4652, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85050, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Danbury, Connecticut, 06810, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33312, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33316, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34744, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, New York, New York, 10029, United States|Novo Nordisk Investigational Site, Westfield, New York, 14787, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Bartlett, Tennessee, 38133, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Knoxville, Tennessee, 37938, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37228, United States|Novo Nordisk Investigational Site, Austin, Texas, 78758, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78230, United States|Novo Nordisk Investigational Site, Chesapeake, Virginia, 23321, United States|Novo Nordisk Investigational Site, Midlothian, Virginia, 23114, United States|Novo Nordisk Investigational Site, Winchester, Virginia, 22601-3834, United States|Novo Nordisk Investigational Site, Constantine, 25000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Sidi Bel Abbes, 22000, Algeria|Novo Nordisk Investigational Site, Broumov, 550 01, Czechia|Novo Nordisk Investigational Site, Nachod, 547 01, Czechia|Novo Nordisk Investigational Site, Nachod, 54701, Czechia|Novo Nordisk Investigational Site, Prague 4, 140 21, Czechia|Novo Nordisk Investigational Site, Praha 4, 140 46, Czechia|Novo Nordisk Investigational Site, Trutnov, 541 01, Czechia|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500001, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500072, India|Novo Nordisk Investigational Site, Surat, Gujarat, 395002, India|Novo Nordisk Investigational Site, Kozhikode, Kerala, 673017, India|Novo Nordisk Investigational Site, Aurangabad, Maharashtra, 431005, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400058, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, 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, 110001, India|Novo Nordisk Investigational Site, Arkhangelsk, 163045, Russian Federation|Novo Nordisk Investigational Site, Cheboksary, 428009, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127486, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 191119, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195213, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 197762, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410039, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410053, Russian Federation|Novo Nordisk Investigational Site, Syktyvkar, 167981, Russian Federation|Novo Nordisk Investigational Site, Tumen, 625023, Russian Federation|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Belgrade, 11080, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia|Novo Nordisk Investigational Site, Adana, 01250, Turkey|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Ankara, 06500, Turkey|Novo Nordisk Investigational Site, Istanbul, 34098, Turkey|Novo Nordisk Investigational Site, Istanbul, 34303, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey|Novo Nordisk Investigational Site, Izmir, 35340, Turkey
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