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Clinical Trial Details

Trial ID: L5760
Source ID: NCT01814137
Associated Drug: Insulin Degludec/Insulin Aspart
Title: A Randomised Trial Comparing Efficacy and Safety After Intensification With Either Insulin Aspart Once Daily as add-on or Changing to Basal Bolus Treatment With Insulin Degludec and Insulin Aspart in Subjects With Type 2 Diabetes Previously Treated With Insulin Degludec/Insulin Aspart Twice Daily
Acronym: BOOST®
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01814137/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin degludec|DRUG: insulin aspart|DRUG: insulin aspart
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c after 26 weeks of treatment, Week 0, week 26 | Secondary: Incidence of Treatment Emergent Adverse Events (TEAEs), A treatment emergent adverse event was defined as an event that had onset date on or after the first day of trial product administration, and no later than 7 days after the last dose of the trial product., During 26 weeks of treatment|Number of Treatment Emergent Hypoglycaemic Episodes, Confirmed hypoglycaemic episodes were defined as episodes that are either: * severe (i.e., an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) or * biochemically confirmed by a PG value of \<3.1 mmol/L (56 mg/dL), with or without symptoms consistent with hypoglycaemia., During 26 weeks of treatment|Number of Treatment Emergent Nocturnal (00:01-05:59) Confirmed Hypoglycaemic Episodes, Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 00:01 and 05:59 hours inclusive. Confirmed hypoglycaemic episodes were defined as severe hypoglycaemic episodes and/or a measured PG below 3.1 mmol/L (below 56 mg/dL)., During 26 weeks of treatment|Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in FPG after 26 weeks of treatment. FPG was analysed on blood samples from fasting subjects which were analysed centrally., Week 0, week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2013-03
Completion Date: 2014-03
Results First Posted: 2015-11-13
Last Update Posted: 2017-03-21
Locations: Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85020, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Avon, Illinois, 46123, United States|Novo Nordisk Investigational Site, Crystal Lake, Illinois, 60012, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Myrtle Beach, South Carolina, 29572, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76132, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Tacoma, Washington, 98405, United States|Novo Nordisk Investigational Site, Kenosha, Wisconsin, 53142, United States|Novo Nordisk Investigational Site, Algiers, 16000, Algeria|Novo Nordisk Investigational Site, Oran, 31000, Algeria|Novo Nordisk Investigational Site, Tizi Ouzou, 16015, Algeria|Novo Nordisk Investigational Site, Erdmannhausen, 71729, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Selangor, 46150, Malaysia|Novo Nordisk Investigational Site, Denizli, 20070, Turkey|Novo Nordisk Investigational Site, Gaziantep, 27070, Turkey|Novo Nordisk Investigational Site, Hatay, 31040, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey
URL: https://clinicaltrials.gov/show/NCT01814137

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress