Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6761
Source ID: NCT01045447
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01045447/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin glargine
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 26 weeks of treatment., Week 0, Week 26 | Secondary: Mean of 9-point Self Measured Plasma Glucose Profile (SMPG), Mean of SMPG after 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast., Week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 465
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-01
Completion Date: 2010-10
Results First Posted: 2015-11-18
Last Update Posted: 2017-03-20
Locations: Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32804, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33603, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Des Moines, Iowa, 50314-2610, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21204, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48034, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48075, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75235, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Osijek, 31 000, Croatia|Novo Nordisk Investigational Site, Rijeka, 51000, Croatia|Novo Nordisk Investigational Site, Antibes, 06600, France|Novo Nordisk Investigational Site, Besancon, 25030, France|Novo Nordisk Investigational Site, DAX, 40107, France|Novo Nordisk Investigational Site, Paris, 75877, France|Novo Nordisk Investigational Site, PERPIGNAN cedex, 66046, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Sète, 34200, France|Novo Nordisk Investigational Site, Ahmedabad, Gujarat, 380 015, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560092, India|Novo Nordisk Investigational Site, Belgaum, Karnataka, 590001, India|Novo Nordisk Investigational Site, Mangalore, Karnataka, 575001, India|Novo Nordisk Investigational Site, Thiruvanathapuram, Kerala, 695010, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411 037, India|Novo Nordisk Investigational Site, Bhubaneswar, Orissa, 751019, India|Novo Nordisk Investigational Site, Kanpur, 208005, India|Novo Nordisk Investigational Site, Busan, 602-715, Korea, Republic of|Novo Nordisk Investigational Site, Daegu, 700-721, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 03080, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 134-727, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 135-239, Korea, Republic of|Novo Nordisk Investigational Site, Sungnam, 463-707, Korea, Republic of|Novo Nordisk Investigational Site, Gdansk, 80-858, Poland|Novo Nordisk Investigational Site, Tychy, 43-100, Poland|Novo Nordisk Investigational Site, Warszawa, 00-911, Poland|Novo Nordisk Investigational Site, Wroclaw, 50-127, Poland|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1818, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1827, South Africa|Novo Nordisk Investigational Site, Benoni, 1500, South Africa|Novo Nordisk Investigational Site, Dalby, 240 10, Sweden|Novo Nordisk Investigational Site, Göteborg, 417 17, Sweden|Novo Nordisk Investigational Site, Härnösand, 871 82, Sweden|Novo Nordisk Investigational Site, Stockholm, 171 76, Sweden|Novo Nordisk Investigational Site, Ängelholm, 262 91, Sweden|Novo Nordisk Investigational Site, Istanbul, 34098, Turkey|Novo Nordisk Investigational Site, Istanbul, 34400, Turkey|Novo Nordisk Investigational Site, Istanbul, 34662, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Istanbul, Turkey|Novo Nordisk Investigational Site, Kahramanmaras, 46000, Turkey
URL: https://clinicaltrials.gov/show/NCT01045447