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Clinical Trial Details

Trial ID: L2506
Source ID: NCT01009580
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01009580/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: biphasic insulin aspart 30
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|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. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to Week 26 + 7 days follow up|Rate of Nocturnal 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. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m., Week 0 to Week 26 + 7 days follow up
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 447
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-11-05
Completion Date: 2010-08-23
Results First Posted: 2015-11-20
Last Update Posted: 2018-12-19
Locations: Novo Nordisk Investigational Site, St Leonards, New South Wales, 2065, Australia|Novo Nordisk Investigational Site, Wollongong, New South Wales, 2500, Australia|Novo Nordisk Investigational Site, East Ringwood, Victoria, 3135, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, 3004, Australia|Novo Nordisk Investigational Site, Garran, 2605, Australia|Novo Nordisk Investigational Site, Gentofte, 2820, Denmark|Novo Nordisk Investigational Site, Hjørring, 9800, Denmark|Novo Nordisk Investigational Site, Horsens, 8700, Denmark|Novo Nordisk Investigational Site, Hvidovre, 2650, Denmark|Novo Nordisk Investigational Site, København, 2400, Denmark|Novo Nordisk Investigational Site, Svendborg, 5700, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Kuopio, 70210, Finland|Novo Nordisk Investigational Site, Lahti, 15110, Finland|Novo Nordisk Investigational Site, Oulu, 90100, Finland|Novo Nordisk Investigational Site, Pori, FI-28100, Finland|Novo Nordisk Investigational Site, Ylitornio, FI-95600, Finland|Novo Nordisk Investigational Site, Karnal, Haryana, 132001, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560034, India|Novo Nordisk Investigational Site, Trivandrum, Kerala, 695011, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 4000021, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600 013, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Kolkata, 700017, India|Novo Nordisk Investigational Site, Mumbai, 400016, India|Novo Nordisk Investigational Site, New Delhi, 110044, India|Novo Nordisk Investigational Site, Cheras, 56000, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Pulau Pinang, 10990, Malaysia|Novo Nordisk Investigational Site, Putrajaya, 62250, Malaysia|Novo Nordisk Investigational Site, Bialystok, 15-445, Poland|Novo Nordisk Investigational Site, Bydgoszcz, 85-822, Poland|Novo Nordisk Investigational Site, Gniewkowo, 88-140, Poland|Novo Nordisk Investigational Site, Plock, 09-400, Poland|Novo Nordisk Investigational Site, Rawa Mazowiecka, 96-200, Poland|Novo Nordisk Investigational Site, Warszawa, 01-809, Poland|Novo Nordisk Investigational Site, Falun, 791 82, Sweden|Novo Nordisk Investigational Site, Karlstad, 651 85, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Lund, 222 22, Sweden|Novo Nordisk Investigational Site, Malmö, 211 52, Sweden|Novo Nordisk Investigational Site, Stockholm, 118 83, Sweden|Novo Nordisk Investigational Site, Changhua, 500, Taiwan|Novo Nordisk Investigational Site, Chiayi City, 600, Taiwan|Novo Nordisk Investigational Site, Taipei, 231, Taiwan|Novo Nordisk Investigational Site, Bangkok, 10110, Thailand|Novo Nordisk Investigational Site, Bangkok, 10330, Thailand|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Chiang Mai, 50200, Thailand|Novo Nordisk Investigational Site, Istanbul, 34093, Turkey|Novo Nordisk Investigational Site, Istanbul, 34722, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Kocaeli, 41380, Turkey
URL: https://clinicaltrials.gov/show/NCT01009580

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress