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Clinical Trial Details

Trial ID: L6320
Source ID: NCT01045707
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01045707/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin glargine
Outcome Measures: Primary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment, Change from baseline in HbA1c after 26 weeks of treatment., Week 0, Week 26|Extension Trial (Primary Endpoint): 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L., Week 0 to Week 53 + 7 days follow up|Extension Trial (Primary Endpoint): 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 are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m., Week 0 to Week 53 + 7 days follow up|Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs), Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect, Week 0 to Week 53 + 7 days follow up | Secondary: Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment, Change from baseline in HbA1c after 52 weeks of treatment., Week 0, Week 53|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Mean of SMPG at 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: 530
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: 2015-11-20
Last Update Posted: 2016-12-08
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35233, United States|Novo Nordisk Investigational Site, Vestavia, Alabama, 35209, United States|Novo Nordisk Investigational Site, Concord, California, 94520-1926, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33169, United States|Novo Nordisk Investigational Site, North Miami, Florida, 33161, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96813, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70006-2930, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70119, United States|Novo Nordisk Investigational Site, Detroit, Michigan, 48235, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48085-5524, United States|Novo Nordisk Investigational Site, Springfield, Missouri, 65807, United States|Novo Nordisk Investigational Site, St. Charles, Missouri, 63303, United States|Novo Nordisk Investigational Site, Brooklyn, New York, 11203, United States|Novo Nordisk Investigational Site, Smithtown, New York, 11787, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Wilson, North Carolina, 27893, United States|Novo Nordisk Investigational Site, Tulsa, Oklahoma, 74104, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97220, United States|Novo Nordisk Investigational Site, Portland, Oregon, 97239, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75235, United States|Novo Nordisk Investigational Site, Lubbock, Texas, 79423, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78240, United States|Novo Nordisk Investigational Site, Tomball, Texas, 77375, United States|Novo Nordisk Investigational Site, St. George, Utah, 84790, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Ebreichsdorf, 2483, Austria|Novo Nordisk Investigational Site, Feldbach, 8330, Austria|Novo Nordisk Investigational Site, Innsbruck, 6020, Austria|Novo Nordisk Investigational Site, Salzburg, 5010, Austria|Novo Nordisk Investigational Site, Wien, 1030, Austria|Novo Nordisk Investigational Site, Wien, 1060, Austria|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400053, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Trichy, Tamil Nadu, 620018, India|Novo Nordisk Investigational Site, Bangalore, 560038, India|Novo Nordisk Investigational Site, Kerala, 682026, India|Novo Nordisk Investigational Site, Patna, 800020, India|Novo Nordisk Investigational Site, Pucheon, 424-017, Korea, Republic of|Novo Nordisk Investigational Site, Pusan, 602-739, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 08308, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 137-701, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 158-710, Korea, Republic of|Novo Nordisk Investigational Site, Krakow, 31-261, Poland|Novo Nordisk Investigational Site, Lodz, 90-003, Poland|Novo Nordisk Investigational Site, Lodz, 93-338, Poland|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Pruszkow, 05-800, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Bayamon, 00961, Puerto Rico|Novo Nordisk Investigational Site, Arkhangelsk, 163045, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Nizhniy Novgorod, 603126, Russian Federation|Novo Nordisk Investigational Site, Orenburg, 460040, Russian Federation|Novo Nordisk Investigational Site, Samara, 443067, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410053, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410710, Russian Federation|Novo Nordisk Investigational Site, Smolensk, 214019, Russian Federation|Novo Nordisk Investigational Site, Stavropol, 355017, Russian Federation|Novo Nordisk Investigational Site, Yaroslavl, 150003, Russian Federation|Novo Nordisk Investigational Site, Barcelona, 08035, Spain|Novo Nordisk Investigational Site, Málaga, 29006, Spain|Novo Nordisk Investigational Site, Mérida, 06800, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07198, Spain|Novo Nordisk Investigational Site, Partida de Bacarot, 03114, Spain|Novo Nordisk Investigational Site, Pozuelo de Alarcon, 28223, Spain|Novo Nordisk Investigational Site, San Sebastián de los Reyes, 28700, Spain|Novo Nordisk Investigational Site, Santiago de Compostela, 15706, Spain|Novo Nordisk Investigational Site, Sevilla, 41009, Spain|Novo Nordisk Investigational Site, Valencia, 46014, Spain|Novo Nordisk Investigational Site, Valladolid, 47005, Spain|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Istanbul, 34390, Turkey|Novo Nordisk Investigational Site, Istanbul, 34400, Turkey|Novo Nordisk Investigational Site, Istanbul, 34760, Turkey|Novo Nordisk Investigational Site, Istanbul, Turkey
URL: https://clinicaltrials.gov/show/NCT01045707

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress