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Clinical Trial Details

Trial ID: L1940
Source ID: NCT00978627
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Comparison of NN5401 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00978627/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: insulin degludec/insulin aspart|DRUG: insulin detemir|DRUG: insulin aspart|DRUG: insulin aspart
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 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 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 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 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 subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with 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 hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect., Week 0 to Week 53 + 7 days of follow up | Secondary: Main Trial (Secondary 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 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|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26, Overall mean of 9-point 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|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): 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|Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment, Change from baseline in FPG after 52 weeks of treatment., Week 0, Week 53
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 548
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-08
Completion Date: 2010-05
Results First Posted: 2015-11-20
Last Update Posted: 2017-03-20
Locations: Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Mission Hills, California, 91345, United States|Novo Nordisk Investigational Site, North Hollywood, California, 91606, United States|Novo Nordisk Investigational Site, Salinas, California, 93901, United States|Novo Nordisk Investigational Site, Valencia, California, 91355, United States|Novo Nordisk Investigational Site, Aurora, Colorado, 80045, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Miami, Florida, 33169, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Lawrenceville, Georgia, 30046, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Shawnee Mission, Kansas, 66204, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Eagan, Minnesota, 55123, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, St. Peters, Missouri, 63376, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68131, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78215, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78240, United States|Novo Nordisk Investigational Site, Seattle, Washington, 98105, United States|Novo Nordisk Investigational Site, Broadmeadow, New South Wales, 2292, Australia|Novo Nordisk Investigational Site, Camperdown, New South Wales, 2050, Australia|Novo Nordisk Investigational Site, Coffs Harbour, New South Wales, 2450, Australia|Novo Nordisk Investigational Site, Keswick, South Australia, 5035, Australia|Novo Nordisk Investigational Site, Box Hill, Victoria, 3128, Australia|Novo Nordisk Investigational Site, Fitzroy, 3065, Australia|Novo Nordisk Investigational Site, Geelong, 3220, Australia|Novo Nordisk Investigational Site, Aalborg, 9100, Denmark|Novo Nordisk Investigational Site, Gentofte, 2820, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Auxerre, 89000, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Nimes, 30006, France|Novo Nordisk Investigational Site, Pointe à Pitre, 97159, France|Novo Nordisk Investigational Site, Petah Tikva, 49202, Israel|Novo Nordisk Investigational Site, Rishon Le Zion, 75650, Israel|Novo Nordisk Investigational Site, Tel Hashomer, 52621, Israel|Novo Nordisk Investigational Site, Lodz, 91-738, Poland|Novo Nordisk Investigational Site, Lodz, 93-338, Poland|Novo Nordisk Investigational Site, Sopot, 81-756, Poland|Novo Nordisk Investigational Site, Szczecin, 70-376, Poland|Novo Nordisk Investigational Site, Warszawa, 02-507, Poland|Novo Nordisk Investigational Site, Warszawa, 02-692, Poland|Novo Nordisk Investigational Site, Bayamon, 00961, Puerto Rico|Novo Nordisk Investigational Site, Cluj Napoca, Cluj, 400006, Romania|Novo Nordisk Investigational Site, Brasov, 500365, Romania|Novo Nordisk Investigational Site, Bucharest, 020042, Romania|Novo Nordisk Investigational Site, Bucharest, 020475, Romania|Novo Nordisk Investigational Site, Buzau, 120203, Romania|Novo Nordisk Investigational Site, Iasi, 700547, Romania|Novo Nordisk Investigational Site, Oradea, 410169, Romania|Novo Nordisk Investigational Site, Sibiu, 550245, Romania|Novo Nordisk Investigational Site, Kemerovo, 650066, Russian Federation|Novo Nordisk Investigational Site, Kursk, 305035, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 125367, Russian Federation|Novo Nordisk Investigational Site, Penza, 440026, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195257, 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, Volgograd, 400138, Russian Federation|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH16 4SA, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE1 5WW, United Kingdom|Novo Nordisk Investigational Site, Liverpool, L7 8XP, United Kingdom|Novo Nordisk Investigational Site, Oxford, OX3 7LE, United Kingdom|Novo Nordisk Investigational Site, Salford, M6 8HD, United Kingdom|Novo Nordisk Investigational Site, Wirral, Merseyside, CH63 4JY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00978627

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress