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Clinical Trial Details

Trial ID: L6212
Source ID: NCT01365507
Associated Drug: Insulin Degludec/Insulin Aspart
Title: Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Acronym: BOOST™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01365507/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/insulin aspart
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 26 weeks of treatment., Week 0, week 26 | Secondary: Change in Fasting Plasma Glucose (FPG), Change from baseline in FPG after 26 weeks of treatment., Week 0, week 26|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 26 + 7 days follow up|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 nocturnal 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: 276
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-04
Results First Posted: 2015-11-20
Last Update Posted: 2017-03-17
Locations: Novo Nordisk Investigational Site, Concord, California, 94520-1926, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32209-6511, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Crestview Hills, Kentucky, 41017-3464, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, North East, Maryland, 21901, 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, Eagan, Minnesota, 55123, United States|Novo Nordisk Investigational Site, Smithtown, New York, 11787, United States|Novo Nordisk Investigational Site, Asheboro, North Carolina, 27203, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Houston, Texas, 77070, United States|Novo Nordisk Investigational Site, Lubbock, Texas, 79423, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Seoul, 08308, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 110-746, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 150-950, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 158-710, Korea, Republic of|Novo Nordisk Investigational Site, Suwon, 16247, Korea, Republic of|Novo Nordisk Investigational Site, Johor Bahru, 80100, Malaysia|Novo Nordisk Investigational Site, Kota Bharu, Kelantan, 16150, Malaysia|Novo Nordisk Investigational Site, Selangor, 46150, Malaysia|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44650, Mexico|Novo Nordisk Investigational Site, Monterrey, 64460, Mexico|Novo Nordisk Investigational Site, Bayamon, 00961, Puerto Rico|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Nakhon Ratchasima, 30000, Thailand|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey
URL: https://clinicaltrials.gov/show/NCT01365507

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress