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Clinical Trial Details

Trial ID: L6487
Source ID: NCT01364428
Associated Drug: Insulin Degludec
Title: Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01364428/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin degludec
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Change from baseline in HbA1c after 22 weeks of treatment, Week 0, Week 22 | Secondary: Change in Fasting Plasma Glucose (FPG), Change from baseline in FPG after 22 weeks of treatment., Week 0, Week 22|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 22 + 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 22 + 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 22 + 7 days follow up
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 373
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-06
Completion Date: 2012-01
Results First Posted: 2015-11-18
Last Update Posted: 2017-03-06
Locations: Novo Nordisk Investigational Site, Huntsville, Alabama, 35801, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85213, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85018, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, National City, California, 91950, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33603, United States|Novo Nordisk Investigational Site, West Palm Beach, Florida, 33401, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Springfield, Illinois, 62711, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453-2717, United States|Novo Nordisk Investigational Site, Detroit, Michigan, 48235, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, 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, Canton, Ohio, 44718, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Melrose Park, Pennsylvania, 19027, United States|Novo Nordisk Investigational Site, Brentwood, Tennessee, 37027, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Irving, Texas, 75061-2210, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States
URL: https://clinicaltrials.gov/show/NCT01364428

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress