Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6476
Source ID: NCT01388361
Associated Drug: Insulin Degludec
Title: Comparison of the Efficacy and Safety of Two Intensification Strategies in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin and Metformin
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01388361/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin aspart|DRUG: liraglutide
Outcome Measures: Primary: Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin), Values for change in HbA1c from baseline to 26 weeks of treatment period., week 0, week 26 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Values for change in FPG in mmol/L from baseline to week 26 of randomised period., week 0, week 26|Change From Baseline in Body Weight, Corresponds to the values of change in body weight in kilograms from baseline to week 26., week 0, week 26|Number of Severe and Minor Treatment Emergent Hypoglycaemic Episodes, Corresponds to number of treatment emergent hypoglycaemic events from onset on or after the first day of exposure to investigational product and no later than 7 days after last exposure to investigational product. Confirmed hypoglycaemia was defined as the pool of severe hypoglycaemic episodes and minor episodes with a plasma glucose (PG) value \< 3.1 mmol/L (56 mg/dL)., Onset on or after the first day of exposure to investigational product for 26 weeks of treatment period and no later than 7 days after last exposure to investigational product.
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 413
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2012-07
Results First Posted: 2015-11-26
Last Update Posted: 2017-03-06
Locations: Novo Nordisk Investigational Site, Concord, California, 94520-1926, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, National City, California, 91950, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262, United States|Novo Nordisk Investigational Site, Santa Monica, California, 90404, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Tarzana, California, 91356-3551, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Melbourne, Florida, 32901, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Palm Harbor, Florida, 34684, United States|Novo Nordisk Investigational Site, West Palm Beach, Florida, 33401, United States|Novo Nordisk Investigational Site, Decatur, Georgia, 30033, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, 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, North East, Maryland, 21901, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08755-8050, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Asheboro, North Carolina, 27203, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Melrose Park, Pennsylvania, 19027, United States|Novo Nordisk Investigational Site, Upper St. Clair, Pennsylvania, 15241, United States|Novo Nordisk Investigational Site, East Providence, Rhode Island, 02914, United States|Novo Nordisk Investigational Site, Columbia, South Carolina, 29203, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Humboldt, Tennessee, 38343, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76014, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76113, United States|Novo Nordisk Investigational Site, Irving, Texas, 75061-2210, United States|Novo Nordisk Investigational Site, Lubbock, Texas, 79423, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78215, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Feldkirch, 6807, Austria|Novo Nordisk Investigational Site, Wien, 1030, Austria|Novo Nordisk Investigational Site, Wien, 1090, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Wolfsberg, 9400, Austria|Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Gent, 9000, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Liège, 4000, Belgium|Novo Nordisk Investigational Site, Edmonton, Alberta, T5J 3N4, Canada|Novo Nordisk Investigational Site, Coquitlam, British Columbia, V3K 3P4, Canada|Novo Nordisk Investigational Site, Vancouver, British Columbia, V5Z 1M9, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Novo Nordisk Investigational Site, St. John's, Newfoundland and Labrador, A1A 3R5, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, B3K 0A4, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Ottawa, Ontario, K1K 4L2, Canada|Novo Nordisk Investigational Site, Ottawa, Ontario, K1N 6N5, Canada|Novo Nordisk Investigational Site, Scarborough, Ontario, M1E 5E9, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5C 2T2, Canada|Novo Nordisk Investigational Site, St-Marc-des-Carrières, Quebec, G0A 4B0, Canada|Novo Nordisk Investigational Site, St. Romuald, Quebec, G6W 5M6, Canada|Novo Nordisk Investigational Site, Quebec, G1V 4G2, Canada|Novo Nordisk Investigational Site, Brno, 65691, Czech Republic|Novo Nordisk Investigational Site, Hradec Kralove, 500 05, Czech Republic|Novo Nordisk Investigational Site, Plzen, 304 60, Czech Republic|Novo Nordisk Investigational Site, Prague 4, 140 21, Czech Republic|Novo Nordisk Investigational Site, Esbjerg, 6700, Denmark|Novo Nordisk Investigational Site, Hillerød, 3400, Denmark|Novo Nordisk Investigational Site, Holbæk, 4300, Denmark|Novo Nordisk Investigational Site, København S, 2300, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Silkeborg, 8600, Denmark|Novo Nordisk Investigational Site, Helsinki, 00260, Finland|Novo Nordisk Investigational Site, Joensuu, 80100, Finland|Novo Nordisk Investigational Site, Kerava, FI-04200, Finland|Novo Nordisk Investigational Site, Lohja, 08100, Finland|Novo Nordisk Investigational Site, Oulu, 90100, Finland|Novo Nordisk Investigational Site, Tampere, 33210, Finland|Novo Nordisk Investigational Site, Montigny-les-Metz, 57950, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Nimes, 30006, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Berlin, 13055, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Essen, 45329, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 22391, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Neuwied, 56564, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Rehburg-Loccum, 31547, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, Speyer, 67346, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Bekkestua, 1357, Norway|Novo Nordisk Investigational Site, Elverum, 2408, Norway|Novo Nordisk Investigational Site, Hamar, 2318, Norway|Novo Nordisk Investigational Site, Kongsvinger, 2212, Norway|Novo Nordisk Investigational Site, Oslo, 0407, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Trondheim, NO-7030, Norway|Novo Nordisk Investigational Site, Ålesund, 6003, Norway|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Kragujevac, 34000, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia|Novo Nordisk Investigational Site, Novi Sad, 21000, Serbia|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Antequera, 29200, Spain|Novo Nordisk Investigational Site, El Ferrol, 15405, Spain|Novo Nordisk Investigational Site, Inca, 07300, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07014, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain
URL: https://clinicaltrials.gov/show/NCT01388361

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress