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Clinical Trial Details

Trial ID: L3806
Source ID: NCT00982644
Associated Drug: Insulin Degludec
Title: Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00982644/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin glargine
Outcome Measures: Primary: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment, Change from baseline in HbA1c after 52 weeks of treatment, Week 0, Week 52|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 104 + 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 104 + 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 104 + 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 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 52 + 7 days follow up|Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment, Change from baseline in HbA1c after 104 weeks of treatment, Week 0, Week 104|Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52, Mean of 9-point SMPG at 52 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 52|Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104, Mean of 9-point SMPG at 104 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 104|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 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 52 + 7 days follow up
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1030
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-09
Completion Date: 2010-12
Results First Posted: 2015-11-13
Last Update Posted: 2017-02-09
Locations: Novo Nordisk Investigational Site, Bay Minette, Alabama, 36507-4198, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35209, United States|Novo Nordisk Investigational Site, Huntsville, Alabama, 35801, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|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, Long Beach, California, 90806, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Mission Hills, California, 91345, United States|Novo Nordisk Investigational Site, National City, California, 91950, United States|Novo Nordisk Investigational Site, North Hollywood, California, 91606, 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, San Mateo, California, 94401, 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, Norwalk, Connecticut, 06851, United States|Novo Nordisk Investigational Site, Boynton Beach, Florida, 33472, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32208, United States|Novo Nordisk Investigational Site, Melbourne, Florida, 32901, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Miami, Florida, 33169, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Orange Park, Florida, 32073, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32806, 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, Fort Valley, Georgia, 31030-5008, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46217, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, 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, Greenbelt, Maryland, 20770, United States|Novo Nordisk Investigational Site, North East, Maryland, 21901, United States|Novo Nordisk Investigational Site, Reisterstown, Maryland, 21136-2516, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Brockton, Massachusetts, 02301, United States|Novo Nordisk Investigational Site, North Dartmouth, Massachusetts, 02747, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63104, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89117, 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, Charlotte, North Carolina, 28209, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45255, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45406, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43606-2920, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Kingston, Pennsylvania, 18704, United States|Novo Nordisk Investigational Site, Langhorne, Pennsylvania, 19047, United States|Novo Nordisk Investigational Site, Melrose Park, Pennsylvania, 19027, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15241, United States|Novo Nordisk Investigational Site, West Reading, Pennsylvania, 19611, 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, Newberry, South Carolina, 29108-2249, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Harriman, Tennessee, 37748-8653, 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, Corpus Christi, Texas, 78404, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, El Paso, Texas, 79912, 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, 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, Richmond, Virginia, 23233, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99218, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Bregenz, A - 6900, Austria|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, Wien, A 1160, Austria|Novo Nordisk Investigational Site, Wolfsberg, 9400, Austria|Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Brussels, 1090, 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, 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, London, Ontario, N6G 2M1, 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, M4G 3E8, 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, 656 91, 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, Praha 5, 15006, 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, Belgrade, 11000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Kragujevac, 34000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Nis, 18000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Novi Sad, 21000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Le Grau-du-Roi, 30240, France|Novo Nordisk Investigational Site, Montigny-les-Metz, 57950, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Nantes, 44093, France|Novo Nordisk Investigational Site, Nimes, 30006, France|Novo Nordisk Investigational Site, Saint-denis de La Reunion, 97405, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Bad Harzburg, 38667, Germany|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Berlin, 13055, Germany|Novo Nordisk Investigational Site, Dormagen, 41539, 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, 21073, Germany|Novo Nordisk Investigational Site, Hamburg, 22391, Germany|Novo Nordisk Investigational Site, Hamburg, 22587, 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, Riesa, 01587, 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, Bayamon, 00961, Puerto Rico|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, Koper, SI-6000, Slovenia|Novo Nordisk Investigational Site, Ljubljana, 1525, Slovenia|Novo Nordisk Investigational Site, Novo mesto, 8000, Slovenia|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Alzira, 46600, Spain|Novo Nordisk Investigational Site, Antequera, 29200, Spain|Novo Nordisk Investigational Site, El Ferrol, 15405, Spain|Novo Nordisk Investigational Site, Gijón, 33206, Spain|Novo Nordisk Investigational Site, Inca, 07300, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07014, Spain|Novo Nordisk Investigational Site, Puerto del Rosario, 35600, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Valencia, 46015, Spain
URL: https://clinicaltrials.gov/show/NCT00982644

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress