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Clinical Trial Details

Trial ID: L6464
Source ID: NCT00972283
Associated Drug: Insulin Degludec
Title: Comparison of NN1250 With Insulin Glargine Plus Insulin Aspart With/Without Metformin and With/Without Pioglitazone in Type 2 Diabetes
Acronym: BEGIN™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00972283/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin glargine|DRUG: insulin aspart
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 78 + 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 78 + 7 days follow up|Rate of Treatment Emergent Adverse Events (AEs), Corresponds to rate of AEs per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious adverse event (SAE): 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 78 + 7 days follow up | Secondary: Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 78 Weeks of Treatment, Change from baseline in HbA1c after 78 weeks of treatment, Week 0, Week 78|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 78, Mean of the SMPG at 78 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, before breakfast., Week 78|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|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: 1006
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-09-01
Completion Date: 2010-10-28
Results First Posted: 2015-11-13
Last Update Posted: 2017-04-06
Locations: Novo Nordisk Investigational Site, Alexander City, Alabama, 35010, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35209, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Peoria, Arizona, 85381, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Huntington Beach, California, 92648, United States|Novo Nordisk Investigational Site, Los Gatos, California, 95032, United States|Novo Nordisk Investigational Site, Salinas, California, 93901, 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, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Milford, Connecticut, 06460, United States|Novo Nordisk Investigational Site, Norwalk, Connecticut, 06851, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06712, United States|Novo Nordisk Investigational Site, Washington, District of Columbia, 20060, United States|Novo Nordisk Investigational Site, Gainesville, Florida, 32610, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Lake Mary, Florida, 32746, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32804, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, 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, Fort Valley, Georgia, 31030-5008, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Nampa, Idaho, 83686-6011, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46217, United States|Novo Nordisk Investigational Site, New Albany, Indiana, 47150, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70006-2930, 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, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Eagan, Minnesota, 55123, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63104, United States|Novo Nordisk Investigational Site, Lincoln, Nebraska, 68521, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89117, 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, Charlotte, North Carolina, 28209, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43203, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43606-2920, United States|Novo Nordisk Investigational Site, Danville, Pennsylvania, 17822, United States|Novo Nordisk Investigational Site, Kingston, Pennsylvania, 18704, United States|Novo Nordisk Investigational Site, Melrose Park, Pennsylvania, 19027, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Wilkes Barre, Pennsylvania, 18711, United States|Novo Nordisk Investigational Site, Charleston, South Carolina, 29455, 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, 37404, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78412, 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, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23233, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Dimitrovgrad, 6400, Bulgaria|Novo Nordisk Investigational Site, Ruse, 7000, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1233, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Stara Zagora, 6000, Bulgaria|Novo Nordisk Investigational Site, Varna, 9010, Bulgaria|Novo Nordisk Investigational Site, Dresden, 01219, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Frankfurt, 60388, Germany|Novo Nordisk Investigational Site, Hamburg, 22587, Germany|Novo Nordisk Investigational Site, Ludwigshafen, 67059, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Wangen, 88239, Germany|Novo Nordisk Investigational Site, Warburg, 34414, Germany|Novo Nordisk Investigational Site, Shatin, New Territories, Hong Kong|Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 8, Ireland|Novo Nordisk Investigational Site, Dublin, Ireland|Novo Nordisk Investigational Site, Bari, 70124, Italy|Novo Nordisk Investigational Site, Bergamo, 24127, Italy|Novo Nordisk Investigational Site, Catania, 95124, Italy|Novo Nordisk Investigational Site, Chieti Scalo, 66100, Italy|Novo Nordisk Investigational Site, Firenze, 50141, Italy|Novo Nordisk Investigational Site, Foggia, 71100, Italy|Novo Nordisk Investigational Site, Gazi, 98124, Italy|Novo Nordisk Investigational Site, Messina, 98123, Italy|Novo Nordisk Investigational Site, Milano, 20132, Italy|Novo Nordisk Investigational Site, Perugia, 06126, Italy|Novo Nordisk Investigational Site, Pisa, 56100, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy|Novo Nordisk Investigational Site, Torino, 10126, Italy|Novo Nordisk Investigational Site, Baia Mare, Maramures, 430123, Romania|Novo Nordisk Investigational Site, Bucharest, 011234, Romania|Novo Nordisk Investigational Site, Constanta, 900591, Romania|Novo Nordisk Investigational Site, Suceava, 720237, Romania|Novo Nordisk Investigational Site, Timisoara, 300736, Romania|Novo Nordisk Investigational Site, Arkhangelsk, 163001, Russian Federation|Novo Nordisk Investigational Site, Barnaul, 656045, Russian Federation|Novo Nordisk Investigational Site, Krasnoyarsk, 660022, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 125367, Russian Federation|Novo Nordisk Investigational Site, Perm, 614990, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Yaroslavl, 150003, Russian Federation|Novo Nordisk Investigational Site, Bratislava, 82102, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 05, Slovakia|Novo Nordisk Investigational Site, Lucenec, 984 01, Slovakia|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0181, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4450, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, South Africa|Novo Nordisk Investigational Site, Bloemfontein, 9301, South Africa|Novo Nordisk Investigational Site, Alcorcón, 28922, Spain|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Barcelona, 08035, Spain|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, Hospitalet de Llobregat, 08907, Spain|Novo Nordisk Investigational Site, La Coruña, 15006, Spain|Novo Nordisk Investigational Site, Madrid, 28040, Spain|Novo Nordisk Investigational Site, Mostoles - Madrid -, 28935, Spain|Novo Nordisk Investigational Site, Sabadell, 08208, Spain|Novo Nordisk Investigational Site, San Juan, 03550, Spain|Novo Nordisk Investigational Site, Valencia, 46026, Spain|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34098, Turkey|Novo Nordisk Investigational Site, Istanbul, 34390, Turkey|Novo Nordisk Investigational Site, Mersin, 33070, Turkey
URL: https://clinicaltrials.gov/show/NCT00972283

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress