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Clinical Trial Details

Trial ID: L2534
Source ID: NCT02420262
Associated Drug: Insulin Degludec/Liraglutide
Title: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02420262/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/liraglutide|DRUG: insulin glargine|DRUG: insulin aspart
Outcome Measures: Primary: Change in HbA1c (Glycosylated Haemoglobin), Change in HbA1c values after 26 weeks of treatment., Week 0, Week 26 | Secondary: Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes., Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of \<56 mg/dL (3.1 mmol/L), with symptoms consistent with hypoglycaemia., Weeks 0-26|Change in Body Weight, Change in body weight after 26 weeks of treatment., Week 0, Week 26|Responder for HbA1c Below 7.0%, Number of subjects with HbA1c below 7% after 26 weeks of treatment., After 26 weeks of treatment|Responder for HbA1c Below or Equal to 6.5 %, Number of subjects with HbA1c below 6.5% after 26 weeks of treatment., After 26 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 506
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2015-07-26
Completion Date: 2016-10-05
Results First Posted: 2017-12-07
Last Update Posted: 2018-03-29
Locations: Novo Nordisk Investigational Site, Tuscumbia, Alabama, 35674, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Bermuda Dunes, California, 92203, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Lincoln, California, 95648, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, 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, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Waterbury, Connecticut, 06708, United States|Novo Nordisk Investigational Site, Palm Harbor, Florida, 34684-3609, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Blackfoot, Idaho, 83221, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Natchitoches, Louisiana, 71457-5881, United States|Novo Nordisk Investigational Site, Shreveport, Louisiana, 71105, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89109, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Jackson Heights, New York, 11372, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Shelby, North Carolina, 28150, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43213, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19152, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Murrells Inlet, South Carolina, 29576, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77058, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77479, United States|Novo Nordisk Investigational Site, Midlothian, Virginia, 23114, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99208, United States|Novo Nordisk Investigational Site, Caba, C1440AAD, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1405, Argentina|Novo Nordisk Investigational Site, Córdoba, X5006IKK, Argentina|Novo Nordisk Investigational Site, Salta, 4400, Argentina|Novo Nordisk Investigational Site, Brno, 65691, Czechia|Novo Nordisk Investigational Site, Hradec Králové, 500 36, Czechia|Novo Nordisk Investigational Site, Olomouc, Lazce, 77900, Czechia|Novo Nordisk Investigational Site, Olomouc, 77900, Czechia|Novo Nordisk Investigational Site, Pardubice, 53002, Czechia|Novo Nordisk Investigational Site, Prostejov, 79601, Czechia|Novo Nordisk Investigational Site, Angers, 49000, France|Novo Nordisk Investigational Site, Bourgoin-jallieu, 38302, France|Novo Nordisk Investigational Site, Brest, 29609, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Coudray, 28630, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, MARSEILLE cedex 08, 13285, France|Novo Nordisk Investigational Site, Marseille, 13008, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Saint Priest en Jarez, 42270, France|Novo Nordisk Investigational Site, Strasbourg, 67098, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Athens, GR-11527, Greece|Novo Nordisk Investigational Site, Chalkida, Evia, GR-34100, Greece|Novo Nordisk Investigational Site, Ioannina, 45500, Greece|Novo Nordisk Investigational Site, Larissa, GR-41110, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54642, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57001, Greece|Novo Nordisk Investigational Site, Budapest, 1115, Hungary|Novo Nordisk Investigational Site, Gyula, H-5700, Hungary|Novo Nordisk Investigational Site, Szeged, H-6720, Hungary|Novo Nordisk Investigational Site, Szombathely, H-9700, Hungary|Novo Nordisk Investigational Site, Tatabánya, 2800, Hungary|Novo Nordisk Investigational Site, Haifa, 35152, Israel|Novo Nordisk Investigational Site, Holon, 58100, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Nahariya, 22100, Israel|Novo Nordisk Investigational Site, Rehovot, 76100, Israel|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44650, Mexico|Novo Nordisk Investigational Site, Mexico City, México, D.F., 03300, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20230, Mexico|Novo Nordisk Investigational Site, Durango, 34000, Mexico|Novo Nordisk Investigational Site, Kazan, 420073, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 191119, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194291, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199034, Russian Federation|Novo Nordisk Investigational Site, Volgograd, 400131, Russian Federation|Novo Nordisk Investigational Site, Bardejov, 08501, Slovakia|Novo Nordisk Investigational Site, Dolny Kubin, 02601, Slovakia|Novo Nordisk Investigational Site, Malacky, 90101, Slovakia|Novo Nordisk Investigational Site, Poprad, 05801, Slovakia|Novo Nordisk Investigational Site, Roznava, 04801, Slovakia|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Fuenlabrada - Madrid, 28942, Spain|Novo Nordisk Investigational Site, Pozuelo de Alarcon, 28223, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Valencia, 46026, Spain|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Ankara, 06110, Turkey|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Istanbul, 34303, Turkey|Novo Nordisk Investigational Site, Istanbul, 34371, Turkey
URL: https://clinicaltrials.gov/show/NCT02420262

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress