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Clinical Trial Details

Trial ID: L4623
Source ID: NCT01836523
Associated Drug: Liraglutide
Title: The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes
Acronym: ADJUNCT ONE™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01836523/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: liraglutide|DRUG: placebo|DRUG: liraglutide|DRUG: placebo|DRUG: liraglutide|DRUG: placebo
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c at week 52. Missing values were handled by using a mixed model for repeated measurements (MMRM)., Week 0, week 52|Change From Baseline in Body Weight, Change from baseline in body weight at week 52. Missing values were handled by using a MMRM., Week 0, week 52|Change From Baseline in Total Daily Insulin Dose, Change from baseline in total daily insulin dose at week 52. Change from baseline was represented in terms of ratio to baseline for insulin dose i.e. Total daily insulin dose at week 52/total daily insulin dose at baseline. Missing values were handled by using a MMRM., Week 0, week 52 | Secondary: Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes, This is a confirmatory secondary endpoint. Symptomatic hypoglycaemic episodes were defined as: 1) Severe according to the American Diabetes Association (ADA) classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. OR 2) Self-monitoring of plasma glucose value of \<3.1 mmol/L, with symptoms consistent with hypoglycaemia. A treatment emergent episode is defined as an episode with onset date (or increase in severity) on or after first day of exposure to randomised treatment and up to last dose + 7 days., Weeks 0-52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1398
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-11
Completion Date: 2015-06
Results First Posted: 2017-03-06
Last Update Posted: 2017-03-06
Locations: Novo Nordisk Investigational Site, Little Rock, Arkansas, 72205, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Huntington Beach, California, 92648, United States|Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Monterey, California, 93940, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80209, United States|Novo Nordisk Investigational Site, Ft. Lauderdale, Florida, 33312, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33619, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30308-2253, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30060, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Savannah, Georgia, 31405, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Iowa City, Iowa, 52242, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Metarie, Louisiana, 70006, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21229, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Springfield, Missouri, 65807, United States|Novo Nordisk Investigational Site, St. Charles, Missouri, 63303, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63110-1020, United States|Novo Nordisk Investigational Site, St. Peters, Missouri, 63376, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Mineola, New York, 11501, United States|Novo Nordisk Investigational Site, New York, New York, 10029, United States|Novo Nordisk Investigational Site, New York, New York, 10032, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Mentor, Ohio, 44060, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15224-2215, United States|Novo Nordisk Investigational Site, Upper Darby, Pennsylvania, 19082, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Myrtle Beach, South Carolina, 29572, United States|Novo Nordisk Investigational Site, Summerville, South Carolina, 29485, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404-1192, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Memphis, Tennessee, 38119-3821, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37212, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, 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, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84102, United States|Novo Nordisk Investigational Site, Bennington, Vermont, 05201, United States|Novo Nordisk Investigational Site, Norfolk, Virginia, 23510, United States|Novo Nordisk Investigational Site, Federal Way, Washington, 98003, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99208, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53226, United States|Novo Nordisk Investigational Site, Caba, C1118AAT, Argentina|Novo Nordisk Investigational Site, Caba, C1440AAD, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1405, Argentina|Novo Nordisk Investigational Site, Córdoba, X5016KEH, Argentina|Novo Nordisk Investigational Site, Mendoza, 5500, Argentina|Novo Nordisk Investigational Site, Morón, B1708IFF, Argentina|Novo Nordisk Investigational Site, Broadmeadow, New South Wales, 2292, Australia|Novo Nordisk Investigational Site, Elizabeth Vale, South Australia, 5112, Australia|Novo Nordisk Investigational Site, Keswick, South Australia, 5035, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, 3004, Australia|Novo Nordisk Investigational Site, Parkville, Victoria, 3050, Australia|Novo Nordisk Investigational Site, Arlon, 6700, Belgium|Novo Nordisk Investigational Site, Edegem, 2650, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Liège, 4000, Belgium|Novo Nordisk Investigational Site, Edmonton, Alberta, T6G 2E1, Canada|Novo Nordisk Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Novo Nordisk Investigational Site, Barrie, Ontario, L4M 7G1, Canada|Novo Nordisk Investigational Site, Cambridge, Ontario, N1R 7L6, Canada|Novo Nordisk Investigational Site, London, Ontario, N6A 4V2, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Oakville, Ontario, L6M 1M1, Canada|Novo Nordisk Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5C 2T2, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M5T 3L9, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H2W 1R7, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1G 5K2, Canada|Novo Nordisk Investigational Site, Quebec, G1V 4G2, Canada|Novo Nordisk Investigational Site, Quebec, G1V 4G5, Canada|Novo Nordisk Investigational Site, Helsinki, 00029, Finland|Novo Nordisk Investigational Site, Helsinki, 00250, Finland|Novo Nordisk Investigational Site, Pori, 28500, Finland|Novo Nordisk Investigational Site, Seinäjoki, 60220, Finland|Novo Nordisk Investigational Site, Seinäjoki, 60510, Finland|Novo Nordisk Investigational Site, Tampere, 33520, Finland|Novo Nordisk Investigational Site, Turku, FI-20520, Finland|Novo Nordisk Investigational Site, Besancon, 25030, France|Novo Nordisk Investigational Site, Brest, 29609, France|Novo Nordisk Investigational Site, Caen, 14033, France|Novo Nordisk Investigational Site, Corbeil Essonnes, 91106, France|Novo Nordisk Investigational Site, DIJON cedex, 21079, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Paris, 75877, France|Novo Nordisk Investigational Site, Pointe à Pitre, 97159, France|Novo Nordisk Investigational Site, Poitiers, 86000, France|Novo Nordisk Investigational Site, Saint Herblain, 44800, France|Novo Nordisk Investigational Site, Saint Priest en Jarez, 42270, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Eisenach, 99817, Germany|Novo Nordisk Investigational Site, Essen, 45219, Germany|Novo Nordisk Investigational Site, Hamburg, 21073, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, Germany|Novo Nordisk Investigational Site, Marburg, 35039, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Pohlheim, 35415, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Dublin 9, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 4, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Galway, Ireland|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Holon, 58100, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Jerusalem, 93106, Israel|Novo Nordisk Investigational Site, Petah Tikva, 49202, Israel|Novo Nordisk Investigational Site, Rishon Le Zion, 75650, Israel|Novo Nordisk Investigational Site, Amsterdam, 1105 AZ, Netherlands|Novo Nordisk Investigational Site, Den Haag, 2512 VA, Netherlands|Novo Nordisk Investigational Site, Hoogeveen, 7909 AA, Netherlands|Novo Nordisk Investigational Site, Leiden, 2333 ZA, Netherlands|Novo Nordisk Investigational Site, Nijmegen, 6525 GA, Netherlands|Novo Nordisk Investigational Site, Rotterdam, 3011 TA, Netherlands|Novo Nordisk Investigational Site, Venlo, 5912 BL, Netherlands|Novo Nordisk Investigational Site, Bergen, 5021, Norway|Novo Nordisk Investigational Site, Gjettum, 1346, Norway|Novo Nordisk Investigational Site, Hamar, 2318, Norway|Novo Nordisk Investigational Site, Kongsvinger, 2226, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Pulawy, 24-100, Poland|Novo Nordisk Investigational Site, Warszawa, 00-911, Poland|Novo Nordisk Investigational Site, Warszawa, 03-242, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Kazan, 420012, Russian Federation|Novo Nordisk Investigational Site, Kazan, 420073, Russian Federation|Novo Nordisk Investigational Site, Penza, 440026, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410012, Russian Federation|Novo Nordisk Investigational Site, Volgograd, 400138, Russian Federation|Novo Nordisk Investigational Site, Göteborg, 413 45, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Stockholm, 112 81, Sweden|Novo Nordisk Investigational Site, Stockholm, 141 86, Sweden|Novo Nordisk Investigational Site, Kharkov, 61058, Ukraine|Novo Nordisk Investigational Site, Kharkov, 61070, Ukraine|Novo Nordisk Investigational Site, Kiev, 04114, Ukraine|Novo Nordisk Investigational Site, Poltava, 36011, Ukraine|Novo Nordisk Investigational Site, Zhytomir, 10002, Ukraine|Novo Nordisk Investigational Site, Blackburn, BB2 3HH, United Kingdom|Novo Nordisk Investigational Site, Bristol, BS10 5NB, United Kingdom|Novo Nordisk Investigational Site, Durham, DH11 5TW, United Kingdom|Novo Nordisk Investigational Site, Edgbaston, Birmingham, B15 2TH, United Kingdom|Novo Nordisk Investigational Site, Edinburgh, EH4 2XU, United Kingdom|Novo Nordisk Investigational Site, Middlesbrough, TS4 3BW, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8BQ, United Kingdom|Novo Nordisk Investigational Site, Southall, UB1 3HW, United Kingdom|Novo Nordisk Investigational Site, St Helens, WA9 3DA, United Kingdom|Novo Nordisk Investigational Site, Stevenage, SG1 4AB, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01836523

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress