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Clinical Trial Details

Trial ID: L3950
Source ID: NCT02098395
Associated Drug: Liraglutide
Title: The Efficacy and Safety of Liraglutide Adjunct to Insulin Treatment in Type 1 Diabetes
Acronym: ADJUNCT TWO™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02098395/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: liraglutide|DRUG: liraglutide|DRUG: liraglutide|DRUG: placebo|DRUG: placebo|DRUG: placebo
Outcome Measures: Primary: Change From Baseline in Glycosylated Haemoglobin (HbA1c), Change from baseline in glycosylated haemoglobin (HbA1c), after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data., Week 0, Week 26 | Secondary: Change From Baseline in Body Weight, Change from baseline body weight, after 26 weeks of treatment. Full analysis set (FAS = 831) included all randomised subjects who had received at least one dose and had any post-randomisation data., Week 0, Week 26|Number of Treatment-emergent Symptomatic Hypoglycaemic Episodes, Number of treatment-emergent symptomatic hypoglycaemic episodes during 26 weeks of treatment. Symptomatic hypoglycaemic episodes were defined as episodes that were severe according to the American Diabetes Association (ADA) classification or a self-measured plasma glucose (SMPG) value of \<3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification is defined as an episode that required assistance of another person to actively administer carbohydrate, glucagon or take other corrective actions., Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 835
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-05
Completion Date: 2015-04
Results First Posted: 2016-06-03
Last Update Posted: 2017-02-09
Locations: Novo Nordisk Investigational Site, Phoenix, Arizona, 85032, United States|Novo Nordisk Investigational Site, Little Rock, Arkansas, 72205, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, 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, Ventura, California, 93003, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Aurora, Colorado, 80045, United States|Novo Nordisk Investigational Site, Golden, Colorado, 80401, United States|Novo Nordisk Investigational Site, Maitland, Florida, 32751, 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, Champaign, Illinois, 61821, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Skokie, Illinois, 60077, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Minneapolis, Minnesota, 55416, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Billings, Montana, 59101, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Albany, New York, 12206, United States|Novo Nordisk Investigational Site, Jamaica, New York, 11432-1121, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Chapel Hill, North Carolina, 27517, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Fargo, North Dakota, 58103, United States|Novo Nordisk Investigational Site, Bristol, Tennessee, 37620-7352, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Austin, Texas, 78758, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, Ogden, Utah, 84405, United States|Novo Nordisk Investigational Site, Bennington, Vermont, 05201, United States|Novo Nordisk Investigational Site, Federal Way, Washington, 98003, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Seattle, Washington, 98195, United States|Novo Nordisk Investigational Site, Graz, 8036, Austria|Novo Nordisk Investigational Site, Wien, 1130, Austria|Novo Nordisk Investigational Site, Aalst, 9300, Belgium|Novo Nordisk Investigational Site, Bonheiden, 2820, Belgium|Novo Nordisk Investigational Site, Boussu, 7300, Belgium|Novo Nordisk Investigational Site, Brussels, 1090, Belgium|Novo Nordisk Investigational Site, Bruxelles, 1200, Belgium|Novo Nordisk Investigational Site, Edegem, 2650, Belgium|Novo Nordisk Investigational Site, Kortrijk, 8500, Belgium|Novo Nordisk Investigational Site, Leuven, 3000, Belgium|Novo Nordisk Investigational Site, Mouscron, 7700, Belgium|Novo Nordisk Investigational Site, Sint-Niklaas, 9100, Belgium|Novo Nordisk Investigational Site, Blagoevgrad, 2700, Bulgaria|Novo Nordisk Investigational Site, Pazardzhik, 4401, Bulgaria|Novo Nordisk Investigational Site, Plovdiv, 4002, Bulgaria|Novo Nordisk Investigational Site, Razgrad, 7200, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Calgary, Alberta, T2V 4J2, Canada|Novo Nordisk Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Novo Nordisk Investigational Site, Cornwall, Ontario, K6H 4M4, Canada|Novo Nordisk Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|Novo Nordisk Investigational Site, Mississauga, Ontario, L5M 2V8, Canada|Novo Nordisk Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Novo Nordisk Investigational Site, Laval, Quebec, H7T 2P5, Canada|Novo Nordisk Investigational Site, Montreal, Quebec, H2X 0A9, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1H 5N4, Canada|Novo Nordisk Investigational Site, Hvidovre, 2650, Denmark|Novo Nordisk Investigational Site, København, 2400, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Helsinki, 00250, Finland|Novo Nordisk Investigational Site, Joensuu, 80200, Finland|Novo Nordisk Investigational Site, Jyväskylä, 40620, Finland|Novo Nordisk Investigational Site, Oulu, FI-90220, Finland|Novo Nordisk Investigational Site, Pori, 28500, Finland|Novo Nordisk Investigational Site, Turku, FI-20520, Finland|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, MARSEILLE cedex 08, 13285, France|Novo Nordisk Investigational Site, MONTPELLIER cedex 5, 34295, France|Novo Nordisk Investigational Site, Paris, 75014, France|Novo Nordisk Investigational Site, Pierre-Bénite, 69495, France|Novo Nordisk Investigational Site, Reims, 51100, France|Novo Nordisk Investigational Site, Strasbourg, 67098, France|Novo Nordisk Investigational Site, TOULOUSE cedex, 31054, France|Novo Nordisk Investigational Site, Trinité - La Martinique, 97235, France|Novo Nordisk Investigational Site, Bergamo, 24127, Italy|Novo Nordisk Investigational Site, Catanzaro, 88100, Italy|Novo Nordisk Investigational Site, Firenze, 50141, Italy|Novo Nordisk Investigational Site, Palermo, 90127, Italy|Novo Nordisk Investigational Site, Roma, 00133, Italy|Novo Nordisk Investigational Site, Roma, 00168, Italy|Novo Nordisk Investigational Site, sesto san giovanni (MI), 20099, Italy|Novo Nordisk Investigational Site, Siena, 53100, Italy|Novo Nordisk Investigational Site, Amersfoort, 3813 TZ, Netherlands|Novo Nordisk Investigational Site, Apeldoorn, 7334 DZ, Netherlands|Novo Nordisk Investigational Site, Den Bosch, 5223GZ, Netherlands|Novo Nordisk Investigational Site, Den Haag, 2597 AX, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5631 BM, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3584 CX, Netherlands|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2198, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7925, South Africa|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Gijón, 33206, Spain|Novo Nordisk Investigational Site, Segovia, 40002, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Sevilla, 41014, Spain|Novo Nordisk Investigational Site, Linköping, 582 16, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Stockholm, 112 81, Sweden|Novo Nordisk Investigational Site, Umeå, 901 85, Sweden|Novo Nordisk Investigational Site, Ängelholm, 262 91, Sweden|Novo Nordisk Investigational Site, Örebro, 701 85, Sweden
URL: https://clinicaltrials.gov/show/NCT02098395

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress