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Clinical Trial Details

Trial ID: L6125
Source ID: NCT02100475
Associated Drug: Insulin Degludec/Liraglutide
Title: A Trial Comparing Sequential Addition of Insulin Aspart Versus Further Dose Increase With Insulin Degludec/Liraglutide in Subjects With Type 2 Diabetes Mellitus, Previously Treated With Insulin Degludec/Liraglutide and Metformin and in Need of Further Intensification
Acronym: DUAL™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02100475/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/liraglutide|DRUG: insulin aspart
Outcome Measures: Primary: Change From Baseline in HbA1c (Glycosylated Haemoglobin), Change from baseline in HbA1c after 26 weeks of treatment., Week 0, week 26 | Secondary: Change From Baseline in Body Weight, Change from baseline in body weight after 26 weeks of treatment., Week 0, week 26|Number of Treatment-emergent Confirmed Hypoglycaemic Episodes, Treatment-emergent hypoglycaemic episodes: if the onset of the episode occurred on or after the first day of investigational medicinal product administration, and no later than 7 days after the last day on investigational medicinal product. Confirmed hypoglycaemia: subject unable to treat himself/herself and/or have a recorded plasma glucose \< 3.1 mmol/L (56 mg/dL)., Week 0 - 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 31
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-04
Completion Date: 2015-04
Results First Posted: 2017-01-20
Last Update Posted: 2017-01-20
Locations: Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Fort Lauderdale, Florida, 33316-2521, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Buenos Aires, B1704ETD, Argentina|Novo Nordisk Investigational Site, Capital Federal, C1056ABJ, Argentina|Novo Nordisk Investigational Site, Corrientes, 3400, Argentina|Novo Nordisk Investigational Site, Salta, 4400, Argentina|Novo Nordisk Investigational Site, Zarate, B2800DGH, Argentina|Novo Nordisk Investigational Site, Wollongong, New South Wales, 2500, Australia|Novo Nordisk Investigational Site, Herston, Queensland, 4029, Australia|Novo Nordisk Investigational Site, Ipswich, Queensland, 4305, Australia|Novo Nordisk Investigational Site, Robina, Queensland, 4226, Australia|Novo Nordisk Investigational Site, East Ringwood, Victoria, 3135, Australia|Novo Nordisk Investigational Site, Athens, GR-11527, 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, Eger, 3300, Hungary|Novo Nordisk Investigational Site, Gyor, 9024, Hungary|Novo Nordisk Investigational Site, Gyula, 5700, Hungary|Novo Nordisk Investigational Site, Miskolc, 3526, Hungary|Novo Nordisk Investigational Site, Pachuca, Hidalgo, 42084, Mexico|Novo Nordisk Investigational Site, Cuernavaca, Morelos, 62250, Mexico|Novo Nordisk Investigational Site, Mexico City, México, D.F., 03300, Mexico|Novo Nordisk Investigational Site, Monterrey, 64460, Mexico|Novo Nordisk Investigational Site, Kazan, 420073, Russian Federation|Novo Nordisk Investigational Site, Kirov, 610014, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 123448, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630117, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199034, Russian Federation|Novo Nordisk Investigational Site, St. Petersburg, 194354, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634034, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634041, 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, Kosice, 040 11, Slovakia|Novo Nordisk Investigational Site, Levice, 93401, Slovakia|Novo Nordisk Investigational Site, Poprad, 05801, Slovakia|Novo Nordisk Investigational Site, Povazska Bystrica, 01701, Slovakia|Novo Nordisk Investigational Site, Prievidza, 97101, Slovakia|Novo Nordisk Investigational Site, Trnava, 91701, Slovakia|Novo Nordisk Investigational Site, Velky Meder, 93201, Slovakia|Novo Nordisk Investigational Site, Midrand, Gauteng, 1685, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4450, South Africa|Novo Nordisk Investigational Site, Brits, North West, 0250, South Africa|Novo Nordisk Investigational Site, Alberton, 1449, South Africa|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Granada, 18012, Spain|Novo Nordisk Investigational Site, Palma de Mallorca, 07014, Spain|Novo Nordisk Investigational Site, Sevilla, 41003, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Valencia, 46026, Spain
URL: https://clinicaltrials.gov/show/NCT02100475

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress