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Clinical Trial Details

Trial ID: L2757
Source ID: NCT01618162
Associated Drug: Insulin Degludec/Liraglutide
Title: The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
Acronym: DUAL™IV
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01618162/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/liraglutide|DRUG: placebo
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c), Change in HbA1c from baseline to 26 weeks., Week 0, Week 26 | Secondary: Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol), Percentage of subjects having HbA1c below 7% at week 26., Week 26|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol), Percentage of subjects having HbA1c below 6.5% at week 26, Week 26|Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline in FPG at week 26., Week 0, week 26|Change From Baseline in Body Weight, Change from baseline in body weight at week 26., Week 0, week 26|Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes, An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE)., After 26 weeks of treatment|Number of Adverse Events (AEs), An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE., After 26 weeks of treatment
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 435
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-08-29
Completion Date: 2013-10-23
Results First Posted: 2017-02-17
Last Update Posted: 2017-10-27
Locations: Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Garden Grove, California, 92844, United States|Novo Nordisk Investigational Site, La Jolla, California, 92037, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, San Mateo, California, 94401, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Melbourne, Florida, 32934, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Crestview Hills, Kentucky, 41017-3464, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Saint Charles, Missouri, 63303, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Lodi, New Jersey, 076444, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Tabor City, North Carolina, 28463, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45220-2213, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104-5020, United States|Novo Nordisk Investigational Site, Beaver, Pennsylvania, 15009, 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, Pelzer, South Carolina, 29669, United States|Novo Nordisk Investigational Site, Simpsonville, South Carolina, 29681, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37203, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75203, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Lukovit, 5770, Bulgaria|Novo Nordisk Investigational Site, Ruse, 7000, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1324, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1431, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Burnaby, British Columbia, V5G 1T4, Canada|Novo Nordisk Investigational Site, Surrey, British Columbia, V3S 2N6, Canada|Novo Nordisk Investigational Site, Victoria, British Columbia, V8V 3N7, Canada|Novo Nordisk Investigational Site, Cambridge, Ontario, N1R 7L6, Canada|Novo Nordisk Investigational Site, London, Ontario, N6G 2M1, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M4S 1Y2, Canada|Novo Nordisk Investigational Site, Mirabel, Quebec, J7J 2K8, Canada|Novo Nordisk Investigational Site, Pointe Claire, Quebec, H9R 4S3, Canada|Novo Nordisk Investigational Site, Sherbrooke, Quebec, J1G 5K2, Canada|Novo Nordisk Investigational Site, Quebec, G1N 4V3, Canada|Novo Nordisk Investigational Site, Esslingen, 73728, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Hohenmölsen, 06679, 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, Sulzbach-Rosenberg, 92237, Germany|Novo Nordisk Investigational Site, Guwahati, Assam, 781007, India|Novo Nordisk Investigational Site, Guwahati, Assam, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560043, India|Novo Nordisk Investigational Site, Belgaum, Karnataka, 590001, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411030, India|Novo Nordisk Investigational Site, Delhi, New Delhi, 110002, India|Novo Nordisk Investigational Site, Hyderabad, 600034, India|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, Petah-Tikva, 49100, Israel|Novo Nordisk Investigational Site, Tel Hashomer, 52621, Israel|Novo Nordisk Investigational Site, Tel-Aviv, 64239, Israel|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Ankara, 06110, Turkey|Novo Nordisk Investigational Site, Antalya, 07058, Turkey|Novo Nordisk Investigational Site, Gaziantep, 27070, Turkey|Novo Nordisk Investigational Site, Istanbul, 34752, Turkey|Novo Nordisk Investigational Site, Izmir, 35100, Turkey
URL: https://clinicaltrials.gov/show/NCT01618162

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress