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Clinical Trial Details

Trial ID: L4226
Source ID: NCT01676116
Associated Drug: Insulin Degludec/Liraglutide
Title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy
Acronym: DUAL™ III
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01676116/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec/liraglutide|DRUG: liraglutide|DRUG: exenatide
Outcome Measures: Primary: Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2), Week 0, week 26 | Secondary: Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol), Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment., Week 26|Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol), Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol)., Week 26|Change From Baseline in Body Weight, Mean change in body weight after 26 weeks of treatment., Week 0, week 26|Change From Baseline in Fasting Plasma Glucose (FPG), Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment., Week 0, week 26|Number of Severe or Minor Hypoglycaemic Episodes, Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose \<2.8 mmol/L (50 mg/dL) or PG \<3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value \<2.8 mmol/L (50 mg/dL) or PG value \<3.1 mmol/L (56 mg/dL)., After 26 weeks of treatment|Number of Adverse Events (AEs), Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment., After 26 weeks of treatment|Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D), The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here., Week 0, week 26|Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ)., Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range., Week 0, week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 438
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-08-29
Completion Date: 2014-03-11
Results First Posted: 2018-07-09
Last Update Posted: 2019-01-03
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35216, United States|Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Mesa, Arizona, 85206, United States|Novo Nordisk Investigational Site, Phoenix, Arizona, 85018, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, Fair Oaks, California, 95628, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, Lancaster, California, 93534, United States|Novo Nordisk Investigational Site, Lomita, California, 90717, United States|Novo Nordisk Investigational Site, Long Beach, California, 90806, 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, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Tarzana, California, 91356-3551, United States|Novo Nordisk Investigational Site, Van Nuys, California, 91405, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80910, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Fort Myers, Florida, 33912-4343, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32258, United States|Novo Nordisk Investigational Site, Miami Springs, Florida, 33166, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33155, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32806, United States|Novo Nordisk Investigational Site, Plant City, Florida, 33563, United States|Novo Nordisk Investigational Site, Winter Haven, Florida, 33880, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Arlington Heights, Illinois, 60004-2315, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49048, United States|Novo Nordisk Investigational Site, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Saint Charles, Missouri, 63303, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68124, United States|Novo Nordisk Investigational Site, Henderson, Nevada, 89052-2649, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89128, United States|Novo Nordisk Investigational Site, Reno, Nevada, 89502-0111, United States|Novo Nordisk Investigational Site, Nashua, New Hampshire, 03063, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, Flemington, New Jersey, 08822-5763, United States|Novo Nordisk Investigational Site, Hamilton, New Jersey, 08619, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Toms River, New Jersey, 08753-2975, United States|Novo Nordisk Investigational Site, Mineola, New York, 11501, United States|Novo Nordisk Investigational Site, North Massapequa, New York, 11758-1802, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Morehead City, North Carolina, 28557, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43214, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Pittsburgh, Pennsylvania, 15243, United States|Novo Nordisk Investigational Site, Myrtle Beach, South Carolina, 29572, United States|Novo Nordisk Investigational Site, Sumter, South Carolina, 29150-1900, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Jellico, Tennessee, 37762, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37212, United States|Novo Nordisk Investigational Site, Tullahoma, Tennessee, 37388, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76014, United States|Novo Nordisk Investigational Site, Austin, Texas, 78731, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75218, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Fort Worth, Texas, 76113, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Houston, Texas, 77095, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, Round Rock, Texas, 78681, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78215, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78249, United States|Novo Nordisk Investigational Site, Schertz, Texas, 78154, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Orem, Utah, 84058, United States|Novo Nordisk Investigational Site, Saint George, Utah, 84790, United States|Novo Nordisk Investigational Site, Salt Lake City, Utah, 84107, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Coffs Harbour, New South Wales, 2450, Australia|Novo Nordisk Investigational Site, Merewether, New South Wales, 2291, Australia|Novo Nordisk Investigational Site, Keswick, South Australia, 5035, Australia|Novo Nordisk Investigational Site, Box Hill, Victoria, 3128, Australia|Novo Nordisk Investigational Site, Melbourne, Victoria, 3004, Australia|Novo Nordisk Investigational Site, Antibes, 06600, France|Novo Nordisk Investigational Site, Boulogne Billancourt, 92100, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Montigny-les-Metz, 57950, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Nimes, 30006, France|Novo Nordisk Investigational Site, Sète, 34200, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Budapest, 1042, Hungary|Novo Nordisk Investigational Site, Debrecen, 4043, Hungary|Novo Nordisk Investigational Site, Nyíregyhaza, 4400, Hungary|Novo Nordisk Investigational Site, Székesfehérvár, 8000, Hungary|Novo Nordisk Investigational Site, Bratislava, 811 08, Slovakia|Novo Nordisk Investigational Site, Bratislava, 831 01, Slovakia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Kosice, 040 01, Slovakia|Novo Nordisk Investigational Site, Lucenec, 98401, Slovakia|Novo Nordisk Investigational Site, Nitra, 94 911, Slovakia|Novo Nordisk Investigational Site, Presov, 080 01, Slovakia
URL: https://clinicaltrials.gov/show/NCT01676116

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress