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Clinical Trial Details

Trial ID: L7366
Source ID: NCT01570751
Associated Drug: Insulin Degludec
Title: A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01570751/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin degludec|DRUG: insulin glargine
Outcome Measures: Primary: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period, Values for change in HbA1c after each 16 weeks of treatment periods A and B., Week 0, week 16 of each treatment period. | Secondary: Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period, Changes in subjects quality of life and insulin device satisfaction were evaluated using the following PROs: the Short-Form 36 Health Survey version 2 (SF-36) and the Treatment Related Impact Measure-Diabetes Device (TRIM-DD). PRO total scores were measured from baseline to the end of each 16-week treatment period. Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively., Week 0, week 16 of each treatment period.|Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B, SF-36 and TRIM-DD total scores were measured at the end of treatment A (week 16) and 4 weeks into treatment B (week 20). Responses were measured on a scale of 0 to 100, where higher scores indicated a better quality of life and higher insulin device satisfaction on the SF-36 and TRIM-DD questionnaires, respectively., Week 16, week 20|Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period, Values of FPG in mmol/L from baseline to each 16 weeks of treatment periods., Week 0, week 16, week 32|Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B, Values of FPG in mmol/L from the end of treatment period A until after 4 weeks of treatment in treatment period B., Week 16, week 20|Number of Adverse Events (AEs), Number of treatment emergent adverse events (TEAEs) from week 0 to week 16 of the randomised treatment periods. A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment. TEAEs were attributed to the treatment given in the period in which the event occurred., From baseline to the end of each 16 week treatment period.
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 145
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-04
Completion Date: 2014-01
Results First Posted: 2015-11-18
Last Update Posted: 2017-03-07
Locations: Novo Nordisk Investigational Site, Mesa, Arizona, 85206, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Greenbrae, California, 94904, United States|Novo Nordisk Investigational Site, San Ramon, California, 94583, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Homestead, Florida, 33030, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33016, United States|Novo Nordisk Investigational Site, Miami, Florida, 33155, United States|Novo Nordisk Investigational Site, Miami, Florida, 33156, United States|Novo Nordisk Investigational Site, St. Petersburg, Florida, 33709, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Avon, Illinois, 46123, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60611, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40502, United States|Novo Nordisk Investigational Site, Madisonville, Kentucky, 42431, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Slidell, Louisiana, 70461-4231, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Worcester, Massachusetts, 01655, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48034-7661, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89106, 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, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, Greenville, North Carolina, 27834, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37212, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75218, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Kingsville, Texas, 78363-6322, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78207, 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, Tacoma, Washington, 98405, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT01570751

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress