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Clinical Trial Details

Trial ID: L5904
Source ID: NCT01232491
Associated Drug: Insulin Detemir
Title: Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes
Acronym: DIET™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01232491/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Insulin detemir|DIETARY_SUPPLEMENT: Dietary regimen
Outcome Measures: Primary: Change From Baseline in Body Weight, Estimated mean change from baseline in body weight after 26 weeks of treatment., Week 0, Week 26 | Secondary: Change From Baseline in Body Mass Index (BMI), Estimated mean change from baseline in BMI after 26 weeks of treatment., Week 0, Week 26|Change From Baseline in Glycosylated Haemoglobin (HbA1c), Estimated mean change from baseline in HbA1c after 26 weeks of treatment., Week 0, Week 26|Change From Baseline in Fasting Plasma Glucose (FPG), Estimated mean change from baseline in FPG after 26 weeks of treatment., Week 0, Week 26|Rate of Treatment Emergent Adverse Events (TEAEs), Corresponds to rate of adverse events (AEs) per 100 patient years of exposure. Mild AEs: no or transient symptoms, no interference with subject's daily activities. Moderate AEs: marked symptoms, moderate interference with subject's daily activities. Severe AEs: considerable interference with subject's daily activities, unacceptable. Serious AEs: AEs that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect., Week 0 to Week 26|Rate of All Treatment Emergent Hypoglycaemic Episodes, Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions., Week 0 to Week 26|Rate of Nocturnal Treatment Emergent Hypoglycaemic Episodes, Corresponds to rate of treatment emergent hypoglycaemic episodes per patient exposure year. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. A hypoglycaemic episode with time of onset between 00:01 and 05:59 a.m. (both included) was considered nocturnal. Severe, if assistance was required to actively administer carbohydrate, glucagons or other resuscitative actions., Week 0 to Week 26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 611
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2010-10-29
Completion Date: 2011-11-14
Results First Posted: 2012-12-11
Last Update Posted: 2017-05-01
Locations: Novo Nordisk Investigational Site, Birmingham, Alabama, 35233, United States|Novo Nordisk Investigational Site, Ozark, Alabama, 36360, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Burlingame, California, 94010, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Fullerton, California, 92835, United States|Novo Nordisk Investigational Site, Long Beach, California, 90806, United States|Novo Nordisk Investigational Site, Long Beach, California, 90807, United States|Novo Nordisk Investigational Site, Long Beach, California, 90822, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, National City, California, 91950, United States|Novo Nordisk Investigational Site, Redlands, California, 92374, United States|Novo Nordisk Investigational Site, Santa Ana, California, 92705, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Colorado Springs, Colorado, 80907, United States|Novo Nordisk Investigational Site, Norwalk, Connecticut, 06851, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33765, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Jupiter, Florida, 33458, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33027, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33028, United States|Novo Nordisk Investigational Site, Pembroke Pines, Florida, 33029, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30342, United States|Novo Nordisk Investigational Site, Perry, Georgia, 31069, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Oympiafields, Illinois, 60641, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47714, United States|Novo Nordisk Investigational Site, Shawnee Mission, Kansas, 66204, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Portland, Maine, 04101, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Brockton, Massachusetts, 02301, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Southfield, Michigan, 48034, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, New York, New York, 10025, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Durham, North Carolina, 27710, United States|Novo Nordisk Investigational Site, Raleigh, North Carolina, 27609, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45406, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73104-5020, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Jenkintown, Pennsylvania, 19046, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Anderson, South Carolina, 29621, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Rapid City, South Dakota, 57701, 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, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Nashville, Tennessee, 37212, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Odessa, Texas, 79761, United States|Novo Nordisk Investigational Site, Plano, Texas, 75075, United States|Novo Nordisk Investigational Site, St. George, Utah, 84790, United States|Novo Nordisk Investigational Site, Norfolk, Virginia, 23502, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23249, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23294, United States|Novo Nordisk Investigational Site, Winchester, Virginia, 22601, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99208, United States|Novo Nordisk Investigational Site, Martinsburg, West Virginia, 25401, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Caba, C1419AHN, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1429, Argentina|Novo Nordisk Investigational Site, Córdoba, 5000, Argentina|Novo Nordisk Investigational Site, Godoy Cruz, M5501ARP, Argentina|Novo Nordisk Investigational Site, Bad Neuenahr-Ahrweiler, 53474, Germany|Novo Nordisk Investigational Site, Gelnhausen, 63571, Germany|Novo Nordisk Investigational Site, Mainz, 55116, Germany|Novo Nordisk Investigational Site, Marburg, 35039, Germany|Novo Nordisk Investigational Site, Rehlingen-Siersburg, 66780, Germany|Novo Nordisk Investigational Site, St. Ingbert, 66386, Germany|Novo Nordisk Investigational Site, Völklingen, 66333, Germany|Novo Nordisk Investigational Site, Bialystok, 15-445, Poland|Novo Nordisk Investigational Site, Lublin, 20-044, Poland|Novo Nordisk Investigational Site, Torun, 87-100, Poland|Novo Nordisk Investigational Site, Warszawa, 00-911, Poland|Novo Nordisk Investigational Site, Carolina, 00983, Puerto Rico|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Saint-Petersburg, 194358, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 195213, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 199034, Russian Federation|Novo Nordisk Investigational Site, Belgrade, 11000, Serbia|Novo Nordisk Investigational Site, Bratislava, 851 01, Slovakia|Novo Nordisk Investigational Site, Kosice, 04-001, Slovakia|Novo Nordisk Investigational Site, Lubochna, 03491, Slovakia|Novo Nordisk Investigational Site, Koper, SI-6000, Slovenia|Novo Nordisk Investigational Site, Maribor, 2000, Slovenia|Novo Nordisk Investigational Site, Novo mesto, 8000, Slovenia|Novo Nordisk Investigational Site, Málaga, 29006, Spain|Novo Nordisk Investigational Site, Málaga, 29009, Spain|Novo Nordisk Investigational Site, Sanlúcar de Barrameda, 11540, Spain|Novo Nordisk Investigational Site, Ankara, 06110, Turkey|Novo Nordisk Investigational Site, Istanbul, 34096, Turkey|Novo Nordisk Investigational Site, Istanbul, 34098, Turkey|Novo Nordisk Investigational Site, Istanbul, 34722, Turkey|Novo Nordisk Investigational Site, Samsun, 55139, Turkey
URL: https://clinicaltrials.gov/show/NCT01232491

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress