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Clinical Trial Details

Trial ID: L2525
Source ID: NCT00909480
Associated Drug: Insulin Detemir
Title: Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes
Acronym: EFFICACY
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00909480/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: insulin glargine
Outcome Measures: Primary: Change in HbA1c From Baseline, Week 0, Week 26 | Secondary: Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%, The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%, Week 26|Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia, The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment., Week 26|Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%, The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less, Week 26|Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia, The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment., Week 26|Fasting Plasma Glucose (FPG), Week 26|Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast, The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time., Week 26|Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles), Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am., Week 26|Incidence of Hypoglycaemic Episodes During the Trial, Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., Weeks 0-26|Hypoglycaemic Episodes, Diurnal, Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., Weeks 0-26|Hypoglycaemic Episodes, Nocturnal, Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., Weeks 0-26|Hypoglycemic Episodes, Unclassifiable, Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L., Weeks 0-26|Change in Body Weight From Baseline, Week 0, Week 26|Number of Subjects Having the Adverse Event "Incorrect Dose Administered", Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications", Weeks 0-26
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 457
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-05
Completion Date: 2010-06
Results First Posted: 2011-09-27
Last Update Posted: 2017-03-10
Locations: Novo Nordisk Investigational Site, Litchfield Park, Arizona, 85340, United States|Novo Nordisk Investigational Site, Searcy, Arkansas, 72143, United States|Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Long Beach, California, 90822, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, 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, Aurora, Colorado, 80045, United States|Novo Nordisk Investigational Site, Norwalk, Connecticut, 06851, United States|Novo Nordisk Investigational Site, Hollywood, Florida, 33021, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32207, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Miami, Florida, 33143, United States|Novo Nordisk Investigational Site, Ocala, Florida, 34471, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32804, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Ponte Vedra, Florida, 32081, United States|Novo Nordisk Investigational Site, Winter Haven, Florida, 33880, United States|Novo Nordisk Investigational Site, Powder Springs, Georgia, 30127, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Independence, Kansas, 67301-3263, United States|Novo Nordisk Investigational Site, Shawnee Mission, Kansas, 66204, United States|Novo Nordisk Investigational Site, Portland, Maine, 04101, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Clilfton, New Jersey, 07011, 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, Syracuse, New York, 13210, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Winston Salem, North Carolina, 27103, United States|Novo Nordisk Investigational Site, Cayahoga Falls, Ohio, 44223, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45406, United States|Novo Nordisk Investigational Site, Gallipolis, Ohio, 45631-1560, United States|Novo Nordisk Investigational Site, Tulsa, Oklahoma, 74104, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Clarion, Pennsylvania, 16214, United States|Novo Nordisk Investigational Site, Lancaster, Pennsylvania, 17601, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19104, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19107, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Spartanburg, South Carolina, 29303, United States|Novo Nordisk Investigational Site, Taylors, South Carolina, 29687, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37404, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78404, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Houston, Texas, 77025, United States|Novo Nordisk Investigational Site, Hurst, Texas, 76054, United States|Novo Nordisk Investigational Site, Odessa, Texas, 79761, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States|Novo Nordisk Investigational Site, St. George, Utah, 84790, United States|Novo Nordisk Investigational Site, Virginia Beach, Virginia, 23462, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, 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, B1704ETD, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1405, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1429, Argentina|Novo Nordisk Investigational Site, Mar del Plata, B7600FZN, Argentina|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600028, India|Novo Nordisk Investigational Site, Thriruvananthapuram, 695 032, India|Novo Nordisk Investigational Site, Seoul, 110-746, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 130-701, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 138-736, Korea, Republic of|Novo Nordisk Investigational Site, Seoul, 139-707, Korea, Republic of|Novo Nordisk Investigational Site, Manati, 00674, Puerto Rico|Novo Nordisk Investigational Site, Trujillo Alto, 00976, Puerto Rico|Novo Nordisk Investigational Site, Bangkok, 10110, Thailand|Novo Nordisk Investigational Site, Bangkok, 10330, Thailand|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand|Novo Nordisk Investigational Site, Pathumthani, 12120, Thailand
URL: https://clinicaltrials.gov/show/NCT00909480

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress