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Clinical Trial Details

Trial ID: L6142
Source ID: NCT00634842
Associated Drug: Insulin Detemir
Title: Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily
Acronym: TITRATE™
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00634842/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: insulin detemir
Outcome Measures: Primary: Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%, Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment, week 20 | Secondary: Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%, Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment, week 20|Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline, Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20, week -2, week 20|Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only), Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows: * If subject was unable to treat himself: Major incidence. * If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence. * If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only., weeks 0-20
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 244
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-02
Completion Date: 2008-10
Results First Posted: 2009-12-22
Last Update Posted: 2017-03-10
Locations: Novo Nordisk Investigational Site, Goodyear, Arizona, 85395, United States|Novo Nordisk Investigational Site, Scottsdale, Arizona, 85251-5638, United States|Novo Nordisk Investigational Site, Searcy, Arkansas, 72143, United States|Novo Nordisk Investigational Site, Artesia, California, 90701, United States|Novo Nordisk Investigational Site, Escondido, California, 92025, United States|Novo Nordisk Investigational Site, Fullerton, California, 92835-3404, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90036, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Orange, California, 92869, 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, Parker, Colorado, 80138-8789, United States|Novo Nordisk Investigational Site, Norwalk, Connecticut, 06851, United States|Novo Nordisk Investigational Site, Prospect, Connecticut, 06712, United States|Novo Nordisk Investigational Site, Boca Raton, Florida, 33433, United States|Novo Nordisk Investigational Site, Clearwater, Florida, 33755-2138, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32204, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32205, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Lake Mary, Florida, 32746, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Athens, Georgia, 30606, United States|Novo Nordisk Investigational Site, Roswell, Georgia, 30076, United States|Novo Nordisk Investigational Site, Savannah, Georgia, 31406, United States|Novo Nordisk Investigational Site, Idaho Falls, Idaho, 83404-7596, United States|Novo Nordisk Investigational Site, Chicago, Illinois, 60607, United States|Novo Nordisk Investigational Site, Terre Haute, Indiana, 47802, United States|Novo Nordisk Investigational Site, Topeka, Kansas, 66606, United States|Novo Nordisk Investigational Site, New Orleans, Louisiana, 70121, United States|Novo Nordisk Investigational Site, Pikesville, Maryland, 21208-3737, United States|Novo Nordisk Investigational Site, St. Paul, Minnesota, 55108, United States|Novo Nordisk Investigational Site, Chesterfield, Missouri, 63017-3632, United States|Novo Nordisk Investigational Site, St. Louis, Missouri, 63141, United States|Novo Nordisk Investigational Site, Omaha, Nebraska, 68114, United States|Novo Nordisk Investigational Site, Las Vegas, Nevada, 89101, United States|Novo Nordisk Investigational Site, Berlin, New Jersey, 08009, United States|Novo Nordisk Investigational Site, Camden, New Jersey, 08104, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, New York, New York, 10023, United States|Novo Nordisk Investigational Site, Staten Island, New York, 10301, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Shelby, North Carolina, 28152, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, 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, Mentor, Ohio, 44060, United States|Novo Nordisk Investigational Site, Oklahoma City, Oklahoma, 73103, United States|Novo Nordisk Investigational Site, Altoona, Pennsylvania, 16602, United States|Novo Nordisk Investigational Site, Norristown, Pennsylvania, 19401, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19104, 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, Arlington, Texas, 76014, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75231, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Houston, Texas, 77024, United States|Novo Nordisk Investigational Site, Houston, Texas, 77025, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, 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, Spokane, Washington, 99204-2629, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99218, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Caguas, 00725, Puerto Rico|Novo Nordisk Investigational Site, San Juan, 00921, Puerto Rico|Novo Nordisk Investigational Site, Trujillo Alto, 00976, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00634842

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress