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Clinical Trial Details

Trial ID: L5221
Source ID: NCT00537303
Associated Drug: Insulin Detemir
Title: Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00537303/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: insulin detemir|DRUG: insulin aspart|DRUG: insulin aspart
Outcome Measures: Primary: Glycosylated Haemoglobin A1c (HbA1c), Analysed for the full analysis set., week 36|Glycosylated Haemoglobin A1c (HbA1c), Measured for the Per Protocol analysis set., week 36 | Secondary: Hypoglycaemic Episodes, Number of hypoglycaemic episodes from Week 0 to Week 36, 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 (56 mg/dL). 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 0-36|Biochemistry: Serum Alanine Aminotransferase, Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory., week 36|Haematology: Haemoglobin Measured in Blood, Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory., week 36|Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide, High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory., week 36
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 296
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-10
Completion Date: 2009-03
Results First Posted: 2010-08-13
Last Update Posted: 2017-03-10
Locations: Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Mission Viejo, California, 92691, United States|Novo Nordisk Investigational Site, Miami, Florida, 33136, United States|Novo Nordisk Investigational Site, Athens, Georgia, 30606, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Des Moines, Iowa, 50314-3027, United States|Novo Nordisk Investigational Site, Lawrenceville, New Jersey, 08648, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28803, United States|Novo Nordisk Investigational Site, Dayton, Ohio, 45439, United States|Novo Nordisk Investigational Site, Kettering, Ohio, 45429, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Chattanooga, Tennessee, 37411, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, 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, 77030, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Newport News, Virginia, 23606, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23294, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53209, United States|Novo Nordisk Investigational Site, Århus C, 8000, Denmark|Novo Nordisk Investigational Site, Espoo, FI-02650, Finland|Novo Nordisk Investigational Site, Oulu, FI-90100, Finland|Novo Nordisk Investigational Site, Oulu, FI-90220, Finland|Novo Nordisk Investigational Site, Tampere, 33100, Finland|Novo Nordisk Investigational Site, Vaasa, FIN-61500, Finland|Novo Nordisk Investigational Site, Vantaa, FI-01620, Finland|Novo Nordisk Investigational Site, Belgrade, 11000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Nis, 18000, Former Serbia and Montenegro|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Pointe à Pitre, 97159, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Den Bosch, 5216 GC, Netherlands|Novo Nordisk Investigational Site, Eindhoven, 5631 BM, Netherlands|Novo Nordisk Investigational Site, Etten-Leur, 4872 LP, Netherlands|Novo Nordisk Investigational Site, Hulst, 4561 NV, Netherlands|Novo Nordisk Investigational Site, Utrecht, 3563 AZ, Netherlands|Novo Nordisk Investigational Site, Woerden, 3443 GG, Netherlands|Novo Nordisk Investigational Site, Jessheim, 2050, Norway|Novo Nordisk Investigational Site, Oslo, 0160, Norway|Novo Nordisk Investigational Site, Sarpsborg, 1702, Norway|Novo Nordisk Investigational Site, Stavanger, 4011, Norway|Novo Nordisk Investigational Site, Tromsø, 9038, Norway|Novo Nordisk Investigational Site, Tønsberg, 3116, Norway|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Moscow, 123448, Russian Federation|Novo Nordisk Investigational Site, Moscow, 127644, Russian Federation|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1818, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0001, South Africa|Novo Nordisk Investigational Site, Cáceres, 10004, Spain|Novo Nordisk Investigational Site, Inca, 07300, Spain|Novo Nordisk Investigational Site, Madrid, 28034, Spain|Novo Nordisk Investigational Site, Mostoles - Madrid -, 28935, Spain|Novo Nordisk Investigational Site, Málaga, 29010, Spain|Novo Nordisk Investigational Site, Mérida, 06800, Spain|Novo Nordisk Investigational Site, Santiago de Compostela, 15706, Spain|Novo Nordisk Investigational Site, Göteborg, 417 17, Sweden|Novo Nordisk Investigational Site, Mölndal, 431 80, Sweden|Novo Nordisk Investigational Site, Ängelholm, 262 91, Sweden|Novo Nordisk Investigational Site, Aberdeen, AB25 1LD, United Kingdom|Novo Nordisk Investigational Site, Coventry, CV2 2DX, United Kingdom|Novo Nordisk Investigational Site, Livingstone, EH54 6PP, United Kingdom|Novo Nordisk Investigational Site, Llanelli, SA14 8QF, United Kingdom|Novo Nordisk Investigational Site, Llantrisant, CF72 8XR, United Kingdom|Novo Nordisk Investigational Site, Reading, RG7 3SQ, United Kingdom|Novo Nordisk Investigational Site, Rugby, CV22 5PX, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00537303

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress