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Clinical Trial Details

Trial ID: L6592
Source ID: NCT00598793
Associated Drug: Biphasic Insulin Aspart
Title: Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy
Acronym: INITIATE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: biphasic insulin aspart|DRUG: insulin glargine|DRUG: metformin|DRUG: pioglitazone
Outcome Measures: Primary: HbA1c, after 28 weeks of treatment | Secondary: Postprandial glucose by 8-point SMBG|Number of subjects achieving HbA1c below 7%|Number of hypoglycemic episodes and adverse events|Weight change|Insulin dose
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 242
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2002-11
Completion Date: 2004-03
Results First Posted:
Last Update Posted: 2017-01-09
Locations: Novo Nordisk Investigational Site, Concord, California, 94520, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Melbourne, Florida, 32901, United States|Novo Nordisk Investigational Site, Melbourne, Florida, 32935, United States|Novo Nordisk Investigational Site, West Palm Beach, Florida, 33401, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30318, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30067, 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, Lexington, Kentucky, 40504-2681, United States|Novo Nordisk Investigational Site, Buffalo, New York, 14209, United States|Novo Nordisk Investigational Site, Asheville, North Carolina, 28803, United States|Novo Nordisk Investigational Site, Canton, Ohio, 44708, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43203, United States|Novo Nordisk Investigational Site, Medford, Oregon, 97504, United States|Novo Nordisk Investigational Site, Hershey, Pennsylvania, 17033, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, 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, 75246, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-8858, United States|Novo Nordisk Investigational Site, Houston, Texas, 77030, United States|Novo Nordisk Investigational Site, Midland, Texas, 79707, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78229, United States|Novo Nordisk Investigational Site, Warrenton, Virginia, 20186, United States|Novo Nordisk Investigational Site, Renton, Washington, 98055, United States
URL: https://clinicaltrials.gov/show/NCT00598793

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details