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Clinical Trial Details

Trial ID: L2854
Source ID: NCT00242372
Associated Drug: Tesaglitazar 0.5
Title: GALLANT 9 Tesaglitazar vs. Placebo in Combination With Insulin
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Tesaglitazar 0.5|DRUG: Insulin at least 30 units/day
Outcome Measures: Primary: Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | Secondary: Changes in the following variables from baseline to the end of the randomized treatment period:|The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide from baseline to the end of the randomized treatment period|Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period|Lipid parameters (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c|C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio|FPG, homeostasis assessment model, insulin, proinsulin, C-peptide|Tumor necrosis factor-alpha, intracellular adhesion molecule-1|Fibrinogen|Urinary albumin excretion|Waist/hip ratio|Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values|Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C|Pharmacokinetics of tesaglitazar|Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination|To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 370
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2004-08
Completion Date: 2006-03
Results First Posted:
Last Update Posted: 2009-04-22
Locations: Research Site, Birmingham, Alabama, United States|Research Site, Phoenix, Arizona, United States|Research Site, Tuscson, Arizona, United States|Research Site, Fresno, California, United States|Research Site, Greenbrae, California, United States|Research Site, La Jolla, California, United States|Research Site, Northridge, California, United States|Research Site, Riverside, California, United States|Research Site, San Diego, California, United States|Research Site, Santa Monica, California, United States|Research Site, Spring Valley, California, United States|Research Site, Walnut Creek, California, United States|Research Site, West Hills, California, United States|Research Site, Waterbury, Connecticut, United States|Research Site, Washington, District of Columbia, United States|Research Site, Gainesville, Florida, United States|Research Site, Hollywood, Florida, United States|Research Site, Jacksonville, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Palm Harbor, Florida, United States|Research Site, West Palm Beach, Florida, United States|Research Site, Augusta, Georgia, United States|Research Site, Dunwoody, Georgia, United States|Research Site, Boise, Idaho, United States|Research Site, Chicago Heights, Illinois, United States|Research Site, Chicago, Illinois, United States|Research Site, Gurnee, Illinois, United States|Research Site, Maywood, Illinois, United States|Research Site, Springfield, Illinois, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Wichita, Kansas, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Baltimore, Maryland, United States|Research Site, Bethesda, Maryland, United States|Research Site, Cadillac, Michigan, United States|Research Site, Richmond Heights, Missouri, United States|Research Site, St Louis, Missouri, United States|Research Site, Omaha, Nebraska, United States|Research Site, North Las Vegas, Nevada, United States|Research Site, Pahrump, Nevada, United States|Research Site, Dover, New Hampshire, United States|Research Site, Roseland, New Jersey, United States|Research Site, Albuquerque, New Mexico, United States|Research Site, Brooklyn, New York, United States|Research Site, New Hyde Park, New York, United States|Research Site, Charlotte, North Carolina, United States|Research Site, Wilmington, North Carolina, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Kettering, Ohio, United States|Research Site, Toledo, Ohio, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Medford, Oregon, United States|Research Site, Portland, Oregon, United States|Research Site, Altoona, Pennsylvania, United States|Research Site, Cheswick, Pennsylvania, United States|Research Site, Erie, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Columbia, South Carolina, United States|Research Site, Greer, South Carolina, United States|Research Site, Corpus Christie, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, Fort Worth, Texas, United States|Research Site, Houston, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Richmond, Virginia, United States|Research Site, Bellevue, Washington, United States|Research Site, Renton, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States|Research Site, Madison, Wisconsin, United States
URL: https://clinicaltrials.gov/show/NCT00242372

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress