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Clinical Trial Details

Trial ID: L3174
Source ID: NCT00280865
Associated Drug: Tesaglitazar
Title: GLAD: Dose-Finding, Efficacy, and Safety of AZ 242 (Tesaglitazar) in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: Tesaglitazar|DRUG: Pioglitazone|BEHAVIORAL: Dietary and Lifestyle Modification Counseling
Outcome Measures: Primary: Absolute change from baseline to end of randomized treatment period in fasting plasma glucose (FPG) | Secondary: Changes in the following variables from baseline to the end of the randomized treatment period:|The change in plasma glucose and insulin during an oral glucose tolerance test|Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model|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|Change in insulin levels and hemoglobin A1c (HbA1c) levels|Responder analyses for FPG, TG, and HDL C according to pre-specified values|Pharmacokinetics of tesaglitazar|To assess the burden of type 2 diabetes mellitus in patients through the administration of the SF-36 health survey and the Well-Being Questionnaire (W BQ12) and comparing the study population data to published national and international normative data|To evaluate diabetes-specific instruments, Audit of Diabetes Dependent Quality of Life (ADDQoL) and The Diabetes Treatment Satisfaction Questionnaire (DTSQ) (s and c) in the study population and estimate the effect size of the instruments in patients r
Sponsor/Collaborators: Sponsor: AstraZeneca
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 500
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
Start Date: 2002-04
Completion Date: 2003-06
Results First Posted:
Last Update Posted: 2006-07-31
Locations: Research Site, Birmingham, Alabama, United States|Research Site, Huntsville, Alabama, United States|Research Site, Montgomery, Alabama, United States|Research Site, Mesa, Arizona, United States|Research Site, Phoenix, Arizona, United States|Research Site, Tucson, Arizona, United States|Research Site, Alhambra, California, United States|Research Site, Anaheim, California, United States|Research Site, Dinuba, California, United States|Research Site, Escondido, California, United States|Research Site, Fresno, California, United States|Research Site, Greenbrae, California, United States|Research Site, Long Beach, California, United States|Research Site, Mission Viejo, California, United States|Research Site, Orange, California, United States|Research Site, Sacramento, California, United States|Research Site, San Diego, California, United States|Research Site, Walnut Creek, California, United States|Research Site, Stamford, Connecticut, United States|Research Site, Waterbury, Connecticut, United States|Research Site, Washington, District of Columbia, United States|Research Site, Brandon, Florida, United States|Research Site, Coral Gables, Florida, United States|Research Site, DeLand, Florida, United States|Research Site, Gainesville, Florida, United States|Research Site, Hollywood, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Augusta, Georgia, United States|Research Site, Blue Ridge, Georgia, United States|Research Site, Dunwoody, Georgia, United States|Research Site, Gurnee, Illinois, United States|Research Site, Springfield, Illinois, United States|Research Site, Evansville, Indiana, United States|Research Site, Indianapolis, Indiana, United States|Research Site, Wichita, Kansas, United States|Research Site, Louisville, Kentucky, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Bangor, Maine, United States|Research Site, Baltimore, Maryland, United States|Research Site, Salisbury, Massachusetts, United States|Research Site, Worcester, Massachusetts, United States|Research Site, Ann Arbor, Michigan, United States|Research Site, Cadillac, Michigan, United States|Research Site, Jackson, Mississippi, United States|Research Site, St. Louis, Missouri, United States|Research Site, Omaha, Nebraska, United States|Research Site, Henderson, Nevada, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Pahrump, Nevada, United States|Research Site, Lawrenceville, New Jersey, United States|Research Site, Newark, New Jersey, United States|Research Site, Albany, New York, United States|Research Site, Brooklyn, New York, United States|Research Site, Buffalo, New York, United States|Research Site, New Hyde Park, New York, United States|Research Site, New York, New York, United States|Research Site, Charlotte, North Carolina, United States|Research Site, Hickory, North Carolina, United States|Research Site, Winston-Salem, North Carolina, United States|Research Site, Canfield, Ohio, United States|Research Site, Cincinnati, Ohio, United States|Research Site, Columbus, Ohio, United States|Research Site, Kettering, Ohio, United States|Research Site, Lakewood, Ohio, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Eugene, Oregon, United States|Research Site, Altoona, Pennsylvania, United States|Research Site, Cheswick, Pennsylvania, United States|Research Site, Penndel, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Warminster, Pennsylvania, United States|Research Site, Warwick, Rhode Island, United States|Research Site, Columbia, South Carolina, United States|Research Site, Ninety Six, South Carolina, United States|Research Site, Summerville, South Carolina, United States|Research Site, Sioux Falls, South Dakota, United States|Research Site, Arlington, Texas, United States|Research Site, Corpus Christi, Texas, United States|Research Site, Dallas, Texas, United States|Research Site, Lubbock, Texas, United States|Research Site, North Richland Hills, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Salt Lake City, Utah, United States|Research Site, Falls Church, Virginia, United States|Research Site, Norfolk, Virginia, United States|Research Site, Richmond, Virginia, United States|Research Site, Edmonds, Washington, United States|Research Site, Renton, Washington, United States|Research Site, Huntington, West Virginia, United States|Research Site, Edmonton, Alberta, Canada|Research Site, Burlington, Ontario, Canada|Research Site, Courtice, Ontario, Canada|Research Site, Granby, Quebec, Canada|Research Site, Laval, Quebec, Canada|Research Site, Longueuil, Canada|Research Site, Montreal, Canada|Research Site, Sherbrooke, Canada|Research Site, Windsor, Canada|Research Site, Winnipeg, Canada|Research Site, Andard, France|Research Site, Angers, France|Research Site, Avrille, France|Research Site, Chalonnes-sur-Loire, France|Research Site, Montrevault, France|Research Site, Segre, France|Research Site, Tierce, France|Research Site, Colonia Seccion XVI, Mexico|Research Site, Colonia Valle, Mexico|Research Site, Delegacion Cuauhtemoc, Mexico
URL: https://clinicaltrials.gov/show/NCT00280865

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