Pioglitazone HCl and rosiglitazone will be evaluated and compared for their lipid-altering
potential, as measured by the fasting triglyceride levels, in subjects with type 2 diabetes
mellitus and dyslipidemia.
Inclusion Criteria:
- The subject is male or female, 35 years of age or older.
- The subject has type 2 diabetes, based on WHO criteria.
- The subject has a fasting serum C-peptide greater then or equal to 1 ng/mL.
- The subject has HbA1c greater then or equal to 7% and less then or equal to 11% (if
naïve to oral anti-hyperglycemic medications), or less then or equal to 9. 5% (if
treated with oral anti-hyperglycemic monotherapy).
- The subject has a fasting triglyceride level greater then or equal to 150 mg/dL and
less then or equal to 600 mg/dL and a fasting direct LDL-C less then or equal to 130
mg/dL.
Exclusion Criteria:
- The subject was treated with a drug lacking regulatory approval within 30 days of
Visit 1 of the study.
- The subject was treated with insulin, systemic glucocorticoid therapy (excluding
topical and inhaled preparations), combination glycemic therapy (2 or more oral
antidiabetic medications), any lipid-lowering agent (including nicotinic acid,
fibrates, bile acid resin binders, statins, d-thyroxine, or neomycin), or any weight
loss agent (prescription or over the counter) within 60 days of Visit 1 of the study.
- The subject is pregnant, breast feeding, or intending to become pregnant during the
study.
- The subject has serum creatine, urine protein outside predefined limits at Visit 1 of
the study.
- The subject has ALT or AST greater then or equal to 1. 5 times the upper limit of
normal at Visit 1, significant clinical signs or symptoms of liver disease, or history
of signs or symptoms of liver disease (such as jaundice or elevated ALT) while treated
with any thiazolidinedione.
- The subject has clinical or biochemical evidence of hypothyroid or hyperthyroid
condition; has a history of myocardial infarction, acute cardiovascular event or heart
surgery within 6 months of Visit 1 of the study; has functional New York Heart
Association Cardiac Class III or IV disease; is receiving renal dialysis or has
received a renal transplant; or is undergoing therapy for a malignancy other than
basal cell or squamous cell skin cancer.
Birmingham, Alabama 35234, United States
Anniston, Alabama 36207, United States
Tucson, Arizona 85710, United States
Los Angeles, California 90095, United States
Fremont, California 94538, United States
Santa Barbara, California 93105, United States
Concord, California 94520, United States
Santa Rosa, California 95405, United States
San Diego, California 92120, United States
Palos Verdes Estates, California 90274, United States
Aurora, Colorado 80010, United States
Englewood, Colorado 80110, United States
Hamden, Connecticut 06518, United States
Avon, Connecticut 06001, United States
Miami, Florida 33136, United States
Miami, Florida 33133, United States
Longwood, Florida 32750, United States
Atlanta, Georgia 30342, United States
Fayetteville, Georgia 30214, United States
Honolulu, Hawaii 96814, United States
Idaho Falls, Idaho 83404, United States
Chicago, Illinois 60610, United States
South Bend, Indiana 46601, United States
Indianapolis, Indiana 46202, United States
New Orleans, Louisiana 70127, United States
Frederick, Maryland 21702, United States
Baltimore, Maryland 21204, United States
Waltham, Massachusetts 02453, United States
Salisbury, Massachusetts 01952, United States
South Yarmouth, Massachusetts 02664, United States
Minneapolis, Minnesota 55416, United States
Chesterfield, Missouri 63017, United States
Omaha, Nebraska, United States
East Setauket, New York 11733, United States
New York, New York 10025, United States
Staten Island, New York 10305, United States
Rochester, New York 14607, United States
Endwell, New York 13760, United States
Durham, North Carolina 27713, United States
Greenville, North Carolina 27834, United States
Morehead City, North Carolina 28557, United States
Wilmington, North Carolina 28412, United States
Charlotte, North Carolina 28211, United States
Columbus, Ohio 43210, United States
Franklin, Ohio 45005, United States
Tulsa, Oklahoma 74136, United States
Portland, Oregon 97201, United States
Salem, Oregon 97302, United States
Philadelphia, Pennsylvania 19124, United States
Pottstown, Pennsylvania 19464, United States
Providence, Rhode Island 02908, United States
Mount Pleasant, South Carolina 29464, United States
Knoxville, Tennessee 37909, United States
Memphis, Tennessee 38119, United States
Lake Jackson, Texas 77566, United States
Dallas, Texas 75390, United States
San Antonio, Texas 78229, United States
Houston, Texas 77024, United States
Conroe, Texas 77384, United States
Beaumont, Texas 77701, United States
Ogden, Utah 84403, United States
Virginia Beach, Virginia 23455, United States
Newport News, Virginia 23606, United States
Mechanicsville, Virginia 23111, United States
Federal Way, Washington 98003, United States
Wenatchee, Washington 98801, United States
Milwaukee, Wisconsin 53209, United States
