This was a study of 30 mg to 45 mg of pioglitazone HCL (ACTOS) measuring triglyceride changes
in subjects with Type II Diabetes and dyslipidemia following treatment conversion from
rosiglitazone in combination with stable statin therapy.
Inclusion Criteria:
- The subject had type 2 diabetes mellitus as defined by the American Diabetes
Association (ADA) criteria.
- Female subjects of childbearing potential were nonpregnant and nonlactating and had a
negative urine pregnancy test result at screening prior to receiving any dose of study
drug.
- The subject had been taking a stable dose of rosiglitazone for ≥90 days prior to
screening.
- The subject had a triglyceride level ≥200 mg/dL but <1000 mg/dL.
- The subject had been taking a stable (same dose and same agent) statin therapy for >90
days prior to Screening. (Subjects may have taken additional, stable lipid lowering
therapy [same dose, same agent, for ≥90 days], including nicotinic acid, fibrates
[excluding gemfibrozil], bile acid resin binders, cholesterol absorption inhibitors,
d-thyroxine, or neomycin.)
- The subject had an A1C <10. 5%.
Exclusion Criteria:
- The subject had type 1 diabetes mellitus.
- The subject had been treated with gemfibrozil within 90 days of screening.
- The subject had a previous history of cancer, other than basal cell carcinoma, that
had not been in remission for at least 5 years before the first dose of study drug.
- The subject had an alanine aminotransferase (ALT) level greater than 2. 5 times the
upper limit of normal, active liver disease, or jaundice.
- Male subjects who had serum creatinine ≥2. 0 mg/dL and female subjects with serum
creatinine ≥1. 8 mg/dL.
- Subjects who had unexplained microscopic hematuria >+1 confirmed by repeat testing.
- Male subjects who had hemoglobin <10. 5 g/dL and female subjects who had hemoglobin
<10. 0 g/dL.
- Subjects who had significant cardiovascular disease, including but not limited to New
York Heart Association (NYHA) Functional (Cardiac) Classification III or IV.
- The subject was participating in another investigational study or participated in an
investigational study within 30 days prior to initiation of this study.
- The subject had any other serious disease or condition at Screening or at
randomization that might have affected life expectancy or made it difficult to
successfully manage and follow the subject according to the protocol.
Carolina, Puerto Rico
PoncE, Puerto Rico
Birmingham,, Alabama, United States
Tucson, Arizona, United States
Fresno,, California, United States
Long Beach, California, United States
La Jolla, California, United States
Bellflower, California, United States
Pasadena, California, United States
Burlingame, California, United States
Arvada, Colorado, United States
Norwalk, Connecticut, United States
Waterbury, Connecticut, United States
Aventura, Florida, United States
N. Miami Beach, Florida, United States
West Palm Beach, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tallahassee, Florida, United States
Jacksonville, Florida, United States
Columbus,, Georgia, United States
Idaho Falls, Idaho, United States
Chicago Heights, Illinois, United States
Evansville,, Indiana, United States
Des Moines, Iowa, United States
Lafayette, Louisiana, United States
Waltham, Massachusetts, United States
Fall River, Massachusetts, United States
Tupelo, Mississippi, United States
Chesterfield, Missouri, United States
Omaha, Nebraska, United States
Staten Island, New York, United States
Winston-Salem, North Carolina, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Centerville, Ohio, United States
Medford, Oregon, United States
Pittsburgh, Pennsylvania, United States
Meadville, Pennsylvania, United States
Warwick, Rhode Island, United States
Nashville, Tennessee, United States
Chattanooga, Tennessee, United States
Morristown, Tennessee, United States
Murfreesboro, Tennessee, United States
Midland, Texas, United States
Arlington, Texas, United States
San Antonio, Texas, United States
Houston, Texas, United States
Ogden, Utah, United States
Orange, Virginia, United States
Virginia Beach,, Virginia, United States
Man, West Virginia, United States
Wausau, Wisconsin, United States
