Pioglitazone Study of Triglyceride Changes in Subjects With Type 2 Diabetes After Conversion From Rosiglitazone.

Completed · Phase 4

Conditions studied: Diabetes Mellitus

In brief

The purpose of this study is to measure the triglyceride changes in subjects with type 2 diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from rosiglitazone.

Key facts

Study ID

NCT00672919

Run by

Takeda

People needed

305

Starts

2003-11-01

Expected to finish

2004-08-01

Last updated by the study team

2012-02-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with type 2 diabetes mellitus
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study
• Has been taking a stable dose of rosiglitazone for greater than 90 days prior to screening.
• Has a triglyceride level greater than 200 mg per dL but less than 1000 mg per dL.
• Has been taking a stable statin therapy for greater than 90 days prior to screening.
• Has a glycosylated hemoglobin less than 10.5%.

You may not qualify if…

• Type 1 diabetes mellitus.
• Treated with Gemfibrozil within 90 days of screening.
• Previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
• The subject has an alanine aminotransaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
• Male subjects who have serum creatinine greater than 2.0 mg per dL and female subjects with serum creatinine greater than1.8 mg per dL.
• Unexplained microscopic hematuria greater than plus 1 confirmed by repeat testing.
• Male subjects who have hemoglobin less than 10.5 g per dL and female subjects who have hemoglobin less than 10.0 g per dL.
• Significant cardiovascular disease including, but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV
• Currently is participating in another investigational study or has participated in an investigational study within the past 30 days.
• Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
• Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• Glucocorticoids (eg. prednisone, cortisone, hydrocortisone, dexamethasone) with the exception of a topical glucocorticoid agent.
• Gemfibrozil
• Steroid-joint injections.
• Thiazolidinediones with the exception of the study medication.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Bellflower, California, United States
• Study site — Burlingame, California, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Pasadena, California, United States
• Study site — Arvada, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago Heights, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Fall River, Massachusetts, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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