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

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pioglitazone; Rosiglitazone

Criteria

Inclusion Criteria:

• 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%.

Exclusion Criteria:

• 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.