Status:
COMPLETED
Pioglitazone Study of Triglyceride Changes in Subjects With Type 2 Diabetes After Conversion From Rosiglitazone.
Lead Sponsor:
Takeda
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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.
Detailed Description
Diabetes mellitus is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes has a genetic predisposition, but lifestyl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00672919
Start Date
November 1 2003
End Date
August 1 2004
Last Update
February 28 2012
Active Locations (53)
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Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Bellflower, California, United States
4
Burlingame, California, United States