Status:
COMPLETED
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE3
Brief Summary
Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase t...
Detailed Description
Thiazolidinediones (TZDs) are pharmacological ligands for the nuclear receptor peroxisome-proliferator-activated receptor gamma (PPAR-γ). When activated, the receptor binds with response elements on D...
Eligibility Criteria
Inclusion
- Type 2 diabetes, men and women, WHO criteria, aged 35-70 years
- HbA1c 7.5-10.0%
- BMI 26-39 Kg/m2
- Either receiving dietary therapy only or monotherapy with either sulfonylurea or metformin
- Already on statin therapy
Exclusion
- Cardiovascular disease
- Renal disease
- Other systemic disease
- Abnormal liver function tests (ALT or AST\>1.5 X ULN)
- Uncontrolled hypertension (BP \>160/110)
- Triglyceride levels \>400 mg/dl
- Lipid modifying drugs; fibrates, ezetimibe, niacin, bile sequestrants, but not statins (see below),
- Estrogen treatment or thyroid disease
- Psychiatric condition or substance abuse
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01156597
Start Date
April 1 2008
End Date
September 1 2010
Last Update
November 21 2014
Active Locations (1)
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1
Diabetes Research Institute
Miami, Florida, United States, 33136