This is a prospective 24-week, randomized, parallel-group, multi-center, active-controlled (pioglitazone 45 mg) open-label study designed to assess the effects of tesaglitazar 2 mg per day on components of renal excretion of creatinine in type 2 diabetics. The study comprises a 2-week enrollment period, followed by a 24-week double blind treatment period and an 8-week follow-up period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
100
2 mg once daily in oral form
45 mg once daily in oral form
Research Site
Pasadena, California, United States
Research Site
Washington D.C., District of Columbia, United States
Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:
Glomerular filtration rate (GFR) by iothalamate clearance
Endogenous creatinine clearance
Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:
GFR by iothalamate clearance
Endogenous creatinine clearance
The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics
The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates
The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates
The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.
The safety and tolerability of tesaglitazar in type 2 diabetics by assessments of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, body weight, and physical examination.
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Research Site
Gainesville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Augusta, Georgia, United States
Research Site
Columbus, Georgia, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Reno, Nevada, United States
Research Site
Flushing, New York, United States
...and 11 more locations