This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
The change in HDL-C from baseline to the end of the randomized treatment period.
Changes in the following variables from baseline to the end of the randomized treatment period:
Lipid and lipoprotein variables (triglycerides [TG], non-HDL-C, total cholesterol, low-density lipoprotein cholesterol [LDL-C], lipoprotein particle size and concentration, free fatty acid, apolipoprotein [Apo] AI, Apo B, Apo CIII)
Responder analyses for HDL-C, TG, and non-HDL-C according to pre-specified values
The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C
Risk markers for cardiovascular disease (C-reactive protein, insulin, homeostasis model assessment, LDL-C/HDL-C ratio, very-low-density lipoprotein cholesterol/LDL-C ratio, Apo B/Apo AI ratio)
Central obesity (waist/hip ratio)
Pharmacokinetics of tesaglitazar
Safety and tolerability of tesaglitazar by assessment of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, hypoglycemic events, body weight, cardiac evaluation, and physical examination
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Research Site
Fortaleza, Ceará, Brazil
Research Site
Goiânia, Goiás, Brazil
Research Site
Porto Alegre, Rio Grande do Sul, Brazil
Research Site
São Paulo, São Paulo, Brazil
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Curitiba, Brazil
Research Site
Calgary, Alberta, Canada
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Surrey, British Columbia, Canada
Research Site
Bay Roberts, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
...and 142 more locations