This is a 24-week randomized, double-blind, multi-center, active-controlled (pioglitazone) study of tesaglitazar (0.5 mg and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 3-week enrollment period, 6 week placebo single blind run in period followed by a 24-week double blind treatment period and a 3-week follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,450
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
The change in fasting plasma glucose (FPG), insulin, proinsulin and C-peptide
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model
Lipid parameters
FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
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
Assess the effects on patient-reported outcomes using the Medical Outcomes Study Short Form-36 (SF-36)
Validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) (US only).
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Research Site
Altoona, Pennsylvania, United States
Research Site
Ciudad de Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Research Site
Moron- Buenos Aires, Argentina
Research Sites
Quilmes - Buenos Aires, Argentina
Research Site
Rosario, Argentina
Research Site
Salta, Argentina
Research Site
Curitiba, Brazil
Research Site
Edmonton, Alberta, Canada
Research Site
Abbotsford British Columbia, British Columbia, Canada
...and 64 more locations