This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week 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
555
Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c)
Changes in the following variables from baseline to the end of the randomized treatment period:
• 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 (triglyceride [TG], total cholesterol, high-density lipoprotein cholesterol [HDL C], non-HDL C, low-density lipoprotein cholesterol [LDL C], apolipoproteins [Apo] A-I, Apo B, Apo CIII, free fatty acids, lipoprotein particle size and c
• C-reactive protein, LDL C/HDL C ratio and Apo B/Apo A-I ratio
• FPG, homeostasis assessment model, insulin, proinsulin, C-peptide
• Tumor necrosis factor-alpha, intracellular adhesion molecule-1
• Fibrinogen
• Urinary albumin excretion
• Waist/hip ratio
• Responder analyses for HbA1c, FPG, TG, HDL C, total cholesterol, non HDL C and LDL C according to pre-specified values
• Proportion of patients reaching pre-specified target levels for HbA1c, FPG, TG, HDL C, non-HDL C and LDL C
• Pharmacokinetics of tesaglitazar
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Research Site
Adelaide, Australia
Research Site
Brisbane, Australia
Research Site
Cairns, Australia
Research Site
Geelong, Australia
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Melbourne, Australia
Research Site
Perth, Australia
Research Site
Sydney, Australia
Research Site
Tasmania, Australia
Research Site
Angers, France
Research Site
Hyères, France
...and 74 more locations
• 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