This is a 24-week randomized, double-blind, multi-center, placebo-controlled study of tesaglitazar in patients with type 2 diabetes who are not adequately controlled on insulin (along or in combination with one or more oral antidiabetic agents in addition to diet and lifestyle advice). The study comprises a 3-week enrollment period and a 24-week randomized, double blind, multi-center, placebo-controlled treatment period and a 3-week follow-up. Patients must receive at least 30 units of insulin per day and will continue their current oral antidiabetic treatment regimen throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
370
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 from baseline to the end of the randomized treatment period
Insulin sensitivity by assessment of change in the calculated variable homeostasis assessment model from baseline to the end of the randomized treatment period
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
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Research Site
Birmingham, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tuscson, Arizona, United States
Research Site
Fresno, California, United States
Research Site
Greenbrae, California, United States
Research Site
La Jolla, California, United States
Research Site
Northridge, California, United States
Research Site
Riverside, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Monica, California, United States
...and 61 more locations
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
To validate the Work Productivity and Activity Impairment-Diabetes Questionnaire (WPAI-Diabetes) and the Diabetes Productivity Impairment Questionnaire (DPIQ) in patients with type 2 diabetes and to explore the effects of tesaglitazar (0.5 mg) on pati