This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled
(glibenclamide) study of tesaglitazar in patients with type 2 diabetes, not adequately
controlled on diet and lifestyle advice alone during the run-in period. The study comprises
a 6 week placebo single blind run in period followed by a 52-week double blind treatment
period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to
optimal effect or highest tolerable dose during the first 12 weeks.
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
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Provision of a written informed consent
- Men or women who are >=18 years of age
- Female patients: postmenopausal, hysterectomized, or if of childbearing potential,
using a reliable method of birth control
- Diagnosed with type 2 diabetes
- Treated with diet alone or treatment with a single oral antidiabetic agent or low
doses of two oral antidiabetic agents
Exclusion Criteria:
- Type 1 diabetes
- New York Heart Association heart failure Class III or IV
- Treatment with chronic insulin
- History of hypersensitivity or intolerance to any peroxisome proliferator-activated
receptor agonist (like Actos or Avandia), fenofibrate, metformin or
3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
- History of drug-induced myopathy or drug-induced creatine kinase elevation, liver
enzyme elevations, neutropenia (low white blood cells)
- Creatinine levels above twice the normal range
- Creatine kinase above 3 times the upper limit of normal
- Received any investigational product in other clinical studies within 12 weeks
- Any clinically significant abnormality identified on physical examination, laboratory
tests or electrocardiogram, which in the judgment of the investigator would
compromise the patient's safety or successful participation in the clinical study
Research Site, Antwerpen, Belgium
Research Site, Braine-L'alleud, Belgium
Research Site, Hasselt, Belgium
Research Site, Liege, Belgium
Research Site, Merksem, Belgium
Research Site, Sint-Gillis-Waas, Belgium
Research Site, Steenokkerzeel, Belgium
Research Site, Shatin, N.T., Hong Kong
Research Site, Balatonfüred, Hungary
Research Site, Budapest, Hungary
Research Site, Kaposvár, Hungary
Research Site, Kecskemét, Hungary
Research Site, Székesfehérvár, Hungary
Research Site, Arenzano, Italy
Research Site, Chiavari (GE), Italy
Research Site, Chieri, Italy
Research Site, Gubbio (PG), Italy
Research Site, Milano, Italy
Research Site, Napoli, Italy
Research Site, Padova, Italy
Research Site, Perugia, Italy
Research Site, Piacenza, Italy
Research Site, Reggio Calabria, Italy
Research Site, Reggio Emilia, Italy
Research Site, Rho, Italy
Research Site, Roma, Italy
Research Site, Udine, Italy
Research Site, Kuala Lampur, Malaysia
Research Site, Veracruz, Mexico
Research Site, Bergen, Norway
Research Site, Kongsvinger, Norway
Research Site, Lysaker, Norway
Research Site, Oslo, Norway
Research Site, Skedsmokorset, Norway
Research Site, Sørumstand, Norway
Research Site, Trondheim, Norway
Research Site, Ås, Norway
Research Site, Manila, Philippines
Research Site, Pasig City, Philippines
Research Site, Kraków, Poland
Research Site, Lublin, Poland
Research Site, P³ock, Poland
Research Site, Toruñ, Poland
Research Site, Tychy, Poland
Research Site, Warszawa, Poland
Research Site, £ód?, Poland
Research Site, Bratislava, Slovakia
Research Site, Ilava, Slovakia
Research Site, Kosice, Slovakia
Research Site, Kysucke Nove Mesto, Slovakia
Research Site, Lubochna, Slovakia
Research Site, Lucenec, Slovakia
Research Site, Nitra, Slovakia
Research Site, Presov, Slovakia
Research Site, Trnava, Slovakia
Research Site, Cape Town, South Africa
Research Site, Durban, South Africa
Research Site, Houghton Gauteng, South Africa
Research Site, Changhua, Taiwan
Research Site, Taichung, Taiwan
Research Site, Taipei, Taiwan
Research Site, Bangkok, Thailand
Research Site, México, D.f., Mexico
Research Site, Guadalajara, Jalisco, Mexico
Research Site, Zapopan, Jalisco, Mexico
Research Site, Kubang Kerian, Kota Bharu, Malaysia