Type 2 Diabetes
Conditions
Brief summary
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)
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 the normal range * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HDL-C from baseline to the end of the randomized treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Central obesity (waist/hip ratio) | — |
| 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) | — |
| 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 | — |
| The proportion of patients reaching pre-specified target levels for HDL-C, TG, and non-HDL-C | — |
Countries
Brazil, Canada, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Malaysia, Norway, Philippines, Portugal, Russia, Singapore, South Africa, Switzerland, Taiwan
Outcome results
None listed