Type 2 Diabetes
Conditions
Brief summary
This is a 12-week study to determine the effect on glucose and lipids, safety, and tolerability of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) compared with placebo in patients with type 2 diabetes. Improvement in dyslipidemia will be evaluated. The study comprises a 2-week screening period, 4-week placebo run-in, a 12-week randomized, double blind, parallel group, multi-center, placebo-controlled treatment period, and a 3-week follow-up.
Interventions
DRUGTesaglitazar
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Provision of a written informed consent * Men or women who are \>=18 years of age * Female patients: postmenopausal, hysterectomized * Diagnosed with type 2 diabetes * Treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral anti-diabetic 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-response relationship of tesaglitazar in subjects with type 2 diabetes by the assessment of the effects of each of four doses of tesaglitazar (0.25, 0.5, 0.75 and 1 mg) to placebo with respect to fasting plasma glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, total cholesterol apolipoproteins (Apo) (Apo A-I, Apo B and Apo CIII), and f | — |
| Glucose and insulin values during an oral glucose tolerance test | — |
| Effects on the reduction of insulin and glycosylated hemoglobin A1c levels | — |
| Effects on the proportion of fasting plasma glucose responders | — |
| Changes in the following variables from baseline to the end of the randomized treatment period: | — |
| Effects on the changes from baseline in weight and waist/hip ratio | — |
| Evaluate the pharmacokinetics of tesaglitazar | — |
| Assess the safety and tolerability of tesaglitazar compared to placebo | — |
| Effects on the proportion of high-density lipoprotein cholesterol responders | — |
Countries
Japan
Outcome results
None listed