Type 2 Diabetes
Conditions
Brief summary
This is a 16-week randomized, double-blind, parallel-group, multi-center, placebo- and active- (metformin 1.5 g) controlled study of tesaglitazar (1 mg) in patients with type 2 diabetes. After a 1-week enrollment period, a 3 week placebo single blind run in period and 1-week placebo single-blind baseline measurement period, the patients will be given the investigational product for 16 weeks in a double blind fashion. Metformin will be titrated up during the first 3 weeks of the double-blind period. The total study duration, including enrollment, run-in, randomized treatment and follow-up, is 29 weeks.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of a written informed consent * Men or women who are 30-70 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole-body insulin sensitivity by assessing the M value during high (80 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory efficacy variables (lipids, inflammatory marker and adipose tissue hormones) | — |
| Safety and tolerability of tesaglitazar in patients with type 2 diabetes. | — |
| Hepatic and peripheral insulin sensitivity by assessing the M value during low (20 mU/m2/min) insulin level euglycemic hyperinsulinemic clamp. | — |
| Basal hepatic glucose output measured by dideuterated glucose in the fasting state and during low insulin level clamp. | — |
| Waist and hip circumference | — |
| Calculated insulin secretion | — |
| Liver oxidation after a mixed meal | — |
| Energy expenditure and substrate metabolism by indirect calorimetry | — |
| Body composition using DXA-scan, abdominal fat distribution using magnetic resonance imaging, liver fat and muscle fat content using magnetic resonance spectroscopy | — |
| Plasma profile of glucose, insulin and lipids after a mixed meal | — |
Countries
Finland, Italy, United Kingdom
Outcome results
None listed