Type 2 Diabetes
Conditions
Brief summary
This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period
Interventions
DRUGTesaglitazar
DRUGMetformin
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 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 |
|---|---|
| Absolute change from baseline to end of randomized treatment period in glycosylated hemoglobin A1c (HbA1c) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Changes in the following variables from baseline to the end of the randomized treatment period: | — |
| 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 | — |
| Fibrinogen | — |
Countries
Australia, Canada, Finland, Germany, India, Italy, Malaysia, Philippines, Singapore, Sweden, United Kingdom
Outcome results
None listed