GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Fenofibrate; Metformin

Criteria

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