Overview

GALLANT 14 Tesaglitazar vs. Metformin and Fenofibrate

Status:
Terminated
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
AstraZeneca
Treatments:
Fenofibrate
Metformin