drugset / Trial / NCT00214591

GALLANT 5 Tesaglitazar Versus Metformin

NCT00214591

Phase 3 Terminated 580 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (metformin) study of tesaglitazar in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. The study comprises a 6 week placebo single blind run in period followed by a 52-week a double blind treatment period and a 3-week follow-up period. Tesaglitazar and metformin will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Timeline

Start
2004-08
Primary completion
2006-12
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tesaglitazar Small molecule