drugset / Trial / NCT00255541

GALLANT 4 Tesaglitazar vs. Glibenclamide

NCT00255541

Phase 3 Terminated 580 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a 52-week randomized, double-blind, parallel-group, multi-center, active-controlled (glibenclamide) 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 double blind treatment period and a 3-week follow-up period. Tesaglitazar and glibenclamide will be titrated to optimal effect or highest tolerable dose during the first 12 weeks.

Timeline

Start
2004-09
Primary completion
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule
Subject Tesaglitazar Small molecule