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GALLANT 5 Tesaglitazar Versus Metformin

NCT00214591 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2010-11-19

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

GALIDA

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Galida Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States
  • Finland
  • Germany
  • Israel
  • Netherlands
  • Norway
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00214591 on ClinicalTrials.gov