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GALLANT 8 Tesaglitazar Add-on to Metformin

NCT00251953 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2009-04-22

No results posted yet for this study

Summary

This is a 24-week randomized double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 mg and 1 mg) given as add-on therapy to metformin in patients with type 2 diabetes, not adequately controlled on optimized metformin treatment and on diet/lifestyle advice during the titration and run-in period. The study comprises a 2-week enrollment period, 6 week placebo metformin titration period, 2-week single-blind run-in period, followed by a 24-week double blind treatment period and a 3-week follow-up period

Conditions

Interventions

DRUG

Tesaglitazar

DRUG

Metformin

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
2004-07-31
Completion
2006-03-31

Countries

  • Australia
  • Canada
  • Finland
  • Germany
  • India
  • Italy
  • Malaysia
  • Philippines
  • Singapore
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00251953 on ClinicalTrials.gov