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GALLANT 7 Tesaglitazar Add-on to Sulphonylurea

NCT00251940 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 555

Last updated 2008-03-17

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 sulphonylurea in patients with type 2 diabetes, not adequately controlled on optimized sulphonylurea 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 0.5 or 1 mg

DRUG

Glibenclamide 2.5, 5, 10 or 15 mg

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
  • France
  • Israel
  • Norway
  • Philippines
  • South Africa
  • South Korea
  • Spain
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

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 NCT00251940 on ClinicalTrials.gov