G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

This study has been terminated.
(The development program has been terminated)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255645
First received: November 18, 2005
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.


Condition Phase
Type 2 Diabetes
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Estimated Enrollment: 4500
Study Start Date: September 2005
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of a written informed consent
  • Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Exclusion Criteria:

  • Received open-label treatment with tesaglitazar (since this is a post-treatment study)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255645

  Show 543 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstrasZeneca Galida Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00255645     History of Changes
Other Study ID Numbers: D6160C00056, EudraCT No 2005-001373-97
Study First Received: November 18, 2005
Last Updated: March 14, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014