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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014