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

This study has been terminated.
(The development program has been terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00255645
First Posted: November 21, 2005
Last Update Posted: March 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255645


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

ClinicalTrials.gov Identifier: NCT00255645     History of Changes
Other Study ID Numbers: D6160C00056
EudraCT No 2005-001373-97
First Submitted: November 18, 2005
First Posted: November 21, 2005
Last Update Posted: March 17, 2008
Last Verified: March 2008

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