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

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ClinicalTrials.gov Identifier: NCT00255645
Recruitment Status : Terminated (The development program has been terminated)
First Posted : November 21, 2005
Last Update Posted : March 17, 2008
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Brief Summary:
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 or disease Phase
Type 2 Diabetes Phase 3

Study Type : Observational
Estimated Enrollment : 4500 participants
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.
Study Start Date : September 2005
Study Completion Date : December 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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

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Sponsors and Collaborators
Study Director: AstrasZeneca Galida Medical Science Director, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00255645     History of Changes
Other Study ID Numbers: D6160C00056
EudraCT No 2005-001373-97
First Posted: November 21, 2005    Key Record Dates
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