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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 18, 2005

Last Updated Date

March 14, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00255645 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Biospecimen

Sampling Method

Study Population

Condition ^ICMJE

Type 2 Diabetes

Intervention ^ICMJE

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

4500

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Estonia, Finland, Former Serbia and Montenegro, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, Vietnam

Administrative Information

NCT Number ^ICMJE

NCT00255645

Other Study ID Numbers ^ICMJE

D6160C00056, EudraCT No 2005-001373-97

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstrasZeneca Galida Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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