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

This study has been terminated.

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255645

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 III

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

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

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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009