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

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.”

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.

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

AstrasZeneca Galida Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00255645

Study ID Number: D6160C00056

ClinicalTrials.gov Identifier: NCT00255645

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency