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

Stopped early

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00255645

Run by

AstraZeneca

People needed

4500

Starts

2005-09-01

Expected to finish

2006-12-01

Last updated by the study team

2008-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Received open-label treatment with tesaglitazar (since this is a post-treatment study)

Where it is running

• Research Site — Columbiana, Alabama, United States
• Research Site — Mobile, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Searcy, Arizona, United States
• Research Site — Sierra Vista, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Carlisle, Arkansas, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Sherwood, Arkansas, United States
• Research Site — Anaheim, California, United States
• Research Site — Carmichael, California, United States
• Research Site — Chula Vista, California, United States
• Research Site — Elk Grove, California, United States
• Research Site — Encinitas, California, United States
• Research Site — Encino, California, United States
• Research Site — Escondido, California, United States
• Research Site — Fresno, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — Huntington Beach, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Loma Linda, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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