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

Terminated

• Conditions: Type 2 Diabetes

• Registration Number: NCT00255645
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-18
• Study First Submitted QC: 2005-11-18
• Study First Posted: 2005-11-21
• Study Completion: 2006-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-14
• Last Update Posted: 2008-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam