Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects

Completed

• Conditions: Type 2 Diabetes Mellitus; CV Risk

• Registration Number: NCT00648284
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The primary objective of this study is to assess the total CV risk in patients with type 2 diabetes and also to assess the impact of rosiglitazone in the total CV risk and the parameters of metabolic syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-01
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-13
• Last Update Posted: 2008-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Not provided

Exclusion Criteria

• Patients with ALT > 2.5x the normal value
• With heart failure symptoms
• With diagnosis of angina pectoris or stable angina demanding continuous treatment with nitrates
• With recent myocardial infarction (<6 months)
• With severe renal disfunction
• Pregnant or lactating or planned to be pregnant during the study
• Under investigational drug treatment
• Alcoholic or drug abuser

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified