A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)

Phase 3

Completed

• Conditions: HDL Cholesterol

• Registration Number: NCT00389896
• Lead Sponsor: Organon and Co

Brief Summary

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07-26
• Primary Completion: 2002-10-04
• Study Completion: 2002-10-04
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient has stable Type 2 diabetes mellitus at Visit 1.
• Patient meets screening criteria based on Visit 1 lab tests

Exclusion Criteria

• Patient is pregnant, breastfeeding, or at risk of becoming pregnant
• Patient has heart disease, uncontrolled high blood pressure, or other significant disease
• Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
HDL-C raising effects after 6 weeks	6 weeks

Secondary Outcome Measures

Name	Time	Method
Effect on other lipids and lipoproteins at 6 weeks	6 weeks