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

HDL Cholesterol Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Balanced, Three-Way Crossover Study to Evaluate the Efficacy of Simvastatin Therapy in Elevating HDL-C Levels in Patients With Type 2 Diabetic Dyslipidemia and Low HDL-C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00389896
• Other study ID #: 0733-216
• Secondary ID: 2006_536
• Status: Completed
• Phase: Phase 3
• Start date: July 26, 2001
• Est. completion date: October 4, 2002

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 4, 2002
• Est. primary completion date: October 4, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• HDL Cholesterol

Intervention

Drug:
• MK0733 / Duration of Treatment: 18 Weeks

• Comparator: placebo (unspecified) / Duration of Treatment: 18 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (2)

Miller M, Dobs A, Yuan Z, Battisti WP, Borisute H, Palmisano J. Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. Curr Med Res Opin. 2004 Jul;20(7):1087-94. — View Citation

Miller M, Dobs A, Yuan Z, Battisti WP, Palmisano J. The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: a SILHOUETTE trial sub-study. Curr Med Res Opin. 2006 Feb;22(2):343-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-C raising effects after 6 weeks		6 weeks
Secondary	Effect on other lipids and lipoproteins at 6 weeks		6 weeks