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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00389896

Enrollment

150

Registered

2006-10-19

Start date

2001-07-26

Completion date

2002-10-04

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HDL Cholesterol

Brief summary

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

Interventions

DRUGMK0733 / Duration of Treatment: 18 Weeks

DRUGComparator: placebo (unspecified) / Duration of Treatment: 18 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HDL-C raising effects after 6 weeks	6 weeks

Secondary

Measure	Time frame
Effect on other lipids and lipoproteins at 6 weeks	6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026