Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00551876
Collaborator
(none)
214
13

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the addition of ezetimibe 10 mg daily to ongoing 20 mg simvastatin daily will reduce LDL Cholesterol to a greater extent than increasing the dose of simvastatin to 40 mg daily in Type 2 diabetics treated with Thiazolidinediones (TZD).

Condition or Disease Intervention/Treatment Phase
  • Drug: MK0653, ezetimibe / Duration of Treatment: 30 Weeks
  • Drug: Comparator : ezetimibe (+) simvastatin / Duration of Treatment: 30 Weeks
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
214 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Parallel, Multicenter Study to Evaluate the Efficacy and Safety of Simvastatin Monotherapy Compared With Simvastatin Plus Ezetimibe (SCH 58235) in Type 2 Diabetic Patients Treated With Thiazolidinediones
Study Start Date :
Dec 1, 2001
Actual Primary Completion Date :
Jan 1, 2003
Actual Study Completion Date :
Jan 1, 2003

Outcome Measures

Primary Outcome Measures

  1. Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements [6 & 12 Weeks]

Secondary Outcome Measures

  1. Well tolerated in patients in Diabetic patients [30 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Men or women age between 30 and 75 with Type 2 diabetes mellitus who are treated with pioglitazone or rosiglitazone

  • Additionally, patients must have an LDL-C >100 mg/dL at Visit 1 or prior to initiation of statin therapy

Exclusion Criteria:
  • Patients taking sliding scale insulin, selected lipid lowering medications, oral anticoagulants and cyclical sex hormones

  • Patients with heart disease, kidney disease, liver disease, uncontrolled high blood pressure, and insulin dependent diabetes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00551876
Other Study ID Numbers:
  • 0653-021
  • MK0653-021
  • 2006_554
First Posted:
Oct 31, 2007
Last Update Posted:
Feb 18, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 18, 2022