Study Evaluating the Efficacy and Safety of Simvastatin Alone Compared With Simvastatin Plus Ezetimibe in Type 2 Diabetic Patients (0653-021)(COMPLETED)
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
3 other identifiers
interventional
214
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Dec 2001
Shorter than P25 for phase_3 diabetes-mellitus-type-2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 29, 2007
CompletedFirst Posted
Study publicly available on registry
October 31, 2007
CompletedAugust 15, 2024
February 1, 2022
1.1 years
October 29, 2007
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in fasting LDL-C from baseline to the average of the Week 6/Week 12 measurements
6 & 12 Weeks
Secondary Outcomes (1)
Well tolerated in patients in Diabetic patients
30 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
Gaudiani LM, Lewin A, Meneghini L, Perevozskaya I, Plotkin D, Mitchel Y, Shah S. Efficacy and safety of ezetimibe co-administered with simvastatin in thiazolidinedione-treated type 2 diabetic patients. Diabetes Obes Metab. 2005 Jan;7(1):88-97. doi: 10.1111/j.1463-1326.2004.00420.x.
PMID: 15642080BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2007
First Posted
October 31, 2007
Study Start
December 1, 2001
Primary Completion
January 1, 2003
Study Completion
January 1, 2003
Last Updated
August 15, 2024
Record last verified: 2022-02