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Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes

NCT01185236 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2010-08-19

No results posted yet for this study

Summary

A single center, open label, randomized, clinical trial comparing ApoB/ApoA ratio of Vytorin 10/20mg vs atorvastatin 20mg treatment.

DM2 patients will be screened for inclusion criteria. Patients (n=66 in each arm) will be randomized to either Ezetimibe/simvastatin 10/20mg or atorvastatin 20mg after 4 week washout or TLC period. Primary and secondary endpoints will be assessed at week 12.

Primary endpoint:

1\) change of ApoB/ApoA ratio at week 12.

Secondary endpoint:

1. Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
2. Change of HbA1C at week 12.
3. Change of HOMA index at week 12

\- HOMA =\[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)\] / 22.5
4. Change of hsCRP at week 12
5. Safety assessment

Hypotheses:

* Three months treatment of Vytorin 10/20mg will be superior to atorvastatin 20mg in ApoB/ApoA ratio.
* In DM patients, Ezetimibe/Simvastatin Combination will be well-tolerated.

Conditions

  • Type 2 Diabetes Mellitus Without Insulin Treatment

Interventions

DRUG

simvastatin/ezetimibe

simvastatin/ezetimibe 10/20mg once daily for 12weeks

DRUG

atorvastatin 20mg

atorvastatin 20mg once daily for 12weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01185236 on ClinicalTrials.gov