NCT01185236

Brief 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:

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 19, 2010

Status Verified

August 1, 2010

Enrollment Period

11 months

First QC Date

August 18, 2010

Last Update Submit

August 18, 2010

Conditions

Type 2 Diabetes Mellitus Without Insulin Treatment

Keywords

Diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • change of ApoB/ApoA1

    change of ApoB/ApoA1

    after 12 weeks' treatment

Secondary Outcomes (5)

  • change of lipid profile

    12weeks

  • change of HbA1c

    12weeks

  • change of HOMA index

    12weeks

  • change of hsCRP

    12weeks

  • safety

    during 12weeks of treatment

Study Arms (2)

simvastatin/ezetimibe (vytorin) group

EXPERIMENTAL

vytorin 10/20mg po once daily for 12weeks

Drug: simvastatin/ezetimibe

atorvastatin group

ACTIVE COMPARATOR

atorvastatin 20mg po once daily for 12weeks

Drug: atorvastatin 20mg

Interventions

simvastatin/ezetimibeDRUG

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

simvastatin/ezetimibe (vytorin) group
atorvastatin 20mgDRUG

atorvastatin 20mg once daily for 12weeks

atorvastatin group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 DM
  • Hypercholesterolemia (baseline screening LDL-C \> 100 mg/dL)
  • In case of medication, stable doses of oral hypoglycemic agents for at least three months
  • HbA1c \<8.5%
  • Age: 20-80

You may not qualify if:

  • Chronic renal failure: creatinine \> 3.0 mg/dL
  • Serious liver disease (\> x3 LFT UNL)
  • Congestive heart failure
  • Stroke or MI/coronary intervention during the preceding 3 months.
  • CK \> x 2.5 UNL
  • Unstable hypo/hyperthyroidism
  • Pregnant/lactating woman, or woman intending to become pregnant
  • Subject with any clinically significant condition or situation, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, 110744, South Korea

Location

Related Publications (1)

  • Lee JH, Kang HJ, Kim HS, Sohn DW, Oh BH, Park YB. Effects of ezetimibe/simvastatin 10/20 mg vs. atorvastatin 20 mg on apolipoprotein B/apolipoprotein A1 in Korean patients with type 2 diabetes mellitus: results of a randomized controlled trial. Am J Cardiovasc Drugs. 2013 Oct;13(5):343-51. doi: 10.1007/s40256-013-0031-6.

    PMID: 23728830DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Ezetimibe, Simvastatin Drug CombinationAtorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

SimvastatinLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEzetimibeAzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Hyun-Jae Kang

CONTACT

82-2-2072-2279nowkang@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2010

First Posted

August 19, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 19, 2010

Record last verified: 2010-08

Locations

KR(1)