Type 2 Diabetes Mellitus Without Insulin TreatmentPhase 4NCT01185236
Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
A Phase 4 study testing simvastatin/ezetimibe and atorvastatin 20mg in people with Type 2 Diabetes Mellitus Without Insulin Treatment, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus Without Insulin Treatment
- What is being tested?
- simvastatin/ezetimibe and atorvastatin 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national university hospital
Seoul, 110744
Hyun-Jae Kang
About this study
Official title: A Single Center, Open Label, Randomized Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
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.
Read more
Primary endpoint:
- change of ApoB/ApoA ratio at week 12.
Secondary endpoint:
- Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
- Change of HbA1C at week 12.
- Change of HOMA index at week 12
- HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- Change of hsCRP at week 12
- 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.
- Being tested
- simvastatin/ezetimibe, atorvastatin 20mg
- Keywords
- Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatin/ezetimibeDrug
simvastatin/ezetimibe 10/20mg once daily for 12weeks
atorvastatin 20mgDrug
atorvastatin 20mg once daily for 12weeks
| Study group | Role | What they receive |
|---|---|---|
| simvastatin/ezetimibe (vytorin) group | Experimental | vytorin 10/20mg po once daily for 12weeks Receives: Drug: simvastatin/ezetimibe |
| atorvastatin group | Active comparator | atorvastatin 20mg po once daily for 12weeks Receives: Drug: atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of ApoB/ApoA1
change of ApoB/ApoA1
Measured: after 12 weeks' treatment
Secondary outcomes (5)
change of lipid profile
change of total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglyceride, and APO B48
Measured: 12weeks
change of HbA1c
change of HbA1c
Measured: 12weeks
change of HOMA index
HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
Measured: 12weeks
change of hsCRP
change of hsCRP
Measured: 12weeks
safety
CK elevation, Liver funtion test abnormality, and muscle realted adverse reactions and symptoms
Measured: during 12weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus Without Insulin TreatmentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185236
- Sponsor's protocol ID
- H-1007-100-324
- Status last verified
- Aug 2010
- First submitted
- 18 Aug 2010
- Last updated
- 19 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23728830
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open Label, Randomized Study to Compare the Effect of Vytorin (Simvastatin/Ezetimibe) 10/20mg Versus Atorvastatin 20mg on ApoB/ApoA1 Ratio in Subjects With Diabetes
- ClinicalTrials.gov ID
- NCT01185236
- Acronym / sponsor ID
- H-1007-100-324
- Keywords
- Diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- change of ApoB/ApoA ratio at week 12.
Secondary endpoint:
- Change of lipid parameters (TC, LDL-C, HDL-C, TG, apoB 48) at week 12.
- Change of HbA1C at week 12.
- Change of HOMA index at week 12
- HOMA =[Fasting insulin (mIU/L) × Fasting glucose (mmol/L)] / 22.5
- Change of hsCRP at week 12
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin/ezetimibe (vytorin) group | Experimental | Drug: simvastatin/ezetimibevytorin 10/20mg po once daily for 12weeks |
| atorvastatin group | Active comparator | Drug: atorvastatin 20mgatorvastatin 20mg po once daily for 12weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simvastatin/ezetimibesimvastatin/ezetimibe 10/20mg once daily for 12weeks | Drug | simvastatin/ezetimibe (vytorin) group |
| atorvastatin 20mgatorvastatin 20mg once daily for 12weeks | Drug | atorvastatin group |
Primary outcome
change of ApoB/ApoA1
Time frame: after 12 weeks' treatment
change of ApoB/ApoA1
5 secondary outcomes
change of lipid profile
Time frame: 12weeks
change of HbA1c
Time frame: 12weeks
change of HOMA index
Time frame: 12weeks
change of hsCRP
Time frame: 12weeks
safety
Time frame: during 12weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2010.
- Derived from this study: PubMed 23728830Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing simvastatin/ezetimibe and atorvastatin 20mg in people with Type 2 Diabetes Mellitus Without Insulin Treatment, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Jae Kang (82-2-2072-2279, nowkang@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of ApoB/ApoA1 (time frame: after 12 weeks' treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01185236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2010.