Diabetes Mellitus, HypercholessterolemiaPhase 4NCT01239849
Korean AMADEUS Study
A Phase 4 study testing Atorvastatin, 10mg, 20mg, 40mg in people with Diabetes Mellitus, Hypercholessterolemia, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. \& NCEP ATP III update. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hypercholessterolemia
- What is being tested?
- Atorvastatin, 10mg, 20mg, 40mg
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Korean Diabetes Patients
- Is ≥ 18 and ≤ 80 years olds
- Has diagnosis of dyslipidemia
- Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl
- Has triglyceride level ≤ 600 mg/dl
- Has HbA1c ≤ 12%
Show all 9Show fewer
- If female, is postmenopausal, surgically sterilized, or using a reliable methods of birth control considered suitable by the investigator
- Can discontinue all current antilipidemic medication for the 4 week washout period
- Has provided written informed consent prior to the initiation of any study procedure
Who cannot join
- Is pregnant or lactating
- Abuse alcohol and/or any other drug
- Uncontrolled diabetes ( HbA1c > 12% )
- Has impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT,SGOT) or aspartate aminotransferase (AST, SGOT) ≥ 2times the upper limit of normal at baseline.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Sung Rae Kim
Bucheon-si, Kyeongki, 420-717
SUNG RAE KIM, A. Professor, +82-32-340-2025, kimsungrae@catholic.ac.kr
JAE HYUNG CHO, Professor
About this study
Official title: A Multicenter, Eight Weeks Treatment, Single Step Titration, Open Label Study Assessing the Percentage of Korean Diabetic Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Dose 10mg, 20mg, 40mg
Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. \& NCEP ATP III update. However, there are large unmet medical needs for DM patients who don't reach their target LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest dose of statin and then titrate to the goal. Thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for DM patients. Besides that, we are going to find out preliminary data about other markers change; small dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain the impact of triglyceride. Adiponectin is another good marker related with obesity and metabolic syndrome.
- Conditions
- Diabetes Mellitus, Hypercholessterolemia
- Being tested
- Atorvastatin, 10mg, 20mg, 40mg
- Keywords
- Diabetes Mellitus, Hypercholesterolemia
- Medical subject headings
- Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin, 10mg, 20mg, 40mgDrug
If initial LDL cholesterol between 100~ 129mg/dl then starting dose of Atorvastatin is 10mg, 130~159 mg/dl is 20 mg, 160~220mg/dl is 40mg.
After 4weeks treatment, if LDL cholesterol is below 100mg/dl then continue starting dose and if not reach below 100mg/dl then titration double dose.
After 4 weeks treatment, recheck the LDL cholesterol
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment.
Measured: 8 weeks
Secondary outcomes (5)
1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment.
Measured: 8 weeks
2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL cholesterol, HDL cholesterol, non-HDL cholesterol, LDL cholesterol/HDL cholesterol ratio, Total cholesterol, Triglyceride subjects in the total group.
Measured: 8 weeks
3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin
Measured: 8 weeks
4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP
Measured: 8 weeks
5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startFeb 2009
- Primary completionDec 2010 (estimated)
- Study completionFeb 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 Diabetes Mellitus, HypercholessterolemiaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- SUNG RAE KIM, A. Professor, Principal investigator, Bucheon St. Mary Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239849
- Sponsor's protocol ID
- SKimlipid
- Status last verified
- Feb 2009
- First submitted
- 10 Nov 2010
- Last updated
- 15 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Son JW, Kim DJ, Lee CB, Oh S, Song KH, Jung CH, Mok JO, Kim JH, Moon MK, Choi KM, Cho JH, Choi SH, Kim SK, Park KS, Kim HS, Kim IJ, Kim YI, Kim HJ, Kim SY, Kim S. Effects of patient-tailored atorvastatin therapy on ameliorating the levels of atherogenic lipids and inflammation beyond lowering low-density lipoprotein cholesterol in patients with type 2 diabetes. J Diabetes Investig. 2013 Sep 13;4(5):466-74. doi: 10.1111/jdi.12074. Epub 2013 Mar 26.
PubMed 24843697
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Eight Weeks Treatment, Single Step Titration, Open Label Study Assessing the Percentage of Korean Diabetic Dyslipidemic Patients Achieving LDL Cholesterol Target With Atorvastatin Starting Dose 10mg, 20mg, 40mg
- ClinicalTrials.gov ID
- NCT01239849
- Acronym / sponsor ID
- SKimlipid
- Conditions
- Diabetes Mellitus, Hypercholessterolemia
- Keywords
- Diabetes Mellitus, Hypercholesterolemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 11 Nov 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.
Because Diabetes Mellitus is one of the major risk factors for CV disease and lots of related evidences have been published including CARDS study that showed definite benefit of statin treatment in DM patients and influenced ADA guideline. \& NCEP ATP III update. However, there are large unmet medical needs for DM patients who don't reach their target LDL-C level defined NCEPT ATP III update because of physicians usually start with the lowest dose of statin and then titrate to the goal. Thus, we are curious about changing our prescription pattern into more tailored way; selecting starting dose based on the individual risk factors and concomitant status will impact the goal achieving rate for DM patients. Besides that, we are going to find out preliminary data about other markers change; small dense LDL and adiponectine;. Small dense LDL-C is more inflammatory and atherogenic LDL-C that may explain the impact of triglyceride. Adiponectin is another good marker related with obesity and metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Korean Diabetes Patients
- Is ≥ 18 and ≤ 80 years olds
- Has diagnosis of dyslipidemia
- Has 100 mg/dl ≤ LDL cholesterol ≤ 220 mg/dl
- Has triglyceride level ≤ 600 mg/dl
Key exclusion criteria (4 listed)
- Is pregnant or lactating
- Abuse alcohol and/or any other drug
- Uncontrolled diabetes ( HbA1c > 12% )
- Has impaired hepatic function, as shown by but not limited to alanine aminotransferase (ALT,SGOT) or aspartate aminotransferase (AST, SGOT) ≥ 2times the upper limit of normal at baseline.
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 |
|---|---|---|
| Atorvastatin, 10mg, 20mg, 40mgIf initial LDL cholesterol between 100~ 129mg/dl then starting dose of Atorvastatin is 10mg, 130~159 mg/dl is 20 mg, 160~220mg/dl is 40mg. After 4weeks treatment, if LDL cholesterol is below 100mg/dl then continue starting dose and if not reach below 100mg/dl then titration double dose. After 4 weeks treatment, recheck the LDL cholesterol | Drug | – |
Primary outcome
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment.
Time frame: 8 weeks
5 secondary outcomes
1. Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 4 weeks of treatment.
Time frame: 8 weeks
2. Change and percent change from baseline to 4 and 8 weeks of treatment for LDL cholesterol, HDL cholesterol, non-HDL cholesterol, LDL cholesterol/HDL cholesterol ratio, Total cholesterol, Triglyceride subjects in the total group.
Time frame: 8 weeks
3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin
Time frame: 8 weeks
4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP
Time frame: 8 weeks
5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2010.
- Derived from this study: PubMed 24843697Son JW, Kim DJ, Lee CB, Oh S, Song KH, Jung CH, Mok JO, Kim JH, Moon MK, Choi KM, Cho JH, Choi SH, Kim SK, Park KS, Kim HS, Kim IJ, Kim YI, Kim HJ, Kim SY, Kim S. Effects of patient-tailored atorvastatin therapy on ameliorating the levels of atherogenic lipids and inflammation beyond lowering low-density lipoprotein cholesterol in patients with type 2 diabetes. J Diabetes Investig. 2013 Sep 13;4(5):466-74. doi: 10.1111/jdi.12074. Epub 2013 Mar 26.
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.
SUNG RAE KIM, A. Professor principal investigator
Bucheon St. Mary Hospital, The Catholic University of Korea
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 Atorvastatin, 10mg, 20mg, 40mg in people with Diabetes Mellitus, Hypercholessterolemia, run by The Catholic University of Korea 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 9 inclusion and 4 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 15 Nov 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 SUNG RAE KIM, A. Professor (+82-32-340-2025, kimsungrae@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment. (time frame: 8 weeks). 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 NCT01239849, 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 15 Nov 2010; AzTrials last refreshed its copy on 29 Oct 2026.