Korean AMADEUS Study

NCT01239849 | Unknown Phase 4 DMC

• 1 other identifier: SKimlipid
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Diabetes Mellitus, Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects in the total LDL cholesterol group achieving their LDL cholesterol target after 8 weeks of treatment.

  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.

  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.

  8 weeks

• 3. Percentage of subjects who achieved LDL cholesterol target with no titration of atorvastatin and after one step titration of atorvastatin

  8 weeks

• 4. Change and percent change from baseline to 4 and 8 weeks of treatment for small dense LDL cholesterol, adiponectin, hs-CRP

  8 weeks

• 5. Safety of atorvastatin through laboratory assessment, physical examination, vital signs, and adverse events.

  8 weeks

Interventions

Atorvastatin, 10mg, 20mg, 40mg DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Catholic University of Korea: lead
• Pfizer: collaborator

Study Sites (1)

Sung Rae Kim

Bucheon-si, Kyeongki, 420-717, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 24843697 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• SUNG RAE KIM, A. Professor

  Bucheon St. Mary Hospital, The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SUNG RAE KIM, A. Professor

CONTACT

+82-32-340-2025; kimsungrae@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: November 15, 2010

Record last verified: 2009-02

Locations

KR (1)