Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus
NCT ID: NCT01030679
Last Updated: 2009-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
214 participants
INTERVENTIONAL
2007-07-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CKD-501 0.5mg
CKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 1mg
CKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 2mg
CKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
Placebo
Placebo
orally, 1 tablet once daily for 8 weeks
Interventions
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CKD-501 0.5mg
0.5 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 1mg
1 mg/tablet, orally, 1 tablet once daily for 8 weeks
CKD-501 2mg
2 mg/tablet, orally, 1 tablet once daily for 8 weeks
Placebo
orally, 1 tablet once daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fasting Plasma Glucose(FPG)≥ 126 and ≤ 270
* HbA1c between 7 and 11%
* Body mass index (BMI) in the range 21-40
* The patients who has been taking oral hypoglycemic agent or diet therapy before minimum 1 month
* Agreement with written informed consent
Exclusion Criteria
* Treatment with insulin(over 1month) within 3 months
* Fasting Plasma Glucose level is over 270 mg/dl
* Triglyceride level is 500 mg/dl and over
* Uncontrollable hypertension
* History of myocardial infarction, heart failure, cerebral infarction, hematencephalon or unstable angina within 6 months
* Severe hepatic dysfunction: AST, ALT, Total bilirubin, ALP level over or equal to 3 times as high as upper normal limit(UNL)
* Severe renal dysfunction: Renal failure or serum creatinine greater than 30% normal limit
* Needs treatment for acute disease, uncontrolled other diseae or diabetic complications
* In treatment concomitant drug having severe risk drug interaction with investigational drug
* History of cancer within 5 years
* History of drug abuse or alcoholism
* Hepatitis B Antigen(HBsAg) test is positive
* Treatment systemic or inhalant corticosteroids within 1 month prior to Screening
* Patient who have experience such as hypersensitivity reaction, serious adverse event or no effect by treatment with glitazones
* Fertile women who not practice contraception with appropriate methods Pregnant women or nursing mothers
* Has a contraindication to treatment investigational drug from the medical and psychogenic side
* Participated in other trial within 4 weeks Participating in other trial at present
* An impossible one who participates in clinical trial by legal or investigator's decision
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Chong Kun Dang
Principal Investigators
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Dongseop Choi, MD.,Ph.D.
Role: STUDY_CHAIR
The Korea University Anam Hospital
Locations
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The Inje University Medical Center
Busan, , South Korea
The Yeungnam University Hospital
Daegu, , South Korea
The Chtholic University of Korea Uijeongbu St. Mary's Hospital
Gyeonggi-do, , South Korea
The Seoul National Univertisy Bundang Hospital
Gyeonggi-do, , South Korea
The Wonju Christian Hospital
Kangwon-Do, , South Korea
The Inje University Sanggye-Paik Hospital
Seoul, , South Korea
The Korea University Anam Hospital
Seoul, , South Korea
The Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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19DM05L
Identifier Type: -
Identifier Source: org_study_id