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
145 participants
INTERVENTIONAL
2009-02-28
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CWP-0403 50mg
CWP-0403 50mg
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
CWP-0403 100mg
CWP-0403 100mg
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
placebo
placebo
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
Twice a day, 1 tablet at a time for 12 weeks
Interventions
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CWP-0403 100mg
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
placebo
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
Twice a day, 1 tablet at a time for 12 weeks
CWP-0403 50mg
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients whose level of HbA1c is over 7.0% and less than 10% within 4weeks of screening registration
* In spite of dietary and exercise treatment over 8weeks, the level of HbA1c is over 6.5% and less than 10%.
* BMI between 20kg/㎡ and 40kg/㎡
* Out patients
* patients who agree the trial participation with written informed consent
Exclusion Criteria
* Patients who are being treated with insulin
* Fasting glucose level over 250mg/dL
* Patients who are not compliant with dietary and exercise treatment during 8 weeks of screening period. (Evaluated "Bad" and worse)
* Severe hepatic dysfunctions (i.e.: uncompensated hepatic cirrhosis)or AST or ALT level over 2.5times as high as UNL on screening visit.
* Severe renal dysfunctions (i.e.: renal failure) or serum creatinine level over 1.5mg/dl
* Severe cardiac dysfunction(i.e.: heart failure ) or history of myocardial infarction within 6months of screening
* Chronic pulmonary disease or pulmonary infarction
* Pancreatitis patients
* Patients who are being treated for life threatening disease such as cancer, severe trauma or infection.
* Uncontrollable diabetic complications(neuropathy, retinopathy, nephrosis)
* Severe ketosis or experience of diabetic coma
* Intestinal disease affecting digestion or absorption or history of GI dissection surgery except for appendectomy.
* Pregnant, expecting to be pregnant or nursing female
* Excessive alcohol consumption (Over 80g of alcohol/day: Over 1 bottle of 360ml Soju/day)
* Participants of other clinical trials within 3 months of screening
* Patients medicated with following non-concomitant medications Insulins or oral antidiabetics Oral (for more than 1 week) or IV corticosteroids (External and inhaled corticosteroids excluded) appetite suppressant exenatide or other GLP-1 analogues Other medications in development
* Hypersensitive or intolerance to DPP4 inhibitory
* patients who are decided to be inappropriate for this trial subject by the investigators
25 Years
75 Years
ALL
No
Sponsors
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JW Pharmaceutical
INDUSTRY
Responsible Party
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ChoongWae Pharma Corporation
Principal Investigators
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KunHo Yoon
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
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Chonbuk National University Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Gachon Medical School Gil Medical Center
Seoul, , South Korea
Inha University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyungpook National University Hospital
Seoul, , South Korea
Seoul National University Bundang Hopital
Seoul, , South Korea
The Catholic University of Korea, Holly Family Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CWP-SKD-201
Identifier Type: -
Identifier Source: org_study_id