Status:
COMPLETED
Therapeutic Exploratory Study of CWP-0403
Lead Sponsor:
JW Pharmaceutical
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-75 years
Phase:
PHASE2
Brief Summary
Objective of the trial is to assess dose-dependency, efficacy and safety and to estimate optimum dosage for confirmatory study of CWP-0403 50mg, 100mg given twice daily for 12 weeks to type 2 diabetes...
Eligibility Criteria
Inclusion
- Age of≥25 and \<75 with typeⅡ DM patients
- 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
- TypeⅠDM, Gestational diabetes.
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00888719
Start Date
February 1 2009
End Date
April 1 2010
Last Update
November 5 2010
Active Locations (10)
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1
Chonbuk National University Hospital
Seoul, South Korea
2
Ewha Womans University Mokdong Hospital
Seoul, South Korea
3
Gachon Medical School Gil Medical Center
Seoul, South Korea
4
Inha University Hospital
Seoul, South Korea