Therapeutic Exploratory Study of CWP-0403

A Prospective, Randomized, Double Blinded, Multicenter and Therapeutic Exploratory Study to Comparatively Assess Efficacy and Safety of CWP-0403 in Type 2 Diabetes Patients Who Are Insufficiently Controlled by Diet and Exercise.

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 patients who are insufficiently controlled by diet and exercise in comparison to placebo.

Inclusion Criteria:

• 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 Criteria:

• 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