Therapeutic Exploratory Study of CWP-0403

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical

Criteria

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