Therapeutic Exploratory Study of CWP-0403

JW Pharmaceutical

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: CWP-0403 50mg

Drug: CWP-0403 100mg

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00888719

CWP-SKD-201

Details and patient eligibility

About

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.

Enrollment

145 patients

Sex

All

Ages

25 to 75 years old

Volunteers

No Healthy Volunteers

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