Therapeutic Exploratory Study of CWP-0403
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Drug: CWP-0403 50mgDrug: CWP-0403 100mgDrug: placebo
- Registration Number
- NCT00888719
- Lead Sponsor
- JW Pharmaceutical
- 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 patients who are insufficiently controlled by diet and exercise in comparison to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CWP-0403 50mg CWP-0403 50mg - CWP-0403 100mg CWP-0403 100mg - placebo placebo -
- Primary Outcome Measures
Name Time Method Change in HbA1c before and after treatment 12 weeks
- Secondary Outcome Measures
Name Time Method Triglyceride, LDL-cholesterol and HDL-cholesterol change 12 weeks HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%) 12 weeks Fasting blood glucose level change and rate of change 12 weeks Serum insulin, serum C-peptide level change 12 weeks HOMA-R and HOMA-β change rate 12 weeks
Trial Locations
- Locations (10)
Chonbuk National University Hospital
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷Seoul, Korea, Republic of
Gachon Medical School Gil Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hopital
🇰🇷Seoul, Korea, Republic of
Inha University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Holly Family Hospital
🇰🇷Seoul, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Seoul, Korea, Republic of