Therapeutic Exploratory Study of CWP-0403

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888719
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : November 5, 2010
Information provided by:
JW Pharmaceutical

April 27, 2009
April 28, 2009
November 5, 2010
February 2009
January 2010   (Final data collection date for primary outcome measure)
Change in HbA1c before and after treatment [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00888719 on Archive Site
  • HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%) [ Time Frame: 12 weeks ]
  • Fasting blood glucose level change and rate of change [ Time Frame: 12 weeks ]
  • Serum insulin, serum C-peptide level change [ Time Frame: 12 weeks ]
  • HOMA-R and HOMA-β change rate [ Time Frame: 12 weeks ]
  • Triglyceride, LDL-cholesterol and HDL-cholesterol change [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: CWP-0403 100mg
    100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
  • Drug: placebo

    Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.

    Twice a day, 1 tablet at a time for 12 weeks

  • Drug: CWP-0403 50mg
    50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
  • Experimental: CWP-0403 50mg
    Intervention: Drug: CWP-0403 50mg
  • Experimental: CWP-0403 100mg
    Intervention: Drug: CWP-0403 100mg
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Hyung kyu, Park, ChoongWae Pharma Corporation
JW Pharmaceutical
Not Provided
Principal Investigator: KunHo Yoon The Catholic University of Korea
JW Pharmaceutical
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP