Therapeutic Exploratory Study of CWP-0403

This study has been completed.
Sponsor:
Information provided by:
JW Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00888719
First received: April 27, 2009
Last updated: November 3, 2010
Last verified: November 2010

April 27, 2009
November 3, 2010
February 2009
January 2010   (final data collection date for primary outcome measure)
Change in HbA1c before and after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00888719 on ClinicalTrials.gov Archive Site
  • HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Fasting blood glucose level change and rate of change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum insulin, serum C-peptide level change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HOMA-R and HOMA-β change rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Triglyceride, LDL-cholesterol and HDL-cholesterol change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
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
Both
25 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00888719
CWP-SKD-201
No
Hyung kyu, Park, ChoongWae Pharma Corporation
JW Pharmaceutical
Not Provided
Principal Investigator: KunHo Yoon The Catholic University of Korea Seoul St.Mary's Hospital
JW Pharmaceutical
November 2010

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