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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CWP-0403 50mg; Drug: CWP-0403 100mg; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Kyungpook National University Hospital
  • Seoul, Korea, Republic of
    • Chonbuk National University Hospital
  • Seoul, Korea, Republic of
    • Gachon Medical School Gil Medical Center
  • Seoul, Korea, Republic of
    • Inha University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hopital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Holly Family Hospital
  • Seoul, Korea, Republic of
    • The Catholic university of Korea, St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	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
Experimental: CWP-0403 50mg	Drug: CWP-0403 50mg; 50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Experimental: CWP-0403 100mg	Drug: CWP-0403 100mg; 100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c before and after treatment	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Triglyceride, LDL-cholesterol and HDL-cholesterol change	12 weeks

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Investigators: Principal Investigator: KunHo Yoon, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): November 5, 2010
• Last Update Submitted That Met QC Criteria: November 3, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CWP-SKD-201