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.

JW Pharmaceutical10 sites in 1 country145 target enrollmentFebruary 2009

ConditionsType 2 Diabetes Mellitus

InterventionsCWP-0403 50mg CWP-0403 100mg placebo

DrugsCWP-0403 50mg CWP-0403 100mg placebo

Overview

Phase: Phase 2
Intervention: CWP-0403 50mg
Conditions: Type 2 Diabetes Mellitus
Sponsor: JW Pharmaceutical
Enrollment: 145
Locations: 10
Primary Endpoint: Change in HbA1c before and after treatment
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

April 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

JW Pharmaceutical

Eligibility Criteria

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.

Arms & Interventions

CWP-0403 50mg

Intervention: CWP-0403 50mg

CWP-0403 100mg

Intervention: CWP-0403 100mg

placebo

Intervention: placebo

Outcomes

Primary Outcomes

Change in HbA1c before and after treatment

Time Frame: 12 weeks

Secondary Outcomes

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)