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.
1 other identifier
interventional
145
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Feb 2009
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedNovember 5, 2010
November 1, 2010
11 months
April 27, 2009
November 3, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1c before and after treatment
12 weeks
Secondary Outcomes (5)
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
Study Arms (3)
CWP-0403 50mg
EXPERIMENTALCWP-0403 100mg
EXPERIMENTALplacebo
PLACEBO COMPARATORInterventions
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Chonbuk National University Hospital
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Gachon Medical School Gil Medical Center
Seoul, South Korea
Inha University Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyungpook National University Hospital
Seoul, South Korea
Seoul National University Bundang Hopital
Seoul, South Korea
The Catholic University of Korea, Holly Family Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KunHo Yoon
The Catholic University of Korea
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 28, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
April 1, 2010
Last Updated
November 5, 2010
Record last verified: 2010-11