Therapeutic Exploratory Study of CWP-0403
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CWP-0403 100mg
placebo
CWP-0403 50mg
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
- 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
Sites / Locations
- Chonbuk National University Hospital
- Ewha Womans University Mokdong Hospital
- Gachon Medical School Gil Medical Center
- Inha University Hospital
- Korea University Guro Hospital
- Kyungpook National University Hospital
- Seoul National University Bundang Hopital
- The Catholic University of Korea, Holly Family Hospital
- The Catholic University of Korea, Seoul St. Mary's Hospital
- The Catholic University of Korea, St. Vincent's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CWP-0403 50mg
CWP-0403 100mg
placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c before and after treatment
Secondary Outcome Measures
HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
Fasting blood glucose level change and rate of change
Serum insulin, serum C-peptide level change
HOMA-R and HOMA-β change rate
Triglyceride, LDL-cholesterol and HDL-cholesterol change
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00888719
Brief Title
Therapeutic Exploratory Study of CWP-0403
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CWP-0403 50mg
Arm Type
Experimental
Arm Title
CWP-0403 100mg
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CWP-0403 100mg
Intervention Description
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets.
Twice a day, 1 tablet at a time for 12 weeks
Intervention Type
Drug
Intervention Name(s)
CWP-0403 50mg
Intervention Description
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Primary Outcome Measure Information:
Title
Change in HbA1c before and after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
Time Frame
12 weeks
Title
Fasting blood glucose level change and rate of change
Time Frame
12 weeks
Title
Serum insulin, serum C-peptide level change
Time Frame
12 weeks
Title
HOMA-R and HOMA-β change rate
Time Frame
12 weeks
Title
Triglyceride, LDL-cholesterol and HDL-cholesterol change
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KunHo Yoon
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gachon Medical School Gil Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hopital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Holly Family Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Therapeutic Exploratory Study of CWP-0403
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