Therapeutic Exploratory Study of CWP-0403

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888719
• Other study ID #: CWP-SKD-201
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2009
• Last updated: November 3, 2010
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: November 2010
• Source: JW Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age of=25 and <75 with type? 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:

• Type?DM, 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• CWP-0403 100mg
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
• 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
• CWP-0403 50mg
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Gachon Medical School Gil Medical Center	Seoul
Korea, Republic of	Inha University Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyungpook National 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, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Vincent's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c before and after treatment		12 weeks	No
Secondary	HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)		12 weeks	No
Secondary	Fasting blood glucose level change and rate of change		12 weeks	No
Secondary	Serum insulin, serum C-peptide level change		12 weeks	No
Secondary	HOMA-R and HOMA-ß change rate		12 weeks	No
Secondary	Triglyceride, LDL-cholesterol and HDL-cholesterol change		12 weeks	No