Therapeutic Exploratory Study of CWP-0403 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: CWP-0403 100mg Drug: placebo Drug: CWP-0403 50mg	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by JW Pharmaceutical:

Primary Outcome Measures:

Change in HbA1c before and after treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Fasting blood glucose level change and rate of change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Serum insulin, serum C-peptide level change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
HOMA-R and HOMA-β change rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Triglyceride, LDL-cholesterol and HDL-cholesterol change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	145
Study Start Date:	February 2009
Study Completion Date:	April 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
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

Eligibility

Ages Eligible for Study:	25 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888719

Locations

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

Sponsors and Collaborators

JW Pharmaceutical

Investigators

Principal Investigator:

KunHo Yoon

The Catholic University of Korea Seoul St.Mary's Hospital

More Information

No publications provided

Responsible Party:	Hyung kyu, Park, ChoongWae Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00888719 History of Changes
Other Study ID Numbers:	CWP-SKD-201
Study First Received:	April 27, 2009
Last Updated:	November 3, 2010
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013