Clinical trial NCT00888719: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 145
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c before and after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: HbA1c target achievement rate(Ratio of the patients with HbA1c lower than 6.5% or 7%)
timeFrame: 12 weeks
measure: Fasting blood glucose level change and rate of change
timeFrame: 12 weeks
measure: Serum insulin, serum C-peptide level change
timeFrame: 12 weeks
measure: HOMA-R and HOMA-β change rate
timeFrame: 12 weeks
measure: Triglyceride, LDL-cholesterol and HDL-cholesterol change
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Gachon Medical School Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hopital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Holly Family Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: KunHo Yoon
role: PRINCIPAL_INVESTIGATOR
References: