Therapeutic Exploratory Study of CWP-0403

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CWP-0403 100mg
* Drug: placebo
* Drug: CWP-0403 50mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CWP-0403 50mg<br> | Drug: CWP-0403 50mg<br>* 50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks<br>|
| Experimental: CWP-0403 100mg<br> | Drug: CWP-0403 100mg<br>* 100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c before and after treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |