Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGCWP-0403 100mg
100mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
DRUGplacebo
Tablet not containing CWP-0403 and indistinguishable from CWP-0403 50mg, 100mg tablets. Twice a day, 1 tablet at a time for 12 weeks
DRUGCWP-0403 50mg
50mg/tablet, Twice a day, 1 tablet at a time for 12 weeks
Sponsors
JW Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c before and after treatment | 12 weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed