The study design of this trial is double blind, parallel-group, randomized, placebo controlled study
* Although many different oral antidiabetic agents are currently available, approximately 50% of treated Type 2 diabetic subjects do not reach currently accepted goals for HbA1c(Oral communication, American Diabetic Association, 2008)Subjects are frequently prescribed agents which can cause hypoglycemia, and/or weight gain. * In many countries, the most commonly prescribed primary oral diabetes drug that does not cause hypoglycemia or weight gain, is metformin, but metformin can cause gastrointestinal adverse drug reactions, nausea, vomiting, diarrhea, abdominal pain and loss of appetite and other symptoms, and rare but life-threatening lactic acidosis. * This decrease in the Power of Hydrogen Ions of the blood (\<7.25) and the increase in blood lactate (\> 5 mmol / L) is associated with a reduced kidney failure and if there is kidney impairment, decreased metformin clearance and thus accumulated metformin may occur lactic acidosis more frequently. Also there is inconvenience, such as adjusting metformin dose depending on patient's condition. * MP-513 is expected to be safely used as a treatment for type 2 diabetes because it has no risk of hypoglycemia and/or weight gain which are reported in pre-existing diabetes therapies and no inconvenience related to dose adjustment depending on patient's condition, and no cases of fatal side effects. * Furthermore the inhibitory effect on Dipeptidyl peptidase-IV was stronger and half-life was longer compared with other dipeptidyl peptidase-IV inhibitors in non-clinical trial, and blood glucose moderating effects are proven to be clinically significant in clinical trials conducted in Europe and Japan in that its development as a therapeutic agent for patients with type 2 diabetes is considered to be promising. * Based on these previous studies, the objective of this study is to investigate the efficacy and safety in subjects with type 2 diabetes mellitus that is not adequately controlled with exercise and diet.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
142
Handok INC
Seoul, Gangnam-Gu, South Korea
Handok Pharmaceuticals CO. LTD
Seoul, South Korea
Glycosylated hemoglobin
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Mean fasting plasma glucose
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Weight
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Glycosylated hemoglobin <7.0% subject percent
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Triglycerides
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Homeostatic model assessment of insulin Resistance
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Body mass index
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Low Density Lipoprotein
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
High Density Lipoprotein
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Cholesterol
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Connecting peptide
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Insulin
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Homeostatic model assessment of beta-cell function
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)
Glycosylated hemoglobin <6.5% subject percent
Time frame: Visit 1(Baseline Visit) vs Visit 7(week 24)