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. Metformin does not usually have these unwanted effects, and it is the standard first line therapy in treating type 2 diabetic mellitus in European union. * Nonclinical pharmacodynamic studies revealed that MP-513 effectively improves glucose tolerance in animal models of type 2 diabetes, whilst the compound has very little potential to cause hypoglycaemia, the most commonly reported adverse event with many currently marketed products. * The nonclinical studies also suggested that the inhibitory effect of MP-513 on DPP-Ⅳ is more potent and durable than other DPP-Ⅳ inhibitors in development. The result in safety pharmacology and toxicology also revealed that MP-513 has a relatively wide margin for safety. * Thus, MP-513 is expected to have good efficacy and tolerability in subjects with type 2 diabetes mellitus by once-daily administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
189
Handok Pharmaceuticals CO. LTD
Seoul, Seoul, South Korea
HbA1c
Time frame: Change from Visit 1(Baseline Visit) in HbA1c at Visit 5(week 16)
FPG(Fasting Plasma Glucose)
Time frame: Change from Visit 1(Baseline Visit) in FPG at Visit 5(week 16)
Weight
Time frame: Change from Visit 1(Baseline Visit) in weight at Visit 5(week 16)
BMI
Time frame: Change from Visit 1(Baseline Visit) in BMI at Visit 5(week 16)
HbA1c <7.0%
Time frame: The proportion of patients who achieve an HbA1c<7.0% at Visit 5(week 16)
HbA1c <6.5%
Time frame: The proportion of patients who achieve an HbA1c<6.5% at Visit 5(week 16)
Total Cholesterol
Time frame: Change from Visit 1(Baseline Visit) in Total Cholesterol at Visit 5(week 16)
LDL Cholesterol
Time frame: Change from Visit 1(Baseline Visit) in LDL Cholesterol at Visit 5(week 16)
HDL Cholesterol
Time frame: Change from Visit 1(Baseline Visit) in HDL Cholesterol at Visit 5(week 16)
Triglyceride
Time frame: Change from Visit 1(Baseline Visit) in Triglyceride at Visit 5(week 16)
C-peptide
Time frame: Change from Visit 1(Baseline Visit) in C-peptide at Visit 5(week 16)
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Insulin
Time frame: Change from Visit 1(Baseline Visit) in insulin at Visit 5(week 16)
hsCRP
Time frame: Change from Visit 1(Baseline Visit) in hsCRP at Visit 5(week 16)
HOMA-β
Time frame: Change from Visit 1(Baseline Visit) in HOMA-β at Visit 5(week 16)
HOMA-IR
Time frame: Change from Visit 1(Baseline Visit) in HOMA-IR at Visit 5(week 16)