Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes

• Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The change from Baseline in Fasting Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline Fasting Plasma Glucose as a covariate.
• Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.
• Change From Baseline in the Areas Under the Curve From 0 to 2 h (AUC0-2h) for Postprandial Plasma Glucose at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  The change from Baseline in AUC0-2h for Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.

• Blood glucose, Immuno Reactive Insulin (IRI), Glucagon, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
• Adverse events, laboratory tests, vital signs, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the efficacy and safety and to determine the appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment manner.

• Drug: Teneligliptin 10mg
  Other Name: MP-513
• Drug: Teneligliptin 20 mg
  Other Name: MP-513
• Drug: Teneligliptin 40 mg
  Other Name: MP-513
• Drug: Placebo

• Experimental: Teneligliptin 10 mg
  Teneligliptin 10 mg, orally, once daily
  Intervention: Drug: Teneligliptin 10mg
• Experimental: Teneligliptin 20 mg
  Teneligliptin 20 mg, orally, once daily
  Intervention: Drug: Teneligliptin 20 mg
• Experimental: Teneligliptin 40 mg
  Teneligliptin 40 mg, orally, once daily
  Intervention: Drug: Teneligliptin 40 mg
• Placebo Comparator: Placebo
  Teneligliptin placebo-matching tablets, orally, once daily
  Intervention: Drug: Placebo

Inclusion Criteria:

• Patients who are 20 - 75 years old
• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
• Patients whose HbA1c is 6.5 - 9.5%
• Patients who were not administered drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.

Exclusion Criteria:

• Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or secondary diabetes (Cushing disease, acromegaly, etc)
• Patients with Class III/IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
• Patients with serious diabetic complications
• Patients who are habitual excessive alcohol consumption.
• Patients with severe hepatic disorder or severe renal disorder.
• Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception