Clinical Efficacy and Safety Evaluation of Teneligliptin in Type 2 Diabetes Who Have Inadequate GlycemIc Control With Empaglyflozin and Metformin

A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin

The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and metformin

Inclusion Criteria:

• Patients with Type II diabetes mellitus aged 19 years or older
• Subjects with 7.0%≤HbA1c≤10.5% at screening visit
• Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit

Exclusion Criteria:

• Subjects with type 1 diabetes mellitus or secondary diabetes
• Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
• Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
• Body mass index greater than 40 kg/m2 at the screening visit
• Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment