A Randomized, Placebo-controlled Clinical Trial of Teneligliptin as Quadruple Oral Combination Therapy for Type 2 DM After Failure of an Oral Triple Anti-diabetic Regimen

Inclusion criteria

• Age over 18 years and less than 81 years
• Patients with type 2 diabetes prescribed with triple combination of oral antidiabetic drugs more than 12 weeks with sufficient doses (metformin >= 1000mg/d, Glimepiride >=4 mg/day, Gliclazide >= 60 mg/day, SGLT-2 inhibitor with approved dose by Korea FDA)
• Uncontrolled hyperglycemia with 7.1% ≤ HbA1c ≤ 9% at randomization period
• Recommended to use insulin by physicians
• Patients able to understand study protocol and cooperative
• Voluntary consent to participation of study after understanding study protocol

Exclusion criteria

• Type 1 diabetes, gestational diabetes, other than type 2 diabetes
• Insulin treatment more than 1 week (not necessarily continuous use) prior to screening visit within 1 year
• Hypersensitivity to TENELIA tablet including main and other component
• Use of DPP4 inhibitor more than 1 week prior to screening visit within 3 months or discontinuation of DPP4 inhibitor due to severe side effects regardless of treatment period
• History of acute or chronic metabolic acidosis and ketosis including diabetic ketoacidosis with/without comma prior to screening visit within 12 weeks
• Genetic trait of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption
• Difficulty in oral ingestion of drug owing to anatomical abnormalities in head and neck area, or owing to abnormalities in central nervous system
• Steroid use including per oral and non-oral more than 14 consecutive days prior to screening visit within 8 weeks (inhaled steroid use is permitted)
• Histories of any malignancy prior to screening visit within 5 years
• History of congestive heart failure (>= 10) NYHA class III)
• Uncontrolled arrhythmia, unstable angina, myocardial infarction, stroke, transient ischemic attack, cerebrovascular disease prior to screening visit within 24 weeks
• Initiation of statin to treat dyslipidemia prior to screening visit within 4 weeks or anticipated increasing dose of statin during study period
• Renal failure, chronic kidney disease stage <=3 (estimated glomerular filtration rate <30 mL/min/1.73 m2, calculated using EKD-EPI) or patients with dialysis
• Abnormalities in liver function test: AST, ALT, or ALP >= 2.5 fold of ULN or patients with liver cirrhosis (Child-Pugh class B or C)
• Infection of HIV, HBV, or HCV and patients subjected to anti-viral therapy within 1 year
• Pregnant or lactating women; or planning to be pregnant
• Patients with other severe infection or with severe injuries, or patients expecting any surgery with transient insulin use for peri-operational glucose control
• Alcohol or any psychotropic substances dependancy , or dependency of any unapproved substances
• Last visit of other clinical trials for treatment purposes prior to screening visit within 30 days
• Other inappropriate properties judged by researchers