This is a randomized, placebo-controlled clinical trial of Teneligliptin as quadruple oral combination therapy for type 2 diabetes after failure of an oral triple anti-diabetic regimen. Patients with uncontrolled type 2 diabetes (7.1% ≤ HbA1c ≤ 9%) 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) will be included. Using randomization, patients would take either teneligliptin (20mg) or placebo for 12 weeks. After 12 weeks of trial, all patients would receive teneligliptin for another 12 weeks. As outcomes, changes in HbA1c and fasting plasma glucose at 12th and 24th weeks compared with at baseline, and proportions of patients who achieved a glycemic goal (HbA1c \<=7%) at 12th and 24th weeks will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
teneligliptin 20mg PO qd for 24weeks
teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks
Yonsei Severance Hospital
Seoul, South Korea
Hb1Ac
Difference between baseline and HbA1c at 12 weeks after treatment with test drug
Time frame: 12 weeks
HbA1c
Difference between baseline and HbA1c at 24 weeks after treatment with test drug
Time frame: 24 weeks
Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)
Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug
Time frame: 12 weeks
Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c)
Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c) at 12 and 24 weeks after treatment with the test drug
Time frame: 24 weeks
Fasting glucose
Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug
Time frame: 12 weeks
Fasting glucose
Fasting blood glucose (FPG) at 12 and 24 weeks after treatment with test drug
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.