None listed
Conditions
Interventions
Drug : - Teneligliptine 20mg PO qd for 24weeks
- Teneligliptine 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female aged 19-80 years diagnosed with T2D 2) T2D on stable daily 3 drugs doses for 12 weeks prior to the day of screening of teneliglipite or placebo: metformin (=1000 mg/day), sulfonylureas(=Glimepiride 4 mg/day or =Gliclazide 60 mg/day), SGLT2 inhibitors (availiable drugs in Korea) 3) HbA1c of 8-10.5% at the time of screening 4) T2D who refused insulin therpy suggested by physician 5) T2D who understand the protocol and fully cooperate the clinical trial until the end of the study 6) T2D who are vuluntarily capable of giving signed informed consent
Exclusion criteria
Exclusion criteria: 1) Have type 1 diabetes mellitus, gestational diabetes or other type of diabetes except type 2 diabetes 2) Have a history of insulin injection prior to screening time for more than 1 week consecutively within 1 year 3) Have any other condition (eg, hypersensitivity) that is a contraindication to teneligliptin main incredient 4) Have a history of taking any kind of DPP4 inhibitor prior to screening time within 3 monthos or severe side effects of DPP4 inhibitor 5) Have uncontrolled diabetes requiring immediate therapy (such as coma, acute or chronic diabetic ketoacidosis) at screening or randomization within 12 weeks, in the judgment of the physician 6) Have a history of genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose mal-absorption 7) Those who could not take oral medication (orofacil abnormality or CNS disorders etc.) 8) Have a history of steroid (oral or non-oral route) prior to screening time for more than 14 days consecutively within 8 weeks; except for inhaltor 9) Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years prior to screening time 10) Have chronic New York Heart Association Functional Classification III CHF 11) Have had an MI, surgical or percutaneous coronary revascularization procedure, ischemic stroke, carotid stenting or surgical revascularization, nontraumatic amputation or peripheral vascular procedure (eg, stenting or surgical revascularization) less than 24 weeks prior to screening 12) Those who satarted to take on stain within 4 weeks at the time of screening or are expected to increase the doses of statin during clinical trial 13) Have known chronic renal failure (stage 3,defined as a known CKD-EPI eGFR <30 mL/minute/1.73 m2) or are on chronic dialysis 14) Have acute or chronic hepatitis, signs or symptoms of any other liver disease, or an alanine aminotransferase (ALT), AST, ASL, bilirubin level =2.5X the upper limit of normal (ULN), or Child-Pugh class B or C for the reference range, as determined by the central laboratory 15) Have a history of HIV, HBV, HCV infection within 1 year 16) Women of childbearing or potential or lactation; planning pregnancy 17) Those who are severe infection, traumatized or planning surgery during the clinical trial (who are needed to insulin therapy) 18) Have a history of any other condition (such as known drug or alcohol abuse or psychiatric disorder) 19) Have participated within the last 30 days in a clinical trial involving an investigational product 20) not suitable patients judged by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between baseline and HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between baseline and HbA1c;Percentage of patients who reached target blood glucose (6.5% or 7% as HbA1c);Fasting blood glucose (FPG) | — |
Countries
Korea, Republic of
Contacts
Public ContactByung-Wan Lee
Yonsei University
Outcome results
None listed