Status:
COMPLETED
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
Lead Sponsor:
Yonsei University
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04446026
Start Date
July 8 2020
End Date
May 17 2021
Last Update
June 9 2021
Active Locations (1)
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1
Yonsei Severance Hospital
Seoul, South Korea