QT/QTc safety and efficacy evaluation of Teneligliptin in Indian type 2 diabetes mellitus patients: the “thorough QT/QTc” study (Q-SET study)
3rd International Conference on Diabetes and Metabolism
November 29-30, 2019 | Frankfurt, Germany
Suhas Gopal Erande
Diabetic Speciality Centre & Insulin Pump Centre Akshay Hospital, India
Keynote : J Diabetol
Therapeutic armamentarium of T2DM has been rapidly
expanding over last decade & dipeptidyl peptidase
IV inhibitors (gliptins) have emerged as safe, efficacious,
durable class. In this same timeframe, ADA-EASD guidelines
have become more patient centric & the USFDA has given a
mandate to prove cardiovascular safety before marketing any
Teneligliptin is a very widely used drug for T2DM in India since 2015. Therapeutic doses of teneligliptin(20 or 40 mg/ day) have not been known to alter the QT interval in ECG, but, supratherapeutic doses(160mg/day) may prolong the same. Similar observations are made with sitagliptin (50 or 100 mg/d safe-but-400mg/d may prolong QT interval). Since prolongation of QT interval can increase risk of polymorphic ventricular tachyarrythmia Torsade de Pointes, this scrutiny is essential.
Since there is no devoted study to assess if routine doses of teneligliptin(20 or 40mg/day) are safe with respect to effect on QT interval, we undertook this exercise.
We selected 66 adult nonpregnant T2DM patients (age >18 yrs <65 yrs) who were gliptin naïve & on standard antidiabetic treatment, but, uncontrolled(HbA1c>7%). Teneligliptin 20mg/day was added to therapy & if needed, doubled to 40mg/day. Other drugs were unchanged through the study duration (unless compelling clinically). Baseline 12 lead ECG was recorded & also within 120 minutes of the 1st, 15th & 90th day of teneligliptin. Glycemic parameters were recorded alongwith other laboratory tests. QT interval was measured for each of these 4 ECGs (baseline, day 1, day 15 & 90) & QTc was calculated as per Bazett’s formula(QTc=QT/ sq root RR interval).
It was observed that there was no increase in QT/QTc interval after 3 months of teneligliptin treatment(along with other antidiabetic drugs like glimepiride, pioglitazone, metformin). The drug improved glycemic parameters & without noteworthy adverse events. Larger studies & longer observation periods may help in future.
Suhas Gopal Erande is a practicing consultant who is having own Diabetes centre & Insulin Pump Clinic at Akshaya Hospital, India. He has been writing Diabetes Patient Education books over 2 decades. Felicitated for social services for diabetes by ‘Diabetes Mitra’ award. He has written academic articles for physicians at National & International levels. Publications in National & International journals. He has been writing chapters in textbooks over years. Invited for poster presentation on Intensive Glucose Monitoring in Bethesda Baltimore 2016 Diabetes Technology Society Meet Invited for Global Diabetes Conference. For Diabetes in Women lecture in Prague August 2017. His recently published studies Prevalence of depression in T2DM in India(DEPTH study) & effect of teneligliptin on QT-QTc interval(Q SET study) have got International acclaim.