A Double Blind Comparative Prospective Study of the Safety of Teneligliptin and Sitagliptin to Evaluate QTc Prolongation in Indian Type 2 Diabetes Patients

Dr Sujoy Ghosh0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male or female subjects, aged >= 18 and <= 65 years at the time of informed consent
•2. Uncontrolled Type 2 diabetes after Metformin with a haemoglobin A1c
•(HbA1c) >=7.0 % - <= 10%
•3. Type 2 Diabetic patients who are gliptins naÃ¯ve
•4. Provide written informed consent
•5. Willing and able to comply with all aspects of the protocol.Male or female subjects, aged >= 18 and <= 65 years at the time of informed consent
•2. Uncontrolled Type 2 diabetes after Metformin with a haemoglobin A1c
•(HbA1c) >=7.0 % - <= 10%
•3. Type 2 Diabetic patients who are gliptins naÃ¯ve
•4. Provide written informed consent
•5. Willing and able to comply with all aspects of the protocol

•1. Type 1 diabetes
•2. Patients on Insulin therapy
•3. Severe diabetic complications such as ketoacidosis
•4. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
•QTc interval >450 milliseconds (ms))
•5. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family
•history of Long QT Syndrome)
•6. The use of concomitant medications that prolong the QT/QTc interval
•7. Liver dysfunction
•8. Pregnant or nursing women and those who might be pregnant
•9. Patients with a history of seizures
•10. A history of stroke and cardiovascular events
•11. Any patient whom the investigator judged to be inappropriate for this study
•12. Patients with a history of alcohol or drug abuse
•13. Any patients with H/o cardiovascular diseases.
•14. Thyroid Dysfunction
•15. Calcium dysfunction

发起方

Dr Sujoy Ghosh