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Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 05:44:15 GMT)

CTRI Number CTRI/2018/10/016150 [Registered on: 25/10/2018] - Trial Registered Prospectively Last Modified On 22/10/2018 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study Study on Effect of Teneligliptin versus Sitagliptin based on ECG changes (Electro Cardiogram for QT interval) in type 2 diabetes mellitus patients. Scientific Title of A Double Blind Comparative Prospective Study of the Safety of Teneligliptin and Sitagliptin to Study Evaluate QTc Prolongation in Indian Type 2 Diabetes Patients Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sujoy Ghosh Trial Coordinator (multi-center study) Designation Consultant Diabetology and Endocrinologist Affiliation Institute of Post Graduate Medical Education and Research Address 244, AJC Bose Road, Room Number 8, 4th Floor Ronald Ross Building, Department of Diabetology and Kolkata 700020 Phone 9674625823 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sujoy Ghosh Query) Designation Consultant Diabetology and Endocrinologist Affiliation Institute of Post Graduate Medical Education and Research Address 244, AJC Bose Road, Room Number 8, 4th Floor Ronald Ross Building, Department of Diabetology and Endocrinology Kolkata Kolkata WEST BENGAL 700020 India Phone 9674625823 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Sujoy Ghosh Designation Consultant Diabetology and Endocrinologist Affiliation Institute of Post Graduate Medical Education and Research Address 244, AJC Bose Road, Room Number 8, 4th Floor Ronald Ross Building, Department of Diabetology and Endocrinology Kolkata Kolkata WEST BENGAL 700020 India

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Phone 9674625823 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Glenmark Pharmaceuticals Limited, Glenmark House, BD Sawant Marg, Andheri East, Mumbai 400099 Primary Sponsor Primary Sponsor Details Name Dr Sujoy Ghosh Address 244, AJC Bose Road, Ronald Ross Building, 4th Floor, Room Number 8, Kolkata 700020 Type of Sponsor Other [Investigator] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Monojit Ketan AMRI Hospitals Scheme-L11, P-4&5 d, 9830203242 Mukhopadhyay Block-A, Department of Endocrinology, Room mkmukhopadhyay@ya Number 4, Ground hoo.co.in Floor Gariahat Roa, , Kolkata, West Bengal 700029 Kolkata WEST BENGAL DrKaushik Pandit AMRI Hospitals Scheme-L11, P-4&5 d, 9433041698 Block-A, Department of Endocrinology, Room [email protected] Number 7, Ground Floor Gariahat Road, Dhakuria, Kolkata, West Bengal 700029 Kolkata WEST BENGAL Dr Sujoy Ghosh Institute of Post 244, AJC Bose Road, 9674625823 Graduate Medical Room Number 8, 4th Education and Floor Ronald Ross drsujoyghosh2000@gm Research Building, Department of ail.com Diabetology and Endocrinology Kolkata Kolkata WEST BENGAL Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? AMRI Hospital Dhakuria Approved 12/06/2018 No AMRI Hospital Dhakuria Approved 12/06/2018 No IPGME&R Research Approved 09/08/2018 No Oversight Committee,Institute of Post Graduate Medical Education & Research Regulatory Clearance Status Date

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Status from DCGI Notified 09/08/2018 Health Condition / Health Type Condition Problems Studied Patients Type 2 diabetes mellitus without complications Intervention / Type Name Details Comparator Agent Intervention Teneligliptin Dose: 20 mg Frequency: Once daily (OD) Route of administration : oral Total duration: 7 days Comparator Agent Sitagliptin Dose: 100mg Frequncy: Once Daily (OD) Route of Administration: Oral Total Treatment duration : 7 days Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 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 naïve
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 naïve
4. Provide written informed consent
5. Willing and able to comply with all aspects of the protocol Exclusion Criteria Exclusion Criteria Details 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 Method of Generating Stratified block randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints

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The change in QTc interval from baseline and at 7 days treatment Visit 3 in both arms.

Secondary Outcome Outcome Timepoints Evaluation of Adverse events in both arms 7 days treatment The incidence of hypoglycemia in both arms Target Sample Size Total Sample Size=150 Sample Size from India=150 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Post Marketing Surveillance Date of First 27/10/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details None Yet

Brief Summary Primary Objective:The primary study objective is to evaluate the percent of patients with ECG changes of QT prolongation in the teneligliptin group versus the sitagliptin group.

Secondary Objective:The primary study objective is to evaluate the percent of patients with ECG changes of QT prolongation in the teneligliptin group versus the sitagliptin group.

Study Rationale

Teneligliptin is orally administered at a dosage of 20 mg once daily, which can be increased up to 40 mg per day. Because the metabolites of this drug are eliminated via renal and hepatic excretion, no dose adjustment is necessary in patients with renal impairment. The safety profile of teneligliptin is similar to those of other available DPP-4 inhibitors

The most important drug-induced form of proarrhythmia is acquired long QT syndrome (LQTS) and resulting potentially fatal polymorphic ventricular tachycardia termed torsades de pointes (TdP).

According to a strict QT/QTc evaluation study and clinical studies for type 2 diabetes conducted in Japan and other countries, NO AEs related to QT prolongation were detected with 40 mg/day of teneligliptin, which is the maximal dosage used in clinical practice.

There is no data regarding the safety of Teneligliptin in Indian type 2 diabetic patients with respect to QTc prolongation. Hence the current study is intended to evaluate the safety of Teneligliptin in type 2 diabetes patients with respect to QTc prolongation.

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