Study on Effect of Teneligliptin versus Sitagliptin based on ECG changes (Electro Cardiogram for QT interval) in type 2 diabetes mellitus patients.

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/10/016150

Enrollment

150

Registered

2018-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Teneligliptin: Dose: 20 mg Frequency: Once daily (OD) Route of administration : oral Total duration: 7 days Control Intervention1: Sitagliptin: Dose: 100mg Frequncy: Once Daily (OD) Rou

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subjects, aged >= 18 and 2. Uncontrolled Type 2 diabetes after Metformin with a haemoglobin A1c (HbA1c) >=7.0 % - 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 2. Uncontrolled Type 2 diabetes after Metformin with a haemoglobin A1c (HbA1c) >=7.0 % - 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The change in QTc interval from baseline and at Visit 3 in both arms. Timepoint: 7 days treatment	—

Secondary

Measure	Time frame
Evaluation of Adverse events in both arms The incidence of hypoglycemia in both armsTimepoint: 7 days treatment	—

Countries

India

Contacts

Public ContactDr Sujoy Ghosh

Institute of Post Graduate Medical Education and Research

drsujoyghosh2000@gmail.com9674625823

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026