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

Phase 4

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

• Registration Number: CTRI/2018/10/016150
• Lead Sponsor: Dr Sujoy Ghosh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in QTc interval from baseline and at Visit 3 in both arms. <br/ ><br>Timepoint: 7 days treatment

Secondary Outcome Measures

Name	Time	Method
Evaluation of Adverse events in both arms <br/ ><br>The incidence of hypoglycemia in both armsTimepoint: 7 days treatment