A Observational Study to Understand Usage and Effectiveness of Teneligliptin in Indian Patients with Type 2 Diabetes Mellitus

Not Applicable

Conditions: Health Condition 1: null- Type 2 Diabetes Mellitus

Registration Number: CTRI/2018/08/015457

Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patient willing to provide informed consent

2. Female or male patient aged 18 years or above

3. Treatment naÃ¯ve adult patients or adult patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs:

a. HbA1C greater than 6.5%

b. FBG greter than or equal to 140 mg/dL

4. Requirement for teneligliptin as a monotherapy or add-on

5. Patients must provide written consent to use personal and/or health data prior to the entry into the study

Exclusion Criteria

1. Patients with Type 1 diabetes mellitus

2. Patient on DPP 4 inhibitor other than teneligliptin and GLP 1 analogue therapy

3. Any medical condition of the patient which in opinion of Investigator would interfere with safe completion of the study

4. Pregnant and lactating woman

5. Women of child bearing potential not ready to use an effective barrier contraceptive method during the study

6. Patients participating in any other clinical trials

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the change in HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patientsTimepoint: Visit 1 at baseline <br/ ><br>Visit 2 at week 12

Secondary Outcome Measures

Name	Time	Method
1. To assess the change in FBG and PPBG levels from baseline to week 12 <br/ ><br>2. To understand usage pattern of teneligliptin as monotherapy or add-on with other OADs <br/ ><br>3. To assess the effect of teneligliptin treatment on body weight <br/ ><br>4. To assess adverse events during study duration <br/ ><br>5. To assess ECG pattern for QT/QTc prolongation <br/ ><br>Timepoint: Visit 1 at baseline <br/ ><br>Visit 2 at week 12