An observational study to understand usage, safety and effect of Teneligliptin in diabetic patients with chronic kidney disorder

Not Applicable

Conditions: Health Condition 1: null- Diabetes Mellitus Type II with Chronic Kidney Disease

Registration Number: CTRI/2017/08/009269

Lead Sponsor: Torrent Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

HbA1C >6.5%

FBG >=140 mg/dL

eGFR <90 ml/min/1.73 m2

2.Physician prescribes teneligliptin as a monotherapy or add-on

3.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.Contraindications for teneliglitpin as per approved local prescribing information

4.Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participation of subject in the study

5.Pregnant and lactating woman and women of child bearing potential not ready to use an effective barrier contraceptive method during the study

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess the change in HbA1c levels from baseline to week 12 and 24 <br/ ><br>2.To assess the change in Estimated Glomerular Filtration Rate (eGFR) level from baseline to week 24 <br/ ><br>Timepoint: At baseline <br/ ><br>Week 12 <br/ ><br>Week 24

Secondary Outcome Measures

Name	Time	Method
1.To assess the change in FBG and PPBG levels from baseline to week 12 and 24 <br/ ><br>2.To assess the change in albumin-creatinine ratio (ACR) from baseline to week 24 <br/ ><br>3.To understand usage pattern of teneligliptin in CKD patients as a monotherapy or add-on with other OADs <br/ ><br>4.To assess adverse events during study duration <br/ ><br>Timepoint: At baseline to week 12 and 24