A study to assess effect of teneligliptin on heart rhythm in patients with diabetes
- Conditions
- Health Condition 1: null- Type 2 Diabetes
- Registration Number
- CTRI/2018/02/012072
- Lead Sponsor
- Torrent Pharmaceutical Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patient willing to provide informed consent
Female or male patient aged 60 years or above
Treatment naïve patients or patients who had inadequately controlled type 2 diabetes mellitus despite using diet plus exercise and/or OADs: a. HbA1C greater than 6.5% b. FBS more than or equal to 140 mg per dL
Patient is prescribed teneligliptin 40mg as a monotherapy or add on therapy
Patients must provide written consent to use personal and/or health data prior to the entry into the study
Patients with Type 1 diabetes mellitus
Patient on DPP-4 inhibitor other than teneligliptin and GLP-1 analogue therapy
Contraindications for teneliglitpin as per approved prescribing information
Patients taking any other drug prolonging QT interval.
Any reasons of medical and non-medical character, which in the opinion of the physician can prevent participation of subject in the study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the change in QTc interval in ECG from baseline to week 4 and 12Timepoint: At baseline, week 4 and week 12
- Secondary Outcome Measures
Name Time Method To assess the change in HbA1c, FBG and PPBG levels from baseline to week 12 <br/ ><br> <br/ ><br>To understand usage pattern of teneligliptin in diabetic patients as a monotherapy or add-on with other OADs <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>To assess adverse events during study duration <br/ ><br>Timepoint: At baseline, week 4 and Week 12