Health Condition 1: null- Type 2 Diabetes
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceutical Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in QTc interval in ECG from baseline to week 4 and 12Timepoint: At baseline, week 4 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in HbA1c, FBG and PPBG levels from baseline to week 12 To understand usage pattern of teneligliptin in diabetic patients as a monotherapy or add-on with other OADs To assess adverse events during study duration Timepoint: At baseline, week 4 and Week 12 | — |
Countries
India
Contacts
Public ContactMr Altaf Makwana
Torrent Pharmaceuticals Ltd
Outcome results
None listed