Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing to provide informed consent 2. Female or male patient aged 18 years or above 3. Treatment naïve 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in HbA1c levels from baseline to week 12 in Indian Type 2 diabetes mellitus patientsTimepoint: Visit 1 at baseline Visit 2 at week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the change in FBG and PPBG levels from baseline to week 12 2. To understand usage pattern of teneligliptin as monotherapy or add-on with other OADs 3. To assess the effect of teneligliptin treatment on body weight 4. To assess adverse events during study duration 5. To assess ECG pattern for QT/QTc prolongation Timepoint: Visit 1 at baseline Visit 2 at week 12 | — |
Countries
India
Contacts
Public ContactDr Amit Gajjar
Torrent Pharmaceuticals Ltd
Outcome results
None listed