Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Vildagliptin 100 mg SR tablet (Jalra-OD®): One tablet (100 mg) once daily around the same time for 112 days.
Control Intervention1: Sitagliptin 100 mg tablet: One tablet (100 mg) once d
Sponsors
USV Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects of >18 years to 2. subjects who were on metformin at a stable dose for at least one month before enrolment. 3. Subjects with HbA1c value between =8% - <11%.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to any of the components of the formulation. 2. Subjects with a history of Type 1 Diabetes Mellitus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1C from baseline to week 16 (Day 112).Timepoint: Mean change in HbA1C from week 1 to week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in FBG from baseline to week 16 (Day 112). 2. Mean change in PPBG from baseline to week 16 (Day 112).Timepoint: 1. Mean change in FBG from week 1 to week 16. 2. Mean change in PPBG from week 1 to week 16. | — |
Countries
India
Contacts
Public ContactDr Sona Warrier
Mediclin Clinical Research
Outcome results
None listed