Treatment of Type 2 Diabetes with Vildagliptin 100 mg SR tablet (Jalra-OD).
Not Applicable
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/08/056116
- Lead Sponsor
- SV Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Male or Female subjects of >18 years to <65 years of age diagnosed with type 2 diabetes mellitus.
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
1. Subjects with known hypersensitivity to any of the components of the formulation.
2. Subjects with a history of Type 1 Diabetes Mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1C from baseline to week 16 (Day 112).Timepoint: Mean change in HbA1C from week 1 to week 16.
- Secondary Outcome Measures
Name Time Method 1. Mean change in FBG from baseline to week 16 (Day 112). <br/ ><br>2. Mean change in PPBG from baseline to week 16 (Day 112).Timepoint: 1. Mean change in FBG from week 1 to week 16. <br/ ><br>2. Mean change in PPBG from week 1 to week 16.