CTRI/2021/10/037574CompletedPhase 4
Comparison of efficacy and safety of Viladagliptin 50 mg tablet twice daily and metformin combination therapy with Vildagliptin 100 mg sustained release tablet once daily and metformin combination therapy in Indian patients with type 2 diabetes mellitus: A randomized open label phase IV clinical trial
Dr Rudra Paul1 site in 1 country34 target enrollmentStarted: January 11, 2021Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in HbA1C At week 12 visit
Study Overview
Brief Summary
Present study is aimed to compare efficacy and safety of Metformin and Vildagliptin 100 mg SR combination therapy with Metformin and Vildagliptin 50 mg twice daily combination therapy
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 Age > 18 yrs 2 Newly Diagnosed cases with type 2 diabetes mellitus 3 HbA1C ≥ 6.5 & ≤ 8.
Exclusion Criteria
- •ï¶Female patients who are pregnant or lactating 1 FPG > 250mg/dl, PPPG > 350mg/dl 2 Co-morbid cardiovascular, hepatic renal and psychatric complications 3 Co-administration of drugs that are likely to interact with vildagliptin or metformin.
Outcomes
Primary Outcomes
Change in HbA1C At week 12 visit
Time Frame: Change in HbA1C At week 12 visit
Secondary Outcomes
- Change in FPG, PPPG at week 4, 8 and 12 visits(At the intervals of weeks 4, 8 and 12)
Investigators
Study Sites (1)
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