Comparison of utility 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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037574

Enrollment

Registered

2021-10-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Metformin 1000 mg per day and Vildagliptin 100 mg SR: Metformin 1000 mg per day and Vildagliptin 100 mg SR once daily for 12 weeks Control Intervention1: Metformin 1000 mg per day and V

Eligibility

Inclusion criteria

Inclusion criteria: 1 Age > 18 yrs 2 Newly Diagnosed cases with type 2 diabetes mellitus 3 HbA1C >= 6.5 &

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1C At week 12 visitTimepoint: Change in HbA1C At week 12 visit	—

Secondary

Measure	Time frame
Change in FPG, PPPG at week 4, 8 and 12 visitsTimepoint: At the intervals of weeks 4, 8 and 12	—

Countries

India

Contacts

Public ContactDr Arijit Ghosh

NRS Medical College

drarijitghosh@gmail.com9874727137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026