Assessing Patient Profiles and Outcomes with Vildagliptin 100 mg Sustained Release (SR) in Individuals Diagnosed with Type 2 Diabetes Mellitus

Abstract

Background: This study centers around Vildagliptin 100 mg Sustained Release (SR) Once Daily (OD), a Dipeptidyl Peptidase IV (DPP-4) inhibitor used to treat Type 2 Diabetes mellitus (T2D). Its once-daily formulation reduces pill burden and improves compliance. With the sustained release formulation, there is an extended release of Vildagliptin in a programmed manner. Since real-world data on patient profile, outcomes, and safety are scarce, this study aims to assess the effectiveness of Vildagliptin 100mg SR OD in individuals with T2D with respect to glycemic parameters.

Methodology: A cohort of 3,316 participants from 146 Indian sites was enrolled based on the criterion of having visited twice within the preceding year, meeting inclusion criteria, and receiving a prescription for Vildagliptin 100mg SR once daily. All participating sites were provided with an electronic Case Report Form (eCRF) for the collection of anonymized data. Ethical approval for this study was obtained from the Institutional Ethics Committee (IEC) Udyaan Healthcare (Registration No. ECR/1300/Inst/UP/2019).

Results: The study involved 3,316 participants, with 65.5% males and 34.5% females. After a 3-month follow-up, HbA1c levels decreased on average by 0.7% (8.0% to 7.3%, p-value <0.001). Those with a baseline HbA1c of >=9% saw a notable drop of 1.1%. The obese group had a weight reduction of 2.7 kgs, surpassing the non-obese group’s drop of 1.5 kgs. The HTN group showed a more considerable reduction in HbA1c levels (0.67% vs. 0.58%) compared to the non-HTN group.

Conclusion: The administration of 100 mg SR Vildagliptin once daily proves to be an effective and well-tolerated strategy for achieving glycemic control. However, it is essential to emphasize the necessity for additional future research to deepen our understanding and optimize the utilization of this treatment approach.