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. 2025 Apr 18;17(4):e82549.
doi: 10.7759/cureus.82549. eCollection 2025 Apr.

Efficacy and Safety of Vildagliptin Sustained-Release and Metformin Sustained-Release Fixed-Dose Combination in Indian Patients With Type 2 Diabetes Mellitus: A Real-World Perspective

Archana Sarda  1 , Bhavana Sosale  2 , Balaji Jagan Mohan  3 , Snehal Tanna  4 , Vipul Gupta  5 , Sanjay Gupta  6 , Deepak Langade  7 , Rahul Kotwal  8 , Vivek Kolapkar  8 , Kamlesh Patel  8
Affiliations

Efficacy and Safety of Vildagliptin Sustained-Release and Metformin Sustained-Release Fixed-Dose Combination in Indian Patients With Type 2 Diabetes Mellitus: A Real-World Perspective

Archana Sarda et al. Cureus. .

Abstract

Introduction The efficacy of vildagliptin as an add-on to metformin has been demonstrated in type 2 diabetes mellitus (T2DM) patients inadequately controlled on metformin monotherapy, as well as in early combination therapy for newly diagnosed T2DM patients. However, there is limited evidence on the efficacy and safety of a fixed-dose combination (FDC) of vildagliptin sustained-release (SR) and metformin SR in these patient groups. This study evaluated the efficacy and safety of an FDC of vildagliptin SR and metformin SR in patients with T2DM in real-world clinical settings across India. Methods A retrospective, multicenter, post-marketing study was conducted. Data from T2DM patients across 95 centers in India were collected and analyzed retrospectively. The study included adults (18-65 years) diagnosed with T2DM who were either newly diagnosed or inadequately controlled on existing therapy and were prescribed vildagliptin SR 100 mg and metformin SR 500/1000 mg FDC at the discretion of their treating physician. Primary outcomes assessed were reductions in HbA1c (%), fasting plasma glucose (FPG), and postprandial plasma glucose (PPG) from baseline to day 90. Results Data from 1,090 patients were included for analysis. The mean age of the patients was 54.46 years, and the mean baseline HbA1c was 8.19 ± 1.22%. The FDC of vildagliptin 100 mg SR and metformin 500 mg SR was prescribed to 89.26% of patients, while the FDC of vildagliptin 100 mg SR and metformin 1000 mg SR was prescribed to 10.73%. The overall study population showed a reduction of -0.81 ± 1.00% in HbA1c (p < 0.0001). Significant reductions in FPG of -28.61 ± 35.15 mg/dL (p < 0.0001) and in PPG of -42.32 ± 52.19 mg/dL (p < 0.0001) were observed. No serious adverse events were reported during the study. Conclusion The FDC of vildagliptin SR and metformin SR was effective, safe, and well-tolerated for managing T2DM in patients who were either newly diagnosed or inadequately controlled on other antidiabetic agents in Indian real-world settings.

Keywords: early combination; fixed-dose combination; glycemic control; treatment-naïve; vildagliptin sr.

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Conflict of interest statement

Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Institutional Ethics Committee of D. Y. Patil University School of Medicine, Navi Mumbai issued approval DYP/IECBH/2023/123. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: Rahul Kotwal, Vivek Kolapkar, Kamlesh D Patel declare(s) employment from Lupin Limited, Mumbai. All other authors declairs no conflict of interest. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.

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