Effectiveness and Safety of Vildagliptin Sustained Release in the Management of Type 2 Diabetes Mellitus: Real-World Evidence in Indian Patients [NOVELTY Study]

Rakesh Sahay; Anil Bhansali; Surendra Kumar Sharma; Rahul Iyer; Amarnath Sugumaran; Senthilnathan Mohanasundaram; Jaideep Gogtay

doi:10.1007/s40801-024-00473-8

Effectiveness and Safety of Vildagliptin Sustained Release in the Management of Type 2 Diabetes Mellitus: Real-World Evidence in Indian Patients [NOVELTY Study]

Drugs Real World Outcomes. 2025 Jan 16. doi: 10.1007/s40801-024-00473-8. Online ahead of print.

Authors

Rakesh Sahay¹, Anil Bhansali², Surendra Kumar Sharma³, Rahul Iyer⁴, Amarnath Sugumaran⁵, Senthilnathan Mohanasundaram⁵, Jaideep Gogtay⁵

Affiliations

¹ Department of Endocrinology, Osmania Medical College and Hospital, Hyderabad, India.
² Gini Health, Chandigarh, India.
³ Galaxy Specialty Center, Jaipur, India.
⁴ Department of Medical Affairs, Cipla Ltd., Mumbai Central, Mumbai, Maharashtra, 400008, India. [email protected].
⁵ Department of Medical Affairs, Cipla Ltd., Mumbai Central, Mumbai, Maharashtra, 400008, India.

PMID: 39821190
DOI: 10.1007/s40801-024-00473-8

Abstract

Background and objective: Vildagliptin sustained release (XR), a formulation that provides vildagliptin 100 mg with a once-daily dose administration, is a recent introduction to manage type 2 diabetes mellitus in India. This study aimed to evaluate the effectiveness and tolerability of vildagliptin XR in patients with type 2 diabetes in real-world clinical settings.

Methods: This was an observational, prospective, multicenter, cohort study conducted in India, which included patients with type 2 diabetes uncontrolled on metformin XR monotherapy with glycated hemoglobin (HbA1c) > 7.00%. Vildagliptin XR was added to their ongoing treatment. The primary endpoint was a change in HbA1c from baseline to 3 months. Secondary endpoints were changes in fasting plasma glucose, postprandial plasma glucose, percentage of patients achieving HbA1c < 7.00% at 3 months, and assessment of efficacy, tolerability, and safety.

Results: A total of 1691 patients from 118 centers were enrolled in this study, having a mean (standard deviation) age of 53.10 (11) years and a mean (standard deviation) HbA1c of 8.44 (1.35) %. At the end of the study, vildagliptin XR significantly reduced the mean HbA1c by 1.02% points (95% confidence interval 0.93-1.12; p < 0.001) from baseline. The mean fasting plasma glucose and postprandial plasma glucose levels were significantly reduced by 28.44 mg/dL (95% confidence interval 26.64-30.25; p < 0.001) and 48.45 mg/dL (95% confidence interval 45.91-50.99; p < 0.001), respectively, with vildagliptin XR, at the end of study. During the study duration, 34.7% of patients achieved their glycemic target (HbA1c < 7.0%) and there were three reported adverse events (all mild in severity).

Conclusions: Results demonstrated that vildagliptin XR (100 mg once daily) significantly improved HbA1c and other glycemic parameters in Indian patients with type 2 diabetes and was well tolerated.

Clinical trial registration: The study was registered under the Clinical Trials Registry India (CTRI/2022/01/039112).