Patient-centered Assessment of the Efficacy and Safety of Vildagliptin Sustained-release Tablet (100 mg) Relative to Sitagliptin (100 mg) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on MEtformin (PRIME-Vilda Trial)
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Abstract
Dipeptidyl peptidase-4 inhibitors (DPP4Is) were introduced for the management of type 2 diabetes mellitus (T2DM) due to their insulinotropic effects, lack of inherent hypoglycemia risk, and neutral impact on body weight. Vildagliptin is a dipeptidyl peptidase-4 inhibitor that improves glycemic control by increasing the incretin levels and prolonging the effect of glucagon-like peptide 1 (GLP- 1). Due to its unique mechanism of action for glycemic control and its advantages, DPP-4 inhibitors have been widely used alone in monotherapy or combined with metformin. The present study aimed to evaluate the efficacy and safety of Vildagliptin 100 mg sustained release tablet once daily (SR tablet OD) compared to Sitagliptin 100 mg tablet in patients with Type 2 diabetes mellitus not optimally controlled on Metformin alone. A total of three sites were involved in the enrollment of 128 Type 2 diabetes mellitus patients, with 64 patients in each treatment arm. 50 patients were selected to monitor the average blood glucose levels by continuous glucose monitoring system (CGMS) measurements in a subset of population with 25 patients in each treatment arm. Eligible patients were randomly assigned to receive (orally) Vildagliptin sustained release tablets 100 mg or Sitagliptin tablets IP 100 mg with metformin once daily for 84 days. The reduction in HbA1c, fasting blood glucose (FBG) levels, postprandial blood glucose (PPBG) levels and the average glucose values measured using the Continuous Glucose Monitoring system (CGMS) from baseline to the end of treatment (Day 84±3) were found to be -0.22%, -1.43 mg/dL, 2.55 mg/dL, and -19.14 mg/dL respectively indicating that Vildagliptin 100 mg Sustained Release Tablet administered once daily in patients with Type 2 diabetes mellitus who are not optimally controlled on metformin alone is beneficial for better patient compliance towards effective glycemic control while reducing the frequency of dosing.
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References
2. Das S, Gupta A, Bandyopadhyaya B, et al. Data on vildagliptin and vildagliptin plus metformin combina- tion in type-2 diabetes mellitus management Bioinforma- tion. 2021; 17(3):413.
3. Mohan V, Zargar A, Chawla M, et al. Efficacy of a combination of metformin and vildagliptin in comparison to metformin alone in type 2 diabetes mellitus: a multi- centre, retrospective, real-world evidence study Diabetes Metab Syndr Obes Targets Therapy. 2021; 14:2925.
4. Rizzo MR, Barbieri M, Marfella R, Paolisso G. Reduc- tion of oxidative stress and inflammation by blunting daily acute glucose fluctuations in patients with type 2 diabetes Diab Care. 2012; 35(10):2076-2082.
5. GR Sridhar, Kaushik Pandit, Sona Warrier, Ashish Birla. Sustained-Release Vildagliptin 100 mg in Type 2 Diabetes Mellitus: A Review. Cureus. 2023 May 18; 15(5):e39204.
6. Timmins P, Desai D, Chen W, et al.: Advances in mechanistic understanding of release rate control mechanisms of extended-release hydrophilic matrix tablets. Ther Del. 2016, 7:553-72.
7. Al-Hashimi N, Begg N, Alany RG, et al.: Oral modified release multiple-unit particulate systems: compressed pellets, microparticles and nanoparticles. Pharmaceutics. 2018, 10:176.
8. Conley R, Gupta SK, Sathyan G: Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr Med Resc Opin. 2006, 22:1879-92.
9. Verma RK, Krishna DM, Garg S: Formulation aspects in the development of osmotically controlled oral drug delivery systems. J Cont Rel. 2002, 79:7-27.
10. Sahoo CK, Sahoo NK, Rao SR, Sudhakar M, Satyanarayana K: A review on controlled porosity osmotic pump tablets and its evaluation. Bull Faculty Pharm. 2015, 53:195-205.
11. Aroda VR, Henry RR, Han J, Huang W, DeYoung MB, Darsow T, Hoogwerf BJ. Efficacy of GLP-1 receptor agonists and DPP-4 inhibitors: meta-analysis and systematic review. Clin Ther. 2012;34(6):1247–58.
12. Fakhoury WK, Lereun C, Wright D. A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes. Pharmacology. 2010;86(1):44–57.
13. Tang YZ, Wang G, Jiang ZH, Yan TT, Chen YJ, Yang M, Meng LL, Zhu YJ, Li CG, Li Z, Yu P. Efficacy and safety of vildagliptin, sitagliptin, and linagliptin as add-on therapy in Chinese patients with T2DM inadequately controlled with dual combination of insulin and traditional oral hypoglycemic agent. Diabetology & Metabolic Syndrome. 2015 Dec;7:1-9.
14. Matthews DR, Paldánius PM, Proot P, Chiang Y, Stumvoll M, Del Prato S. Glycaemic durability of an early combination therapy with vildagliptin and metformin versus sequential metformin monotherapy in newly diagnosed type 2 diabetes (VERIFY): a 5-year, multicentre, randomised, double-blind trial. The Lancet. 2019 Oct 26;394(10208):1519-29.