Comparison of Empagliflozin Versus Vildagliptin in Combination with Metformin in Individuals Diagnosed with Type II Diabetes Mellitus
DOI:
https://doi.org/10.70749/ijbr.v3i7.2091Keywords:
: Blood Glucose Level, Dyslipidemia, Empagliflozin, Metformin, Total cholesterol, Type II Diabetes Mellitus, Vildagliptin.Abstract
Objective: To compare the outcome of combination of vildagliptin with metformin empagliflozin with metformin in individuals diagnosed with type II diabetes mellitus Study design: Randomized controlled trial. Place and duration of study: Department of Medicine, AIMS, Muzaffarabad, AJK from 21 January, 2025 to 15 June, 2025. Methodology: Three hundred and twenty individuals, fulfilled the selection criteria, were included. Then individuals were randomly allocated in 02 groups. In group-A, individuals were prescribed once daily oral empagliflozin plus metformin at the dose of 10/1000 mg. In group-B, individuals were prescribed once daily oral vildagliptin plus metformin at the dose of 50/1000 mg. At baseline and after 12 weeks of follow-up, HbA1c, fasting blood glucose level and lipid profile were assessed. Data was analyzed in SPSS v.25.0, with P–value ≤ 0.05 as significant. Results: In this trial, we enrolled total 320 individuals and randomized them in two equal group. The mean age of individuals enrolled in Group-A was 56.16 ± 9.57 years as well as in Group-B was 57.86 ± 9.33 years. In Group-A, there were 94 (58.8%) men and 66 (41.3%) women. In Group-B, there were 79 (49.4%) men and 81 (50.6%) women. The median change in HBA1c level in Group-A that was 0.80 (IQR: 0.78) % and in Group-B was 1.00 (IQR: 0.80) %. The median change in HBA1 was more achieve in Group-B, however the difference was insignificant (p>0.05). In Group-A, the median change in fasting blood glucose level of 20.00 (IQR: 37.50) vs. 25.00 (IQR: 46.75) mg/dl (p>0.05). The median change in total cholesterol level was 20.00 (IQR: 38.00) mg/dl vs. 28.00 (IQR: 31.00) mg/dl (p<0.05) and median change in triglycerides level was 28.00 (IQR: 40.00) vs. 29.00 (IQR: 79.00) mg/dl (p>0.05). Conclusion: The change in glycemic level and lipid profile of diabetic individuals is similar whether vildagliptin is given or empagliflozin is given in combination with metformin.
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1. Khunti, K., Zaccardi, F., Amod, A., Aroda, V. R., Aschner, P., Colagiuri, S., Mohan, V., & Chan, J. C. (2024). Glycaemic control is still central in the hierarchy of priorities in type 2 diabetes management. Diabetologia, 68(1), 17-28.
https://doi.org/10.1007/s00125-024-06254-w
2. Paldánius, P. M. (2020). Evaluating the evidence behind the novel strategy of early combination from vision to implementation. Diabetes & Metabolism Journal, 44(6), 785-801.
https://doi.org/10.4093/dmj.2020.0179
3. Foretz, M., Guigas, B., & Viollet, B. (2019). Understanding the glucoregulatory mechanisms of metformin in type 2 diabetes mellitus. Nature Reviews Endocrinology, 15(10), 569-589.
https://doi.org/10.1038/s41574-019-0242-2
4. Lee, S., Park, S., & Choi, C. S. (2022). Insulin resistance: From mechanisms to therapeutic strategies. Diabetes & Metabolism Journal, 46(1), 15-37.
https://doi.org/10.4093/dmj.2021.0280
5. Pathan, M. F., Akter, N., Selim, S., Saifuddin, M., Qureshi, N. K., Kamrul-Hasan, A., Hannan, M. A., Ahmed, M. A., Mustari, M., & Chakraborty, A. K. (2022). Efficacy and safety of Empagliflozin in patients with type 2 diabetes mellitus fasting during Ramadan: A real-world study from Bangladesh. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy, 15, 4011-4021.
https://doi.org/10.2147/dmso.s380544
6. Boehringer Ingelheim Pharmaceuticals. Jardiance (empagliflozin) tablets; prescribing information 2022 [cited 2023].
7. Mone, P., Lombardi, A., Gambardella, J., Pansini, A., Macina, G., Morgante, M., Frullone, S., & Santulli, G. (2022). Empagliflozin improves cognitive impairment in frail older adults with type 2 diabetes and heart failure with preserved ejection fraction. Diabetes Care, 45(5), 1247-1251.
https://doi.org/10.2337/dc21-2434
8. Alsalim, W., Persson, M., & Ahrén, B. (2018). Different glucagon effects during DPP‐4 inhibition versus SGLT‐2 inhibition in metformin‐treated type 2 diabetes patients. Diabetes, Obesity and Metabolism, 20(7), 1652-1658.
https://doi.org/10.1111/dom.13276
9. Son, C., Makino, H., Kasahara, M., Tanaka, T., Nishimura, K., Taneda, S., Nishimura, T., Kasama, S., Ogawa, Y., Miyamoto, Y., & Hosoda, K. (2021). Comparison of efficacy between dipeptidyl peptidase-4 inhibitor and sodium–glucose cotransporter 2 inhibitor on metabolic risk factors in Japanese patients with type 2 diabetes mellitus: Results from the cantabile study. Diabetes Research and Clinical Practice, 180, 109037.
https://doi.org/10.1016/j.diabres.2021.109037
10. Gautam, K., Tripathy, R., Meher, D., & Sahoo, J. P. (2023). Dapagliflozin versus Vildagliptin as an adjuvant to metformin in patients with type 2 diabetes mellitus: A randomized, open-label study. Cureus.
https://doi.org/10.7759/cureus.38200
11. Khan, A., Khan, I. A., Abidi, H., & Ahmed, M. (2022). Comparison of empagliflozin and vildagliptin for efficacy and safety in type 2 diabetes mellitus in the Pakistani population. Frontiers in Endocrinology, 13.
https://doi.org/10.3389/fendo.2022.926633
12. Bolli, G., Dotta, F., Colin, L., Minic, B., & Goodman, M. (2009). Comparison of vildagliptin and pioglitazone in patients with type 2 diabetes inadequately controlled with metformin. Diabetes, Obesity and Metabolism, 11(6), 589-595.
https://doi.org/10.1111/j.1463-1326.2008.01023.x
13. González-Ortiz, M., Sánchez-Peña, M. J., González-Ortiz, L. J., Robles-Cervantes, J. A., García-Ortega, Y. E., Gómez-Gaitán, E. A., Pérez-Rubio, K. G., & Martínez-Abundis, E. (2013). Effect of Vildagliptin on glucose and insulin concentrations during a 24-Hour period in type 2 diabetes patients with different ranges of baseline hemoglobin A1c levels. Diabetes Technology & Therapeutics, 15(7), 564-568.
https://doi.org/10.1089/dia.2013.0020
14. Rosenstock, J., Seman, L. J., Jelaska, A., Hantel, S., Pinnetti, S., Hach, T., & Woerle, H. J. (2013). Efficacy and safety of empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, as add‐on to metformin in type 2 diabetes with mild hyperglycaemia. Diabetes, Obesity and Metabolism, 15(12), 1154-1160.
https://doi.org/10.1111/dom.12185
15. Ferrannini, E., Seman, L., Seewaldt‐Becker, E., Hantel, S., Pinnetti, S., & Woerle, H. J. (2013). AP hase IIb, randomized, placebo‐controlled study of the SGLT2 inhibitor empagliflozin in individuals with type 2 diabetes. Diabetes, Obesity and Metabolism, 15(8), 721-728.
https://doi.org/10.1111/dom.12081
16. Dejager, S., Razac, S., Foley, J., & Schweizer, A. (2007). Vildagliptin in drug-naïve patients with type 2 diabetes: A 24-Week, double-blind, randomized, placebo-controlled, multiple-dose study. Hormone and Metabolic Research, 39(3), 218-223.
https://doi.org/10.1055/s-2007-970422
17. Pan, C. Y., & Wang. (2013). Profile of vildagliptin in type 2 diabetes: Efficacy, safety, and patient acceptability. Therapeutics and Clinical Risk Management, 247.
https://doi.org/10.2147/tcrm.s30071
18. Sakamoto, M., Nishimura, R., Irako, T., Tsujino, D., Ando, K., & Utsunomiya, K. (2012). Comparison of vildagliptin twice daily vs. sitagliptin once daily using continuous glucose monitoring (CGM): Crossover pilot study (J-VICTORIA study). Cardiovascular Diabetology, 11(1), 92.
https://doi.org/10.1186/1475-2840-11-92
19. Liu, S., Lee, C., Chuang, S., Sun, F., & Zeng, Y. (2021). Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study. Diabetes & Metabolism, 47(3), 101184.
https://doi.org/10.1016/j.diabet.2020.08.001
20. Del Prato, S., Rosenstock, J., Garcia‐Sanchez, R., Iqbal, N., Hansen, L., Johnsson, E., Chen, H., & Mathieu, C. (2018). Safety and tolerability of dapagliflozin, saxagliptin and metformin in combination: Post-hoc analysis of concomitant add-on versus sequential add-on to metformin and of triple versus dual therapy with metformin. Diabetes, Obesity and Metabolism, 20(6), 1542-1546.
https://doi.org/10.1111/dom.13258
21. Wang, J., Lu, Y., Min, X., Yuan, T., Wei, J., & Cai, Z. (2021). The association between metformin treatment and outcomes in type 2 diabetes mellitus patients with heart failure with preserved ejection fraction: A retrospective study. Frontiers in Cardiovascular Medicine, 8.
https://doi.org/10.3389/fcvm.2021.648212
22. Kumar, S. (2021). Comparison of safety and efficacy of glimepiride-metformin and vildagliptin- Metformin treatment in newly diagnosed type 2 diabetic patients. Indian Journal of Endocrinology and Metabolism, 25(4), 326-331.
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