Efficacy and Safety of Dapagliflozin as Adjunct Therapy in Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea
DOI:
https://doi.org/10.48165/ajm.2026.9.02.34Keywords:
Dapagliflozin, type 2 diabetes mellitus, metformin, sulfonylurea, glycaemic control, HbA1c, adverse drug reactionsAbstract
Background: Achieving adequate glycaemic control remains challenging in patients with type 2 diabetes mellitus (T2DM) receiving metformin and sulfonylurea. Dapagliflozin offers an additional glucose-lowering mechanism through inhibition of renal sodium-glucose cotransporter-2.
Aim: To evaluate the efficacy and safety of dapagliflozin as adjunct therapy in patients with T2DM inadequately controlled on metformin and sulfonylurea.
Materials and Methods: This prospective observational study included 147 patients with inadequately controlled T2DM receiving metformin and sulfonylurea. Dapagliflozin 10 mg once daily was added to the existing treatment regimen. Changes in HbA1c, fasting and postprandial blood glucose, body weight, BMI, blood pressure and laboratory safety parameters were assessed during follow-up. Adverse drug reactions were also recorded. Statistical significance was set at p
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References
1. American Diabetes Association Professional Practice Committee. (2025). Pharmacologic approaches to glycemic treatment: Standards of Care in Diabetes—2025. Diabetes Care, 48(Suppl. 1), S181–S206. https://doi.org/10.2337/dc25-S009
2. American Diabetes Association Professional Practice Committee. (2025). Cardiovascular disease and risk management: Standards of Care in Diabetes—2025. Diabetes Care, 48(Suppl. 1), S207–S238. https://doi.org/10.2337/dc25-S010
3. Davies, M. J., Aroda, V. R., Collins, B. S., Gabbay, R. A., Green, J., Maruthur, N. M., et al. (2022). Management of hyperglycemia in type 2 diabetes, 2022. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care, 45(11), 2753–2786. https://doi.org/10.2337/dci22-0034
4. Mathieu, C., Ranetti, A. E., Li, D., Ekholm, E., Cook, W., Hirshberg, B., et al. (2015). Randomized, double-blind, phase 3 trial of triple therapy with dapagliflozin add-on to saxagliptin plus metformin in type 2 diabetes. Diabetes Care, 38(11), 2009–2017. https://doi.org/10.2337/dc15-0779
5. Matthaei, S., Bowering, K., Rohwedder, K., Grohl, A., & Parikh, S. (2015). Dapagliflozin improves glycemic control and reduces body weight as add-on therapy to metformin plus sulfonylurea: A 24-week randomized, double-blind clinical trial. Diabetes Care, 38(3), 365–372. https://doi.org/10.2337/dc14-0666
6. Wilding, J. P. H., Woo, V., Soler, N. G., Pahor, A., Sugg, J., Rohwedder, K., et al. (2012). Long-term efficacy of dapagliflozin in patients with type 2 diabetes mellitus receiving high doses of insulin: A randomized trial. Annals of Internal Medicine, 156(6), 405–415. https://doi.org/10.7326/0003-4819-156-6-201203200-00003
7. Bailey, C. J., Gross, J. L., Pieters, A., Bastien, A., & List, J. F. (2010). Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with metformin: A randomised, double-blind, placebo-controlled trial. The Lancet, 375(9733), 2223–2233. https://doi.org/10.1016/S0140-6736(10)60407-2
8. Ferrannini, E., Ramos, S. J., Salsali, A., Tang, W., & List, J. F. (2010). Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: A randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care, 33(10), 2217–2224. https://doi.org/10.2337/dc10-0612
9. Strojek, K., Yoon, K. H., Hruba, V., Elze, M., Langkilde, A. M., & Parikh, S. (2011). Effect of dapagliflozin in patients with type 2 diabetes who have inadequate glycaemic control with glimepiride: A randomized, 24-week, double-blind, placebo-controlled trial. Diabetes, Obesity and Metabolism, 13(10), 928–938. https://doi.org/10.1111/j.1463-1326.2011.01434.x
10. Nauck, M. A., Del Prato, S., Meier, J. J., Durán-García, S., Rohwedder, K., Elze, M., et al. (2011). Dapagliflozin versus glipizide as add-on therapy in patients with type 2 diabetes who have inadequate glycemic control with metformin: A randomized, 52-week, double-blind, active-controlled noninferiority trial. Diabetes Care, 34(9), 2015–2022. https://doi.org/10.2337/dc11-0606
11. Wiviott, S. D., Raz, I., Bonaca, M. P., Mosenzon, O., Kato, E. T., Cahn, A., et al. (2019). Dapagliflozin and cardiovascular outcomes in type 2 diabetes. The New England Journal of Medicine, 380(4), 347–357. https://doi.org/10.1056/NEJMoa1812389
12. McMurray, J. J. V., Solomon, S. D., Inzucchi, S. E., Køber, L., Kosiborod, M. N., Martinez, F. A., et al. (2019). Dapagliflozin in patients with heart failure and reduced ejection fraction. The New England Journal of Medicine, 381(21), 1995–2008. https://doi.org/10.1056/NEJMoa1911303
13. Heerspink, H. J. L., Stefánsson, B. V., Correa-Rotter, R., Chertow, G. M., Greene, T., Hou, F. F., et al. (2020). Dapagliflozin in patients with chronic kidney disease. The New England Journal of Medicine, 383(15), 1436–1446. https://doi.org/10.1056/NEJMoa2024816
14. Solomon, S. D., McMurray, J. J. V., Claggett, B., de Boer, R. A., DeMets, D., Hernandez, A. F., et al. (2022). Dapagliflozin in heart failure with mildly reduced or preserved ejection fraction. The New England Journal of Medicine, 387(12), 1089–1098. https://doi.org/10.1056/NEJMoa2206286
15. Zelniker, T. A., Wiviott, S. D., Raz, I., Im, K., Goodrich, E. L., Furtado, R. H. M., et al. (2019). SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: A systematic review and meta-analysis of cardiovascular outcome trials. The Lancet, 393(10166), 31–39. https://doi.org/10.1016/S0140-6736(18)32590-X
