Comparative assessment of treatment outcomes of empagliflozin add-on metformin and sitagliptin add-on metformin therapies in uncontrolled type 2 diabetes mellitus: findings from an observational study in Pakistan.

Background: Uncontrolled type 2 diabetes mellitus warrant the utilization of different combination antidiabetic therapies, however, the addition of these newer agents as add-on therapy increases the risk of side effects and needs to be further investigated in terms of their risk to benefit to the patient. Therefore, the current study aims to evaluate the clinical and safety outcomes in patients taking empagliflozin and Sitagliptin in addition to metformin.

Method: A cross-sectional study was conducted using a non-probability consecutive sampling technique to gather data at the Diabetes and Foot Care Clinic in Abbottabad from July 2023 to December 2023. This is an exploratory observational study in which a total of 155 study participants were selected and divided into two groups: Group A, treated with Sitagliptin add-on Metformin (n = 79), and Group B, treated with Empagliflozin add-on Metformin (n = 76), Biochemical parameters (HbA1c, serum creatinine) were collected and eGFR was calculated at baseline and after a 3-month follow-up. All statistical analyses were performed using IBM SPSS version 23.

Results: Among the participant's majority (53.5%) were males whereas the mean age of the participants was 51.7 ± 10.5 years. Baseline HbA1c and serum creatinine of all the patients were found to be 9.5 ± 1.8% and 1.02 ± 0.2 mg/dL respectively. There was a statistically significant decrease in mean HbA1c values in both the groups at baseline and follow-up (p < 0.001) whereas both the groups were found to be similar in their ability to reduce HbA1c (p = 0.25). Furthermore, there was a statistically significant decrease in serum creatinine values in both the groups at baseline and follow-up (p = 0.002) whereas Empagliflozin add-on Metformin was found to have more ability to reduce serum creatinine (p = 0.01) as compared to Sitagliptin add-on Metformin (p = 0.06). As a result, Empagliflozin add-on Metformin improved the patients' eGFR significantly (p = 0.001).

Conclusion: Empagliflozin as add on therapy in uncontrolled T2DM provided improvements in patients HbA1c, serum creatinine, and eGFR hence improving overall clinical outcomes and patient safety.