ABSTRACT
Background: Type 2 diabetes mellitus (T2DM) management remains the challenge in spite of advances in pharmacotherapy. Sodium-glucose co-transporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors have emerged as effective treatment options. However, their combination therapy’s efficacy and safety require further evaluation.

Aim: This research intended to assess Comparison of Efficacy and Safety of Empaglifozin 10mg plus Linagliptin 5mg in Management of Type 2 Diabetes Combination Treatment in addition to standard Treatment vs. Standard Treatment alone
Methods: A prospective, single-center study was conducted from May 2023 to April 2024, involving 120 participants identified through type 2 diabetes. Patients were randomly allotted to either combination therapy group (Empaglifozin 10mg  plus Linagliptin 5mg  Combination Treatment in addition to standard Treatment) or a control group receiving standard therapy. Glycemic control, measured by HbA1c levels, was the primary efficacy endpoint. Secondary endpoints included changes in body weight, blood pressure, lipid profile, and incidence of adverse events related to the therapies.
Results: The research population comprised of 120 participants (mean age ± SD, 55 ± 8 years; 60% male). At baseline, there were no substantial variances in demographic and medical features among sets. After 12 months of treatment, the combination therapy group demonstrated a statistically significant reduction in mean HbA1c levels compared to the control group (p < 0.001). Participants in combination therapy group also experienced beneficial changes in body weight, blood pressure, and lipid profile (p < 0.05 for entirely comparisons). Adverse events were comparable among sets, with no significant safety concerns identified.
Conclusion: Combination therapy with SGLT2 inhibitors and DPP-4 inhibitors in addition to standard therapy proved to be more effective in improving glycemic control and associated metabolic parameters compared to standard treatment alone in individuals having type 2 diabetes. The regimen was well-tolerated having very comparable safety profile. These findings support use of SGLT2 inhibitor plus DPP-4 inhibitor combination therapy as very viable option for managing type 2 diabetes, emphasizing its potential to optimize treatment outcomes.
Keywords: Type 2 diabetes, SGLT2 inhibitors, DPP-4 inhibitors, combination therapy, glycemic control, safety and efficacy.