Comparative Study between combination therapy Empagliflozin–Sitagliptin and Empagliflozin–Alogliptin in addition to Metformin assessing the hypoglycemic effect on patients diagnosed with malignancy and poorly controlled Type 2 diabetes mellitus as comorbidity

Abstract

Background: Type 2 diabetes mellitus (T2DM) in patients with malignancy poses unique therapeutic challenges, necessitating effective and safe combination therapies. This study compared the efficacy and safety of empagliflozin–sitagliptin–metformin versus empagliflozin–alogliptin–metformin in poorly controlled T2DM with coexisting cancer.

Methods: Prospective, randomized, open-label clinical trial of 12 weeks was performed in 120 patients with T2DM and controlled malignancy. Two groups were randomized: Group A, who received empagliflozin 10 mg combined with sitagliptin 100 mg along with metformin, and Group B, who received empagliflozin 10 mg combined with alogliptin 25 mg along with metformin. Primary endpoint was HbA1c change; secondary endpoints were fasting plasma glucose (FPG), postprandial glucose (PPG), body weight, lipid profile, and adverse events. Data were examined using repeated-measures ANOVA and independent t-tests with p<0.05 being significant.

Results: Baseline demographics were similar between groups. At 12 weeks, Group A had a larger mean decrease in HbA1c (−1.4% ± 0.3) than Group B (−1.1% ± 0.4; p=0.02). FPG and PPG also dropped significantly lower in Group A (−37.7 mg/dL and −54.1 mg/dL, respectively) than Group B (−31.7 mg/dL and −46.2 mg/dL; p<0.05). Both regimens were tolerated without difficulty, with minimal hypoglycemia and urinary tract infection being the only adverse events noted, and no deterioration of malignancy symptoms.

Conclusion: Empagliflozin–sitagliptin–metformin yielded better glycemic control than empagliflozin–alogliptin–metformin in T2DM patients with malignancy without compromising safety. This combination may be a more potent treatment option for managing complex diabetic populations.