Effectiveness and Safety of Fixed-Dose Empagliflozin/Linagliptin Combination in Type 2 Diabetes Mellitus: Real-World Evidence From Bangladesh.

backgroundType 2 diabetes mellitus (T2DM) presents a growing health burden globally and in Bangladesh, where control rates remain suboptimal. Fixed-dose combinations (FDCs) integrating agents with complementary mechanisms, such as empagliflozin and linagliptin, may enhance glycemic control, reduce cardiovascular risk factors, and improve adherence. This study aimed to evaluate the real-world effectiveness and safety of empagliflozin-linagliptin FDC over 24 weeks in adult T2DM patients in Bangladesh.

methodsThis prospective, multi-center, open-label, real-world observational cohort study was conducted across 10 outpatient centers in routine clinical practice in Bangladesh and enrolled 321 adults with T2DM who were either treatment-naïve or inadequately controlled on oral antidiabetic drugs. Participants received once daily empagliflozin 10 mg or 25 mg, plus linagliptin 5 mg. Clinical visits were conducted at baseline, week 6, week 12, and week 24. Primary endpoints comprised changes in HbA1c and fasting plasma glucose (FPG). Secondary measures included proportions achieving HbA1c <7%, and changes in weight, blood pressure, lipid profile, renal function, and liver enzymes. Safety was assessed via recorded adverse events and treatment discontinuation rates.

resultsAt 24 weeks, mean HbA1c decreased significantly from 9.82 ± 1.01% to 6.29 ± 0.76% (mean change: -3.55%, n = 303, p<0.001). FPG dropped from 13.27 ± 2.66 mmol/L to 6.31 ± 0.70 mmol/L (mean change: -6.96 mmol/L, n = 321, p < 0.001), and 225 (74.3%) attained HbA1c <7%. There were significant reductions in mean weight (-7.17 kg), systolic blood pressure (-14.97 mmHg), and diastolic blood pressure (-2.84 mmHg) (n = 321, p < 0.001 for all). Among subsets, total cholesterol, low-density lipoprotein (LDL), triglycerides, serum creatinine, and serum glutamic pyruvic transaminase (SGPT) levels improved, with estimated glomerular filtration rate (eGFR) increasing significantly (p < 0.05). No serious adverse events or study withdrawals occurred; minor adverse events (AEs) included transient hypoglycemia in one participant (<1%), anorexia or nausea in 10 (≤3.1%), urinary tract infections in two (~0.6%), dysuria in two (<1%), and dizziness in two (<1%).

conclusionIn this real-world observational cohort of Bangladeshi adults with T2DM, treatment with the empagliflozin-linagliptin FDC was associated with improvements in glycemic control, cardiometabolic benefits, and renal improvements over 24 weeks, with a favorable short-term safety profile. These findings indicate that the FDC was associated with significant improvements in this real-world cohort, providing supportive evidence for its utility.