Cardiometabolic Effectiveness and Safety of SGLT2 Inhibitors in Patients with Type 2 Diabetes Mellitus at High Cardiovascular Risk: A Prospective Observational Study

Abstract

Background: Type 2 diabetes mellitus (T2DM) is associated with substantial cardiovascular and renal morbidity. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have emerged as an important therapeutic class because their effects extend beyond glycemic control to include reductions in body weight, blood pressure, cardiovascular events, heart-failure outcomes and progression of chronic kidney disease.

Objective: To evaluate the cardiometabolic effectiveness and safety of SGLT2 inhibitors among adults with T2DM and cardiovascular risk factors in routine clinical practice.

Materials and Methods: This prospective observational study will include adults aged ≥18 years with established T2DM, at least one cardiovascular risk factor and a prescription for an SGLT2 inhibitor as part of routine clinical care. Participants will be evaluated at baseline, 12 weeks and 24 weeks. The primary outcome will be change in glycated hemoglobin (HbA1c) from baseline to 24 weeks. Secondary outcomes will include fasting blood glucose, postprandial blood glucose, body weight, body mass index, systolic and diastolic blood pressure, lipid profile, serum creatinine, estimated glomerular filtration rate, treatment persistence and adverse drug reactions.

Results: Patient-level study results are pending completion of recruitment, follow-up and statistical analysis. Results will be reported as changes in glycemic, anthropometric, cardiovascular, lipid and renal parameters and as frequencies of adverse drug reactions.

Conclusion: This prospective observational study is designed to provide real-world evidence regarding the effectiveness and safety of SGLT2 inhibitors among patients with T2DM at increased cardiovascular risk. The results may help characterize their clinical pharmacology and pharmacovigilance profile in a tertiary-care medical-college setting.