Observational Study to Assess Safety of Sglt2 Inhibitors in Type 2 Diabetes Mellitus Patients in Clinical Settings

Abstract

Introduction: Type 2 diabetes mellitus (T2DM) poses a significant global burden. Sodium-glucose co-transporter 2 (SGLT2) inhibitors have emerged as promising agents for glycemic control with additional cardiovascular and renal benefits. However, real-world safety data remain limited.

Objectives: To assess the safety profile of SGLT2 inhibitors in Indian clinical settings through active monitoring of adverse events in patients with T2DM.

Methods: A multicentric, prospective observational study was conducted at four hospitals in Pune, Maharashtra and one hospital at Trichy, Tamilandu in India. A total of 500 patients with T2DM receiving SGLT2 inhibitors alone or in combination with other antidiabetic drugs were enrolled and followed for 26 weeks. Adverse events were actively monitored and evaluated. The baseline and week 26 weeks HbA1c were monitored to check the effectiveness of treatment.

Results: The most frequently reported adverse event was genital mycotic infection (9.4%), followed by urinary tract infection (5.2%). Other AEs included ketoacidosis (2.0%), hypotension (1.8%), hypovolemia (1.4%), dehydration (1.2%), and hypoglycemia (1.0%). There was a significant mean reduction in HbA1c from 8.93% to 7.36% over 26 weeks (Δ = 1.57%).

Conclusions: This real-world study confirms that SGLT2 inhibitors are effective in lowering HbA1c in Indian T2DM patients, with an overall acceptable safety profile. While genital and urinary infections were the most common adverse events, serious events like ketoacidosis and hypotension were rare. These findings support the continued use of SGLT2 inhibitors with appropriate monitoring in routine clinical practice.