Effects of Dapagliflozin on Obese Patients With Type 2 Diabetes: A Prospective Observational Study From Bangladesh.

OBJECTIVE

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder frequently associated with obesity, leading to increased risks of cardiovascular and renal complications. Dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, has emerged as a promising therapeutic agent for improving glycemic control and promoting weight reduction. However, evaluating its safety and efficacy in obese T2DM patients remains essential, particularly in real-world clinical settings. This study aimed to assess the safety and efficacy of dapagliflozin in obese patients with type 2 diabetes mellitus (T2DM) by assessing adverse event profiles and the reduction in HbA1c levels over the treatment period.

METHODOLOGY

This 12-month prospective, multicenter observational study was conducted from April 2023 to April 2024 at BIRDEM (Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders) General Hospital, Dhaka, and affiliated healthcare centers in Bangladesh. One thousand five hundred patients with type 2 diabetes mellitus and a body mass index (BMI) ≥30 kg/m² were consecutively enrolled from outpatient clinics. Eligibility was based on a confirmed diagnosis of type 2 diabetes and the recent initiation of dapagliflozin therapy. Patients received 5 mg or 10 mg of dapagliflozin daily, either as monotherapy or in combination with other antidiabetic agents. Physicians made all treatment decisions independently as part of routine clinical care. Clinical and laboratory data were extracted from medical records using a standardized case record form. Outcomes included changes in glycemic and lipid parameters at baseline, three, six, and 12 months, and the frequency of adverse events. Statistical analyses were performed using IBM SPSS Statistics for Windows, version 25 (IBM Corp., Armonk, NY), with statistical significance set at p < 0.05.

RESULTS

The study showed a statistically significant reduction in mean glycated hemoglobin levels from 8.1 ± 1.7 at baseline to 7.3 ± 1.4 after six months of treatment (p<0.0001). Adverse events were reported in 240 (16%) patients, with the most common being 90 (37.5%) cases of fatigue and hypoglycemia each. Urinary tract infection was observed in 60 (25%) cases, vulvovaginal pruritus and dysuria in 30 (12.5%) cases. A total of 30 (12.5%) patients developed diabetic ketoacidosis (DKA), primarily those with a long-standing history of diabetes (≥10 years) and prior hypertension.

CONCLUSION

Dapagliflozin appears to be an effective therapeutic option for the management of type 2 diabetes in obese individuals, contributing to improvements in glycemic control and metabolic parameters. When administered alone or in combination with other antidiabetic agents, it was associated with favorable clinical outcomes and an acceptable safety profile, supporting its utility in routine clinical practice.