Akhond Somya Binte, Bupasha Jamila, Jannat Gull E, Sharmin Lubna, Sumon Md Nazmul Hossain, Akhter Ruma, Mahbub Fahim
Department of Respiratory Medicine, Mukti Hospital, Cumilla, BGD.
Department of Surgery, Enam Medical College and Hospital, Dhaka, BGD.
Cureus. 2025 Aug 4;17(8):e89360. doi: 10.7759/cureus.89360. eCollection 2025 Aug.
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.
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.
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.
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.
2型糖尿病（T2DM）是一种常与肥胖相关的慢性代谢紊乱疾病，会增加心血管和肾脏并发症的风险。达格列净是一种钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，已成为改善血糖控制和促进体重减轻的一种有前景的治疗药物。然而，评估其在肥胖T2DM患者中的安全性和有效性仍然至关重要，尤其是在实际临床环境中。本研究旨在通过评估不良事件谱以及治疗期间糖化血红蛋白（HbA1c）水平的降低情况，来评估达格列净在肥胖2型糖尿病（T2DM）患者中的安全性和有效性。
这项为期12个月的前瞻性、多中心观察性研究于2023年4月至2024年4月在达卡的BIRDEM（孟加拉国糖尿病、内分泌和代谢疾病研究与康复研究所）总医院及孟加拉国的附属医疗中心进行。从门诊连续招募了1500例2型糖尿病且体重指数（BMI）≥30kg/m²的患者。入选标准基于2型糖尿病的确诊以及近期开始使用达格列净治疗。患者每天接受5mg或10mg达格列净治疗，可作为单药治疗或与其他抗糖尿病药物联合使用。作为常规临床护理的一部分，医生独立做出所有治疗决策。使用标准化病例记录表从病历中提取临床和实验室数据。结果包括基线、3个月、6个月和12个月时血糖和血脂参数的变化以及不良事件的发生频率。使用IBM SPSS Statistics for Windows 25版（IBM公司，纽约州阿蒙克）进行统计分析，设定统计学显著性为p < 0.05。
研究显示，治疗6个月后，平均糖化血红蛋白水平从基线时的8.1±1.7显著降至7.3±1.4（p<0.0001）。240例（16%）患者报告了不良事件，最常见的是疲劳和低血糖各90例（37.5%）。观察到60例（25%）发生尿路感染，30例（12.5%）发生外阴阴道瘙痒和排尿困难。共有30例（12.5%）患者发生糖尿病酮症酸中毒（DKA），主要是那些有长期糖尿病病史（≥10年）和既往高血压的患者。
达格列净似乎是肥胖个体2型糖尿病管理的一种有效治疗选择，有助于改善血糖控制和代谢参数。单独使用或与其他抗糖尿病药物联合使用时，它具有良好的临床结局和可接受的安全性，支持其在常规临床实践中的应用。
