The BRIDGE-DS Study: Improved Glycemic Control and Renal Function in Type 2 Diabetes Mellitus Patients Using the Fixed-Dose Combination of Dapagliflozin and Sitagliptin

Abstract

Background: Chronic kidney disease (CKD) is characterized by persistent or intermittent albuminuria and a declining glomerular filtration rate (GFR). CKD affects 20-40% of patients with diabetes globally, with significant impacts on health outcomes and healthcare costs. Type 2 diabetes mellitus (T2DM) patients with poor glycemic control are at higher risk of developing CKD, leading to severe complications, including end-stage kidney disease (ESRD).

Methods: A retrospective, multicenter, observational study was conducted using a case-based questionnaire survey to collect data anonymously from diabetologists and endocrinologists across India. The study included T2DM patients with CKD who received a fixed-dose combination (FDC) therapy of dapagliflozin and sitagliptin (D/S). Data were collected digitally and analyzed using SPSS^® Version 23.0 software.

Results: Data from 510 patients were collected, comprising 67.6% males and 32.4% females. The median age of the patient cohort was 56 years. After 3 months of FDC D/S treatment, significant reductions in glycated hemoglobin (HbA_1c) levels from 9.00% to 7.50%, along with reductions in fasting plasma glucose (FPG) and post-prandial glucose (PPG) levels, were noted. Serum creatinine levels decreased by 0.37 mg/dL, while estimated glomerular filtration rate (eGFR) values improved from 83.83 to 84.00 mL/min/1.73 m², indicating a potential improvement in renal function. Adverse events (AEs) included urinary tract infections (UTIs), dehydration, hypoglycemia, and genital mycotic infections.

Conclusion: The study demonstrated that FDC D/S therapy is effective and safe for the management of T2DM and CKD, showing significant improvements in glycemic control and renal function. The combination therapy resulted in notable reductions in HbA_1c, FPG, and PPG, along with improved eGFR values, underscoring its renoprotective effects. Despite some AEs, the findings support the use of D/S in combination therapy for patients with T2DM and CKD. However, further research is required to explore the long-term effects and optimal dosing strategies of this drug combination.