Efficacy and Safety of Dapagliflozin in Type 2 Diabetics With Stage 3A Chronic Kidney Disease

Abstract

Objective: The objective of this study was to evaluate the efficacy and safety of Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, in patients with chronic kidney disease stage 3A (CKD 3A) and inadequately controlled Type 2 Diabetes Mellitus (T2DM).

Methodology: This randomized controlled trial was conducted at Pakistan Institute of Medical Sciences (PIMS), Islamabad, and included 196 patients with T2DM and CKD 3A (estimated glomerular filtration rate [eGFR] 45–60 ml/min/m²) with inadequate glycemic control (HbA1c 7.0%–11.0%). Patients were randomly assigned to either Dapagliflozin 10 mg/day plus standard care (Group A) or placebo plus standard care (Group B). After 24 weeks of treatment, HbA1c, eGFR, and hypoglycemic events were assessed. Efficacy was measured by changes in HbA1c, while safety was evaluated based on changes in eGFR and the occurrence of hypoglycemic episodes.

Results: After 24 weeks, Group A demonstrated a significant reduction in HbA1c levels, with a mean decrease from 8.2% (± 0.71) to 7.7% (± 0.68) (p = 0.002). In contrast, Group B showed no significant change, with a mean HbA1c reduction from 7.58% (± 0.72) to 7.52% (± 0.38). The eGFR in Group A declined slightly from 52.14 ml/min/m² (± 4.8) to 51.27 ml/min/m² (± 5.8), whereas in Group B, a more pronounced decline was observed from 50.8 ml/min/m² (± 6.7) to 47.6 ml/min/m² (± 6.0) (p < 0.000). Hypoglycemic episodes occurred in 5% of patients in Group A and 6% in Group B, with no significant difference between the groups.

Conclusion: Dapagliflozin effectively reduced HbA1c levels in patients with T2DM and CKD 3A without significantly affecting eGFR or increasing the risk of hypoglycemic events. It can be considered a safe and effective therapeutic option for this patient population.

Keywords: Type 2 Diabetes Mellitus, SGLT2 Inhibitor, Dapagliflozin, Chronic Kidney Disease Stage 3A, HbA1c, eGFR, Hypoglycemia