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

Abstract

Objective: To evaluate the efficacy and safety of Dapagliflozin that is a sodium-glucose co-transporter 2 (SGLT2) inhibitor in patients with chronic kidney disease stage 3A (CKD 3A) and inadequately managed Type 2 Diabetes Mellitus (T2DM).

Methodology: The randomized controlled trial study was conducted at PIMS Islamabad from January 2022 to December 2022, included 196 patients with T2DM and CKD 3A (eGFR 45-60 ml/min/m²) with inadequate glycemic control (HbA1c 7.0%-11.0%). Patients were assigned to Dapagliflozin 10 mg/day (Group A) and placebo plus standard care (Group B), randomly. After 24 weeks of treatment the HbA1c, eGFR and hypoglycemic events were measured at baseline. Change in HbA1c was used to measure efficacy and safety was evaluated by eGFR changes and hypoglycemic episodes.

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

Conclusion: Dapagliflozin effectively reduced HbA1c with no significant impact on eGFR or hypoglycemic events. It can be considered a safe and efficacious treatment option for T2DM patients with CKD 3A.