Clinical Evaluation of Dapagliflozin in Patients with Poor Glycaemic Control in the Routine Clinical Setting

Background: Published clinical trials of SGLT2 inhibitors have typically recruited participants with modest elevations of HbA1c. Our aim was to evaluate the efficacy of dapagliflozin in patients with uncontrolled glycaemia in a routine clinic setting where patients are taking a range of other therapies. Methods: A prospective observational evaluation over six months. Dapagliflozin was added to concomitant medications including insulin and glucagon like peptide-1 (GLP-1) agonists. Clinical outcomes were examined in patients with a baseline HbA1c ≥ 9.5% (80 mmol/mol) and an HbA1c<9.5% (80 mmol/mol). Results: Data was available on 166 patients (65 HbA1c<9.5%; 101 HbA1c ≥ 9.5%). All showed significant reductions in HbA1c, body weight, blood pressure and insulin dose. Those with an HbA1c ≥ 9.5% showed greater reduction in HbA1c (10.8% to 9.3% [94.8 to 78.3 mmol/mol]) than those with an HbA1c<9.5% (8.6 to 8.1% [70.6 to 65.1 mmol/mol]), P<0.001. Those with HbA1c<9.5% had a greater mean weight reduction (104.0 to 100.3 kg v 104.3 to 102.5 kg, P<0.001), which was associated with greater reduction in insulin dose (102 to 83 U/day v 91 to 84 U/day, P<0.001). Reductions in all concomitant medications occurred. Conclusion: Within our routine practice, dapagliflozin was associated with a greater reduction in HbA1c in patients with worse glycaemic control.