Dapagliflozin (DAPA), an SGLT2 inhibitor, increases urinary glucose excretion and reduces hyperglycaemia independently of insulin. Extended treatment results (wk 102-104) for 24-wk, randomised, double-blind, placebo (PBO)-controlled trials in patients with T2DM who received DAPA as monotherapy (MONO; NCT00528372), add-on to metformin (MET; NCT00528879), or add-on to insulin ± oral antidiabetic (INS; NCT00673231) are reported. DAPA 10 mg/d produced sustained reductions in HbA1c from baseline (Figure) and more patients achieved HbA1c <7% vs PBO (Table). Increases from baseline in urinary glucose:creatinine (g/g) endured at Wk 102; for example, change (95% CI) in the add-on to MET study was 31.8 (25.0, 38.5) for DAPA 10 mg vs -0.2 (-0.6, 0.2) for PBO. Reductions in body weight persisted (Table). Adverse events were generally balanced across groups and similar percentages of patients reported hypoglycaemic events for DAPA 10 mg and PBO (MONO, 5.3% vs 4.3%; MET, 5.8% vs 5.2%; INS, 61.9% vs 60.7%). Events suggestive of genital and urinary tract infection were greater with DAPA vs PBO in all studies; infections were mostly mild to moderate in severity and occurred more often in the first 24 wks. HbA1c and body weight reductions were sustained with long-term DAPA MONO or add-on therapy to MET or INS.

–