OBJECTIVE: In the EMPA-REG H2H-SU trial in patients with type 2 diabetes with inadequate glycemic control on metformin, empagliflozin 25 mg given for 104 weeks provided a sustained reduction in HbA1c , with a small yet statistically significant benefit versus glimepiride, sustained reductions in weight and blood pressure, and low risk of hypoglycemia. We report results at week 208 including a 104-week masked extension.

RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes and HbA1c 7%-10% were randomized to empagliflozin 25 mg or glimepiride 1-4 mg for 104 weeks as add-on to metformin. Patients who completed the randomized treatment period could participate in a 104-week extension in which they continued double-blind the treatment allocated at randomization.

RESULTS: Of 765 and 780 patients treated with empagliflozin and glimepiride, 576 and 549, respectively, entered the extension. At week 208, the adjusted mean difference in change from baseline in HbA1c with empagliflozin versus glimepiride was -0.18% (95% CI -0.33 to -0.03); p=0.0172. Rescue therapy was given to 23% of patients on empagliflozin and 34% on glimepiride (odds ratio: 0.56 [95% CI 0.45, 0.71]; p<0.0001). Confirmed hypoglycemic adverse events (plasma glucose ≤3.9 mmol/L and/or requiring assistance) occurred in 3% of patients on empagliflozin and 28% on glimepiride (odds ratio: 0.08 [95% CI 0.05, 0.13]; p<0.0001).

CONCLUSIONS: In patients with type 2 diabetes, empagliflozin 25 mg as add-on to metformin for 208 weeks reduced HbA1c with a significantly lower risk of hypoglycemia and a significantly smaller proportion of patients receiving rescue therapy compared with glimepiride. This article is protected by copyright. All rights reserved.