AACE: Empagliflozin: Another SGLT2-I on the Rise

Empagliflozin shows improvements in key diabetes parameters as well as weight reduction….

Empagliflozin, Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company’s sodium glucose cotransporter-2 inhibitor (SGLT2-I), works similarly to the newly FDA approved Invokana. SGLT2 inhibitors block glucose reuptake in the kidney and allow for excess glucose to be excreted in the urine.

Results from an open-label trial following up on a previous randomized trial studying empagliflozin, showed that whether used alone or as an add-on to metformin, empagliflozin reductions in HbA1c levels, FPG levels, and body weight were observed when given to adults with type 2 diabetes.

In the open-label study, 659 patients who previously participated in one of the two 12-week, blinded, dose-finding empagliflozin trials, were treated for an additional 78 weeks with open-label empagliflozin 10mg or 25mg (monotherapy or add-on to metformin), metformin alone, or sitagliptin as add-on to metformin.

Results from the 90 weeks showed empagliflozin 10mg alone demonstrated a decrease in A1C levels of 0.34%, a decrease in FPG of 30.4mg/dL, and a decrease in body weight of 2.24 kg. Empagliflozin 25mg alone resulted in a decrease in A1C levels of 0.47%, a decrease in FPG of 27.8 mg/dL, and a decrease in body weight of 2.61 kg. Metformin alone showed a reduction in A1C, FPG, and body weight of 0.56%, 26mg/dL, and 1.28 kg, respectively. Metformin plus empagliflozin showed reductions versus sitagliptin on A1C levels (-0.34 EMPA 10mg; -0.63 EMPA 25mg; and -0.40 sitagliptin); FPG levels (-21.3 EMPA 10mg; -31.8 EMPA 25mg; and -15.6 sitagliptin); and body weight (-3.14 EMPA 10mg; -4.03 EMPA 25mg; and -0.41 sitagliptin).

Although the results are promising, speculation is being made regarding long-term consequences when using this drug. Slightly more genital infections have been reported related to the use of empagliflozin when compared to metformin or sitagliptin. Also, due to empagliflozin’s renal elimination, researchers did look closely at glomerular filtration rates. To date, they have not discovered any marked decreases in GFR with the use of empagliflozin as monotherapy or add-on to metformin. Larger and longer duration studies are needed, but for now, an additional drug to treat this growing epidemic of diabetes is definitely a step in the right direction.

Ferrannini E, et al ""Empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor for 90 weeks provides sustained glycemic control and weight loss in patients with type 2 diabetes" AACE 2013; Abstract 1102