The results of a 78-week phase III clinical trial of the investigational agent Empagliflozin as add-on to basal Insulin in adults with type 2 diabetes ( T2D ), presented at the American Diabetes Association ( ADA ) 73rd Scientific Sessions, have showed that Empagliflozin 10 mg or 25 mg, plus Insulin, produced statistically significant reductions in HbA1c, compared with Insulin alone at the study's primary endpoint, week 18, as well as at week 78.
Empagliflozin is a member of the sodium glucose co-transporter-2 ( SGLT2 ) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with diabetes mellitus type 2. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
Results of the study with Empagliflozin as add-on to basal Insulin in people with type 2 diabetes included the following:
Placebo-adjusted reductions in HbA1c for Empagliflozin 10 mg and 25 mg by 0.6% and 0.7% ( p less than 0.001 ), respectively, at week 18, and by 0.5% and 0.6%, respectively, at week 78 ( p less than 0.001 ). The study included an 18-week fixed Insulin dose period, after which the dose was adjusted at investigator discretion.
At week 78, the placebo-adjusted change in required daily Insulin dose was decreased by 6.7 International Units ( IU ) and 6.0 IU for Empagliflozin 10 mg ( p=0.002 ) and 25 mg ( p=0.009 ), respectively.
Drug-related adverse events were reported by 39% and 44% of patients on Empagliflozin 10 mg and 25 mg, respectively, and by 31% of patients on placebo. Hypoglycemia was reported in 36% of patients on Empagliflozin 10 mg and 25 mg, and by 35% on placebo. Two patients on Empagliflozin 25 mg required assistance to treat the hypoglycemic event. Adverse events consistent with urinary tract infection were reported in 15%, 12% and 9% of patients on Empagliflozin 10 mg, 25 mg and placebo, respectively. Adverse events consistent with genital infection were reported in 8%, 5% and 2% of patients on Empagliflozin 10 mg, 25 mg and placebo, respectively. ( Xagena )
Source: Lilly, 2013