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Empagliflozin added to Metformin or Metformin plus sulfonylurea in adults with type 2 diabetes: significant reduction in blood glucose


The results of two phase III 24-week clinical trials of the investigational agent Empagliflozin added to Metformin with and without the addition of sulfonylurea, in people with type 2 diabetes ( T2D ) were presented at the American Diabetes Association ( ADA ) 73rd Scientific Sessions.
The results showed statistically significant improvements in blood glucose as measured by reductions in HbA1c after 24 weeks among people who received Empagliflozin.

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 type 2 diabetes. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.

The study also demonstrated statistically significant reductions in key secondary endpoints, including mean daily glucose concentration and body weight. Overall, adverse events were reported in a similar percentage of patients treated with Empagliflozin 10 mg, Empagliflozin 25 mg and placebo.

Study with Empagliflozin as add-on to Metformin

In this 24-week randomized, double-blind, placebo-controlled trial, the addition of Empagliflozin to a background of Metformin showed a placebo-adjusted reduction in HbA1c of 0.57% and 0.64% ( p less than 0.001 ) for Empagliflozin 10 mg ( n=217 ) and 25 mg ( n=213 ), respectively, compared with placebo ( n=207 ).
The study also showed a statistically significant placebo-adjusted reduction at 24 weeks in mean daily glucose concentration of 8 mg/dL with Empagliflozin 10 mg ( p=0.006 ) and 12 mg/dL with Empagliflozin 25 mg ( p less than 0.001 ). Body weight also significantly decreased by 3.6 lbs and 4.4 lbs ( p less than 0.001 ) with the addition of Empagliflozin 10 mg and 25 mg, respectively, compared with Metformin.

Drug-related adverse events were reported by 16.1%, 12.6%, and 12.1% of patients on Empagliflozin 10 mg, Empagliflozin 25 mg, and placebo, respectively. Confirmed hypoglycemia was reported in 1.8% of patients on Empagliflozin 10 mg, 1.4% on Empagliflozin 25 mg and 0.5% on placebo, none of which required assistance.
Adverse events consistent with urinary tract infection were reported in 5.1% of patients on Empagliflozin 10 mg, 5.6% on Empagliflozin 25 mg and 4.9% on placebo.
Adverse events consistent with genital infection were reported in 3.7% of patients on Empagliflozin 10 mg, 4.7% on Empagliflozin 25 mg and 0.0% on placebo.

Study with Empagliflozin as add-on to Metformin and sulfonylurea

In this 24-week randomized, double-blind, placebo-controlled trial, the addition of Empagliflozin to a background of Metformin plus sulfonylurea therapy showed a placebo-adjusted reduction in HbA1c of 0.64% and 0.59% ( p less than 0.001 ) for Empagliflozin 10 mg ( n=225 ) and 25 mg ( n=216 ), respectively, compared with placebo ( n=225 ).
The study also showed statistically significant placebo-adjusted reductions at 24 weeks in mean daily glucose concentration of 10.02 mg/dL and 13.06 mg/dL ( p less than 0.001 ) with Empagliflozin 10 mg and 25 mg., respectively.
Reductions in body weight were significantly greater with the addition of Empagliflozin to Metformin plus sulfonylurea ( change in body weight of 3.88 lbs, 10 mg; and 4.39 lbs, 25mg; p less than 0.001 ).

Drug-related adverse events were reported by 24.1%, 19.8% and 15.1% of patients on Empagliflozin 10 mg, Empagliflozin 25 mg, and placebo, respectively. Confirmed hypoglycemia was reported in 16.1% of patients on Empagliflozin 10 mg, 11.5% on Empagliflozin 25 mg and 8.4% on placebo, none of which required assistance.
Adverse events consistent with urinary tract infection were reported in 10.3% of patients on Empagliflozin 10 mg, 8.3% on Empagliflozin 25 mg and 8.0% on placebo.
Adverse events consistent with genital infection were reported in 2.7% of patients on Empagliflozin 10 mg, 2.3% on Empagliflozin 25 mg and 0.9% on placebo. ( Xagena )

Source: Lilly, 2013

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