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Glyxambi (Empagliflozin/Linagliptin) Wins FDA Nod for Treatment of Type-2 Diabetes in Adults

First therapy to combine SGLT2 inhibitor and DPP-4 inhibitor in once-daily tablet

The FDA has approved Glyxambi (empagliflozin/linagliptin, Boehringer Ingelheim/Eli Lilly) as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.

Glyxambi is not recommended for the treatment of patients with type-1 diabetes or diabetic ketoacidosis. It has not been studied in patients with a history of pancreatitis, and it is not known whether the drug increases the risk of developing pancreatitis in these patients.

Glyxambi is the only diabetes treatment in the U.S. to combine the dual mechanisms of action of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet taken in the morning. Glyxambi combines 10 mg or 25 mg of empagliflozin with 5 mg of linagliptin.

SGLT2 inhibitors remove glucose through the urine by blocking blood glucose re-absorption in the kidney. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to produce less glucose.

The FDA’s approval was based on data from a phase III trial that evaluated the efficacy and safety of empagliflozin combined with linagliptin (10/5 mg and 25/5 mg) compared with that of the individual components of empagliflozin (10 mg or 25 mg) or linagliptin (5 mg) in adults with T2D who were also receiving high-dose metformin (mean dose: 1,889 mg daily). The study, which included 686 adults with T2D and hemoglobin A1C (HbA1C; a measure of the average blood glucose level during the past 2 to 3 three months) between 7.0% and 10.5%, examined the change from baseline in A1C at 24 weeks.

As an add-on to metformin, empagliflozin/linagliptin showed statistically significant reductions in HbA1C compared with empagliflozin or linagliptin alone at 24 weeks. Starting from a mean baseline of approximately 8.0%, the subjects achieved a mean HbA1C of 6.9% and 6.7% with empagliflozin/linagliptin 10/5 mg and 25/5 mg, respectively, compared with a mean of 7.3% and 7.4% for empagliflozin 10 mg and 25 mg, respectively, and 7.3% for linagliptin 5 mg.

The proportion of patients achieving an HbA1C of less than 7% percent with empagliflozin/linagliptin 10/5 mg or 25/5 mg was 58% and 62%, respectively, compared with 28%, 33%, and 36% for empagliflozin 10 mg, empagliflozin 25 mg, and linagliptin 5 mg, respectively.

Although not approved for reducing weight, empagliflozin/linagliptin provided significant weight loss at 24 weeks compared with linagliptin alone.

Through 52 weeks of treatment, the overall incidence of hypoglycemia was 2.2% and 3.6% for empagliflozin/linagliptin 10/5 mg and 25/5 mg, respectively, and no cases of severe hypoglycemia were reported in the trial. A lower dose of an insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia when used in combination with empagliflozin/linagliptin.

The most common adverse events (AEs) associated with empagliflozin/linagliptin included urinary tract infection, nasopharyngitis, and upper respiratory tract infection. Serious AEs can occur in patients treated with empagliflozin/linagliptin, including pancreatitis, dehydration, vaginal yeast infection, and yeast infection of the penis.

Source: Eli Lilly, February 2, 2015.

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