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

Glyxambi is the first treatment to combine a sodium-glucose co-transporter 2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor in a once-daily tablet. Empagliflozin works by removing glucose through the urine by blocking blood glucose reabsorption in the kidney. Linagliptin works by increasing hormones that stimulate the pancreas to produce more insulin and stimulate the liver to decrease glucose production.

The FDA approval was based on a Phase 3 clinical trial (n=686) that studied the efficacy and safety of Glyxambi vs. individual empagliflozin or linagliptin in adults with type 2 diabetes who were also taking high-dose metformin. Adults with type 2 diabetes and HbA1c between 7.0 and 10.5% were examined for the change from baseline in HbA1c at 24 weeks.

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Treatment with Glyxambi resulted in statistically significant reductions in HbA1c vs. empagliflozin and linagliptin alone at 24 weeks. Patients with a baseline HbA1c of 8% achieved a mean HbA1c of 6.9 and 6.7% with Glyxambi 10mg/5mg and 25mg/5mg, respectively, compared with a mean HbA1c of 7.3 and 7.4% for empagliflozin 10mg and 25mg, respectively, and 7.3% for linagliptin 5mg.

Also, the percent of patients achieving an HbA1c <7% with Glyxambi 10mg/5mg or 25mg/5mg was 58% and 62%, respectively, vs. 28%, 33%, and 36% for empagliflozin 10mg, empagliflozin 25mg and linagliptin 5mg, respectively.

Glyxambi will be available in 10mg/5mg and 25mg/5mg strength tablets in 30-, 90-, and 1000-count bottles.

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