The FDA has approved combination empagliflozin/linagliptin (Glyxambi, Boehringer Ingelheim) as an adjunct to diet and exercise for treatment of adults with type 2 diabetes, according to a press release from the manufacturer.

Glyxambi, a once-daily oral tablet, is comprised of empagliflozin 10 mg or 25 mg and linagliptin 5 mg.

The new drug is currently the only prescription medication in the United States that combines a sodium-glucose co-transporter 2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor.

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“Today’s medical community recognizes the need to treat type 2 diabetes from multiple fronts to help patients improve glycemic control,” Paul Fonteyne, president and CEO, BIPI, said in the release.

“With Glyxambi, the dual inhibition of DPP-4 and SGLT2 — two proven targets in the treatment of type 2 diabetes — now provides U.S. physicians and patients with an option to simultaneously address multiple pathways to improve glycemic control.”

The FDA based its approval on a phase 3, randomized clinical trial evaluating the safety and efficacy of Glyxambi (empagliflozin 10 mg or 25 mg/linagliptin 5 mg) vs. its individual components (empagliflozin 10 mg or 25 mg or linagliptin 5 mg) in 686 adults with type 2 diabetes who were also taking high-dose metformin.

Results showed that Glyxambi, as an add-on to metformin, was associated with statistically significant reductions in HbA1c vs. empagliflozin and linagliptin at 24 weeks. Mean baseline HbA1c was about 8.0%, and patients taking Glyxambi achieved mean HbA1c levels of 6.9% with empagliflozin 10 mg/linagliptin 5 mg and 6.7% with empagliflozin 25 mg/linagliptin 5 mg, respectively.

In comparison, mean achieved HbA1c levels were 7.3% and 7.4% with empagliflozin 10 mg and 25 mg, respectively, and 7.3% with linagliptin 5 mg.

Further, 58% of patients achieved HbA1c levels lower than 7% with empagliflozin 10 mg/linagliptin 5 mg and 62% with empagliflozin 25 mg/linagliptin 5 mg vs. 28%, 33% and 36% for empagliflozin 10 mg, empagliflozin 25 mg and linagliptin 5 mg, respectively.

Additionally, while not approved for weight loss Glyxambi was linked to significant weight loss after 24 weeks, as compared with linagliptin alone.

After 52 weeks, data also showed that the incidence of hypoglycemia was 2.2% and 3.6% with empagliflozin 10 mg/linagliptin 5 mg and empagliflozin 25 mg/linagliptin 5 mg, respectively, and no cases of severe hypoglycemia were reported during the trial.

The most common adverse reactions were urinary tract infection, nasopharyngitis and upper respiratory tract infection.