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FDA approves empagliflozin/linagliptin tablets for improving glycemic control

Wednesday, February 11 2015 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration approved the combination tablet empagliflozin/linagliptin for the treatment of type 2 diabetes in adults, as an adjunct to diet and exercise.

Empagliflozin/linagliptin, which was developed by Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. and will be marketed as Glyxambi, is a once-daily tablet containing 10 mg or 25 mg of empagliflozin, a sodium glucose cotransporter-2 (SGLT2) inhibitor, and 5 mg of linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor. It is the first SGLT2/DPP-4 inhibitors combination medication in the United States.

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

The new tablet is not indicated for type 1 diabetes or for those with pancreatitis. It also cannot be used in people with advanced chronic kidney disease, because empagliflozin is contraindicated in such patients.

The FDA approval was based on a Phase III clinical trial comparing the combination of empagliflozin/linagliptin at both the 10 mg/5 mg and 25 mg/5 mg doses to the individual doses of both drugs. The study included 686 adults with diabetes and hemoglobin A1C levels between 7.0% and 10.5% despite taking high-dose metformin (mean dose: 1,889 mg/day).

At 24 weeks, mean A1C levels were 6.9% for the empagliflozin 10 mg/linagliptin 5 mg group and 6.7% for the empagliflozin 25 mg/linagliptin 5 mg group compared with 7.3% and 7.4% with empagliflozin 10 mg and 25 mg, respectively, and 7.3% with linagliptin 5 mg.

The proportions of patients who achieved A1C values <7% were 58% with the empagliflozin 10 mg/linagliptin 5 mg group and 62% with the empagliflozin 25 mg/linagliptin 5 mg group compared with 28%, 33%, and 36% for empagliflozin 10 mg, empagliflozin 25 mg, and linagliptin 5 mg, respectively. Patients who took the combination also lost slightly more than 3% of their body weight.

The safety profile of the combination pill was no different than the expected safety profile of each drug by itself. At 52 weeks, urinary tract infections (UTIs) occurred in 12.5% of patients in the empagliflozin 10 mg/linagliptin 5 mg group and 11.4% in the empagliflozin 25 mg/linagliptin 5 mg group, but no patients discontinued because of a UTI. Other common adverse events included nasopharyngitis and upper-respiratory-tract infection. The risk of hypoglycemia was low.

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