FDA Approves New Combo Pill For Type 2 Diabetes

Glyxambi—a combination of the sodium glucose cotransporter-2 (SGLT2) inhibitor  empagliflozin and the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin—has been approved to treat type 2 diabetes in certain adults.

The drugs safety and efficacy was tested in a phase III clinical trial comparing the effects of Glyxambi (10/5 mg and 25/5 mg) against the individual components empagliflozin (10 mg or 25 mg) and linagliptin (5 mg) on 686 adults with type 2 diabetes already taking high-dose metformin.
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After 24 weeks, Glyxambi reduced A1C percentages significantly more than empagliflozin and linagliptin.

“The percentage of patients achieving an A1C less than 7% with GLYXAMBI 10/5 mg or 25/5 mg was 58% and 62%, respectively, compared with 2%, 33% and 36% for empagliflozin 10 mg, empagliflozin 25 mg and linagliptin 5 mg, respectively.”

The manufacturers’ advised that the drug should not be used by patients with end-stage renal disease, those receiving dialysis, or by patients with severe renal impairment.

The most common side effects recorded were urinary tract infection, nasopharyngitis, and upper respiratory tract infection.

-Michelle Canales

Reference:

Eli Lilly and Company. US FDA approves first-in-class Glyxambi (empagliflozin/linagliptin) tablets for adults with type 2 diabetes. February 2, 2015. https://investor.lilly.com/releasedetail.cfm?ReleaseID=894045. Accessed February 3, 2015.