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FDA announces approval of new type 2 diabetes treatment, Glyxambi

On February 2, the US Food and Drug Administration announced the approval of Glyxambi (empagliflozin and linagliptin combination) tablets, a new treatment to be used as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes1. Glyxambi should not be administered for type 1 diabetes.

Glyxambi is a combination of a sodium glucose co-transporter-2 (SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor to be taken daily in the morning. The approval of Glyxambi is the first and only treatment to combine empagliflozin and linagliptin.

Approval was based on a phase III clinical trial that evaluated the safety and efficacy of Glyxambi, as an add-on to metformin, where 686 adult patients with type 2 diabetes and hemoglobin A1C (average blood sugar for the past two-three months) between 7.0 and 10.5 received Glyxambi. In comparison to empagliflozin and linagliptin taken alone patients experienced improvement with a decrease of A1C at 24 weeks.

Results showed when patients started with an A1C baseline of about 8% they achieved a mean A1C of 6.7% with Glyxambi 10/5 mg and 6.7% with 25/5 mg whereas empagliflozin 10 mg had a mean A1C of 7.3% and a mean of 7.4% with 5 mg and linagliptin 5 mg had a mean of 7.3%. Of the patients who took Glyxambi 10/5 mg, 58% of those reached an A1C of less than 7%.  Sixty-two percent who took 25/5 mg reached an AC1 of 7% or lower. In comparison, of the patients who took empagliflozin 10 mg, only 28% achieved an AC1 of 7% or lower, while only 33% of those taking emplagliflozin 25 mg  achieved 7% or lower, and only 36%  of those linagliptin 5 mg achieved 7% or lower.

The most common adverse events reported in the phase III clinical trial were urinary tract infection (occurring in 12.5% of patients who took 10/5 mg and 11.4% who took 22/5 mg), Nasopharyngitis (common cold) (occurring in 5.9% of patients who took 10/5 mg and 6.6% who took 25/5 mg), and upper respiratory tract infection (occurring 7% of patients who took either 10/5 mg and 25/5 mg). It is still unknown if Glyxambi causes an increase in the development of pancreatitis with patients who have a history of pancreatitis.

  1. U.S. FDA approves first-in-class Glyxambi® (empagliflozin/linagliptin) tablets for adults with type 2 diabetes. PR Newswire. February 2, 2015.