The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has recommended the approval of Glyxambi ( Empagliflozin / Linagliptin ) for use in adults with type 2 diabetes mellitus.
Glyxambi is a single tablet combining Jardiance ( Empagliflozin ), a sodium glucose co-transporter-2 ( SGLT2 ) inhibitor, and Trajenta ( Linagliptin ), a dipeptidyl peptidase-4 ( DPP-4 ) inhibitor.

This recommendation is based on data from three phase III clinical trials evaluating the efficacy and safety of Glyxambi in patients with type 2 diabetes mellitus.

Following a run-in period, two 24 week trials with adult patients with type 2 diabetes mellitus on Metformin studied: Empagliflozin added to Linagliptin versus placebo added to Linagliptin; Linagliptin added to Empagliflozin versus placebo added to Empagliflozin.
The trials showed statistically significant reductions in blood sugar levels when Empagliflozin was added to patients on Linagliptin and Metformin, and when Linagliptin was added to patients on Empagliflozin and Metformin, compared to adding placebo.

An additional factorial design study, which also investigated Jardiance and Linagliptin combined added to Metformin, was conducted for 52 weeks. This trial showed that the combination of Empagliflozin and Linagliptin added to Metformin resulted in clinically and statistically significant reductions in blood sugar levels in comparison to patients treated with Empagliflozin or Linagliptin alone when added to Metformin.

The safety profile of the combination in these trials was comparable to the safety profiles of the monocomponents.

The CHMP positive opinion recommends Glyxambi, fixed dose combination of Empagliflozin and Linagliptin, for use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when Metformin and/or sulphonylurea and one of the monocomponents of Glyxambi do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of Empagliflozin and Linagliptin.

The safety profile of the combination in these trials was comparable to the safety profiles of the monocomponents. ( Xagena )

Source: Boehringer Ingelheim, 2016

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