The European Commission has granted marketing authorisation for Glyxambi (empagliflozin/linagliptin) for use in adults with type 2 diabetes (T2D).
Glyxambi, from the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance, is a single pill combining Jardiance (empagliflozin), a sodium glucose co-transporter-2 (SGLT2) inhibitor, and Trajenta (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Glyxambi is approved for use in adults with T2D to improve blood sugar control when metformin and/or sulphonylurea and one of the monocomponents of Glyxambi do not provide adequate blood sugar control, or when a patient is already being treated with the free combination of Jardiance and Trajenta.
The marketing authorisation is based on clinical data from three phase III clinical trials.
Following a run-in period, two 24-week trials with adult T2D patients on metformin studied: Jardiance added to Trajenta versus placebo added to Trajenta; Trajenta added to Jardiance versus placebo added to Jardiance; The trials showed statistically significant reductions in blood sugar levels when Jardiance was added to patients on Trajenta and metformin, and when Trajenta was added to patients on Jardiance and metformin, compared to adding placebo.
An additional factorial design study, which also investigated Jardiance and Trajenta combined, added to metformin, was conducted for 52 weeks. This trial showed that the combination of Jardiance and Trajenta added to metformin resulted in clinically and statistically significant reductions in blood sugar levels in comparison to patients treated with Jardiance or Trajenta alone when added to metformin.
The safety profile of the combination in these trials was comparable to the safety profiles of the monocomponents.
Glyxambi is a fixed dose combination of Jardiance and Trajenta. Glyxambi is approved for use in adults with T2D to improve blood sugar control when metformin and/or sulphonylurea and one of the monocomponents of Glyxambi® do not provide adequate blood sugar control, or when a patient is already being treated with the free combination of Jardiance and Trajenta.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centres on compounds representing several of the largest diabetes treatment classes. This alliance leverages the strengths of two of the world’s leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com (link is external).