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news.Elixir Pharmaceuticals, a developer of novel pharmaceuticals for the treatment of metabolic diseases, has announced positive results from a pivotal Phase III clinical study of the company's oral formulation of mitiglinide administered in combination with metformin for the treatment of patients with type 2 diabetes.
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The study achieved statistical and clinical significance in its primary efficacy endpoint. Patients receiving the combination of twice-daily mitiglinide and metformin experienced a statistically significant additional reduction in hemoglobin A1c (HbA1c) levels compared to patients receiving metformin alone.
In addition to meeting its efficacy endpoint, Elixir’s Phase III study demonstrated that the combination of metformin plus mitiglinide is a very safe therapy. The safety findings of this Phase III trial corroborated data from previous studies in more than 4,000 patients, demonstrating an excellent safety profile with no signals of serious adverse events related to mitiglinide.
The results from the Phase III study, along with data from earlier safety and efficacy studies, will support the submission of a new drug application to the FDA for Metgluna, Elixir’s lead product, in 2009. Metgluna is a fixed combination tablet of metformin plus mitiglinide offering convenient twice-daily dosing.
Paul Martha, chief medical officer of Elixir, said: “These positive results from our study provide additional clinical evidence supporting the benefits of Metgluna therapy in the treatment of type 2 diabetes. Metgluna, a one-tablet, fixed combination therapy taken twice daily could allow for a simple, effective and safe transition of patients on twice-daily metformin who need to attain better glycemic control.”