Elixir completes enrollment in Phase III diabetes drug trial
Elixir Pharmaceuticals has completed enrollment in its final pivotal phase III clinical study of mitiglinide for the treatment of patients with type 2 diabetes.
The study is expected to be completed during the third quarter of 2008, with data available shortly thereafter, according to the Cambridge, Mass-based company.
Elixir said that the results from the study will supplement the existing clinical database of more than 4,000 patients to form the basis of its anticipated new drug application submissions to the FDA in early 2009 for Glinsuna (mitiglinide) and a fixed combination product, Metgluna, combining metformin and Glinsuna.
The clinical study has enrolled more than 300 patients across 60 sites in the U.S. and is designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients whose blood sugar is not adequately controlled by metformin alone, Elixir said.
The study is expected to be completed during the third quarter of 2008, with data available shortly thereafter, according to the Cambridge, Mass-based company.
Elixir said that the results from the study will supplement the existing clinical database of more than 4,000 patients to form the basis of its anticipated new drug application submissions to the FDA in early 2009 for Glinsuna (mitiglinide) and a fixed combination product, Metgluna, combining metformin and Glinsuna.
The clinical study has enrolled more than 300 patients across 60 sites in the U.S. and is designed to evaluate the efficacy and safety of mitiglinide in combination with metformin in patients whose blood sugar is not adequately controlled by metformin alone, Elixir said.