AstraZeneca Posts Positive Results For Exenatide In T2D Trial
U.K. pharma giant AstraZeneca reported positive results from the Phase 3 trial of exenatide once-weekly suspension for autoinjection for patients with Type 2 diabetes.
The 28 week, open label, randomized, Phase 3 study DURATION-NEO-1 examined a new investigational formulation of exenatide in 377 patients with T2D who were falling short of adequate HbA1c control with proper diet and other oral anti-diabetic drugs. The new drug formulation achieved the primary endpoint of non-inferiority to twice-daily exenatide (Byetta) injection. The once-weekly suspension exenatide also achieved greater reductions in blood glucose levels compared to Byetta at the 28 weeks milestone.
Carol H. Wysham, lead study investigator from the Department of Endocrinology, Rockwood Clinic in Spokane, Washington, said, “The results provide evidence of the tolerability and efficacy of this investigational formulation of once-weekly exenatide suspension delivered through a single-use autoinjector.”
The study findings also showed that exenatide once-weekly suspension for autoinjection was also non-inferior in reducing levels of fasting plasma glucose, as well as weight loss.
Diabetes afflicts approximately 382 million people around the world and is expected to reach over 592 million by the year 2035. Type 2 diabetes, characterized by elevated glucose levels, is responsible for around 90 to 95 percent of all cases of diabetes.
AZ has invested considerably in its diabetes business, undertaking two major partnership transactions focused on diabetes with Bristol-Myers Squibb and Mitsubishi Tanabe in the last two years. The company merged its diabetes treatments marketing team with BMS’ in January of 2013 and signed a 3-year research partnership with Mitsubishi Tanabe in April.
Elisabeth Björk, AZ Head of Cardiovascular & Metabolism, Global Medicines Development, said, “The results from DURATION-NEO-1 support our continued commitment to diabetes patients through developing this new formulation of exenatide once-weekly suspension for autoinjection and investigating a new delivery device.”
The company presented its findings at the 50th Annual Meeting of the European Association for the Study of Diabetes (EASD) held in Vienna, Austria.