AstraZeneca announced that 86 abstracts reporting results of the company’s research and development in diabetes have been accepted for presentation at the 75th scientific sessions of the American Diabetes Association (ADA) in Boston, starting from June 5-9, 2015.
The abstracts include clinical data evaluating Forxiga (dapagliflozin, marketed in the U.S. as Farxiga, Bydureon (exenatide extended-release for injectable suspension), Byetta (exenatide) injection and Onglyza (saxagliptin), as well as the investigational combination of saxagliptin and dapagliflozin. Among the abstracts accepted are studies evaluating long-term durability; safety and efficacy; medication adherence; and benefits and treatment effects across diverse subpopulations segmented by ethnicity and risk factors such as kidney disease and cardiovascular (CV) disease.
Notable late-breaker abstracts include data from a phase III study comparing the efficacy and safety of dapagliflozin versus placebo as an add-on to saxagliptin and metformin in adults with type 2 diabetes who had inadequate glycaemic control, including an overview of the open-label lead-in period.
“The extensive scientific data at ADA underscore our research goals to better understand the long-term effects of newer classes of medicines across different patient populations,” said Elisabeth Björk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development, AstraZeneca.
“These data further demonstrate the value of our current portfolio to help address the needs of a broad range of patients with type 2 diabetes.”
In addition to advancing clinical and scientific discussions, AstraZeneca is also presenting a number of observational and medical outcomes studies, including new real-world data from an observational, retrospective claims database study comparing the risk of hospitalisation for heart failure between DPP-4 inhibitors vs. sulfonylureas and comparing saxagliptin with sitagliptin.
Notable clinical and pre-clinical data being presented across key focus areas for AstraZeneca include study of baseline albuminuria level versus the efficacy of dapagliflozin in patients with type 2 diabetes, assessment of dapagliflozin effects on albuminuria reductions in hypertensive patients with diabetes, pharmacodynamic comparison of dapagliflozin in patients with type 1 or type 2 diabetes, an analysis of dapagliflozin on insulin resistance in type 2 diabetes, pre-clinical analysis of the effects of a GLP-1 receptor agonist/glucagon co-agonist (MEDI0382) on weight.
It also includes data assessing combination treatments and treatment approaches in select subgroups of patients, an analysis of triple therapy with dapagliflozin versus placebo when added-on to saxagliptin plus metformin, including an overview of the open-label lead-in period,
study determining influential factors affecting preferences for the treatment of diabetes, a study examining the addition of saxagliptin, compared to placebo, treatment with dapagliflozin and metformin in patients with type 2 diabetes with inadequate glycaemic control.
The clinical and pre-clinical data also comprises of a study examining the addition of dapagliflozin, compared to placebo, to treatment with saxagliptin and metformin in patients with type 2 diabetes with inadequate glycaemic control, retrospective study of once-weekly exenatide treatment and adherence in elderly patients compared to other GLP-1 receptor agonists, comparison of one-year adherence, costs and utilisation between insured patients with type 2 diabetes initiating liraglutide or once-weekly exenatide, dapagliflozin as a treatment option for African Americans and Hispanic Adult patients with type 2 diabetes, saxagliptin as a treatment option for Caucasian, African Americans, Asian, and Hispanic patients with type 2 diabetes.
It also includes pre-clinical assessment of interactions of low dose combinations of GLP-1 receptor and GIP on glucose control in mice, data assessing the long-term effect and durability of AstraZeneca diabetes treatments, effect on dapagliflozin on weight over the first year of treatment through the subsequent three years, study of long-term effects of once-weekly exenatide on weight gain and hypoglycaemia, compared to insulin glargine, effects of exenatide twice daily and once weekly on A1C in patients with type 2 diabetes and baseline A1C =10 per cent, analysis of the use of saxagliptin and cancer risk in the SAVOR trial, data assessing diabetes treatments and cardiovascular outcomes in patients at high CV risk, analysis of dapagliflozin on CV events in elderly patients with type 2 diabetes, SAVOR analysis on rates of CV risk and polyvascular disease in patients with type 2 diabetes, analysis of long-term efficacy of dapagliflozin treatment on patients with CV disease and type 2 diabetes, results of the SAVOR trial analysing CV outcomes in African Americans receiving treatment with saxagliptin, observational analysis comparison of the risk of hospitalisation for heart failure between DPP-4 inhibitors vs. sulfonylureas and with saxagliptin vs. sitagliptin.
Diabetes is estimated to affect 29.1 million people in the US and more than 387 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035. Type 2 diabetes accounts for approximately 90-95 per cent of all cases of diagnosed diabetes in the US. Type 2 diabetes is a chronic disease characterised by pathophysiologic defects leading to elevated glucose levels. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. It is estimated that more than half of people living with type 2 diabetes are not achieving recommended HbA1c goals based on guidelines established by professional societies and advocacy organisations for diabetes management.
AstraZeneca is pushing the boundaries of science to create life-changing medicines that aim to reduce the global burden and complications of diabetes. Driven to redefine outcomes for diabetes patients, the company's current portfolio consists of the three newest classes of non-insulin, anti-diabetic treatments that support individualised treatment approaches: SGLT-2 inhibitors, GLP-1 receptor agonists and DPP-4 inhibitors.