Wednesday, 11 June 2014
43 abstracts on approved products and an investigational compound accepted for presentation
First data from Phase III trial of saxagliptin/dapagliflozin combination presented as a late-breaker
First six-year, open-extension to the DURATION-1 trial examining the efficacy and tolerability of exenatide will be presented
AstraZeneca today announced that 43 abstracts reporting results of the company’s research and development in diabetes have been accepted for presentation at the 74th Scientific Sessions® of the American Diabetes Association (ADA) in San Francisco, 13-17 June 2014. Clinical data from studies evaluating multiple approved products, including Forxiga® (dapagliflozin, marketed in the US as Farxiga™), Bydureon® (exenatide extended-release for injectable suspension) and Onglyza® (saxagliptin), as well as the investigational combination of saxagliptin and dapagliflozin, demonstrate AstraZeneca’s continued commitment to addressing unmet medical needs across a wide spectrum of type 2 diabetes patients in different stages of the disease.
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “The robust scientific data that will be presented at ADA further strengthen our broad innovative portfolio that spans the entire spectrum of non-insulin anti-diabetic treatments. Our continued focus on advancing scientific knowledge reinforces our long-term commitment to diabetes, a core strategic area for us and an important platform for returning AstraZeneca to growth.”
“Diabetes is a progressive and complex disease which demands combination approaches to further improve patient care,” said Briggs Morrison, MD, Executive Vice President, Global Medicines Development & Chief Medical Officer, AstraZeneca. “Our data accepted for presentation at this year’s ADA, including trials evaluating our medicines in patients with significant comorbidities and in combination with other anti-diabetic agents, reflect AstraZeneca’s efforts to provide these treatment options that address the needs of patients at different stages of the disease.”
Notable data on an AstraZeneca investigational compound at ADA include:
- A late-breaker of the first presentation of Phase III data evaluating the investigational combination of saxagliptin/dapagliflozin as a dual add-on therapy in adult patients with type 2 diabetes who were inadequately controlled on metformin, the top-line results of which were announced in May. Results being presented at ADA, and published in the abstract available in Diabetes, include secondary outcome measures on body weight and efficacy. (#127-LB, Sunday, 15 June, 12:00 PM PDT)1
Notable data on approved AstraZeneca products at ADA include:
- An analysis from nine double-blind, placebo-controlled trials evaluating the safety of dapagliflozin in elderly patients (#269-OR, Monday, 16 June, 9:30 AM PDT)2
- An analysis from three randomised controlled trials examining the effect of exenatide extended-release for injectable suspension on daily blood glucose variability compared with basal insulin (#997-P, Saturday, 14 June, 11:30 AM PDT)3
- A sub-group analysis from the SAVOR trial examining the effect of saxagliptin on renal outcomes (#544-P, Saturday, 14 June, 11:30 AM PDT)4
- An analysis from two double-blind, placebo-controlled trials evaluating the effects of dapagliflozin on systolic blood pressure (#1033-P, Sunday, 15 June, 12:00 PM PDT)5
- A sub-group analysis from the SAVOR trial examining the effect of saxagliptin in elderly patients from the study population (#1057-P, Sunday, 15 June, 12:00 PM PDT)6
- An open-ended extension to the DURATION-1 trial examining the efficacy and tolerability of exenatide once-weekly over six years (#964-P, Saturday, 14 June, 11:30 AM PDT)7
- An analysis from five placebo-controlled trials examining the effects of saxagliptin on β-cell function in patients with latent autoimmune diabetes (#152-OR, Sunday, 15 June, 8:45 AM PDT)8
The complete list of AstraZeneca data presentations can be accessed on the ADA website here.
NOTES FOR EDITORS
About Type 2 Diabetes
Diabetes is estimated to affect 25.8 million people in the US and more than 382 million people worldwide. The prevalence of diabetes is projected to reach more than 592 million people worldwide by 2035.9 Type 2 diabetes accounts for approximately 90-95 percent of all cases of diagnosed diabetes in adults.10 Type 2 diabetes is a chronic disease11 characterised by pathophysiologic defects leading to elevated glucose levels.12 Over time, this sustained hyperglycaemia contributes to further progression of the disease.13 Significant unmet needs still exist, as many adult patients remain inadequately controlled on their current glucose-lowering regimen.14
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
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1 Rosenstock, J., et al. “Dual Add-On Therapy in Poorly Controlled Type 2 Diabetes on Metformin: Randomized, Double-Blind Trial of Saxagliptin+Dapagliflozin vs Saxagliptin and Dapagliflozin Alone.” American Diabetes Association Scientific Sessions 2014. Abstract #127-LB.
2 Mansfield, T., et al. “Dapagliflozin is Safe and Well-tolerated in Older patients with T2DM.” American Diabetes Association Scientific Sessions 2014. Abstract #269-OR.
3 Vora, J., et al. “Daily Blood Glucose Variability With Exenatide Once-Weekly Vs Basal Insulin in 3 RCTs.” American Diabetes Association Scientific Sessions 2014. Abstract #997-P.
4 Mosenzon, O., et al. “Effect of Saxagliptin on Renal Outcomes.” American Diabetes Association Scientific Sessions 2014. Abstract #544-P.
5 Weber, M., et al. “Dapagliflozin Lowered Ambulatory Blood Pressure in Patients With T2DM and Hypertension Inadequately Controlled by a Renin-Angiotensin System Blocker With or Without Another Agent.” American Diabetes Association Scientific Sessions 2014. Abstract #1033-P.
6 Leiter, L., et al. “Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial.” American Diabetes Association Scientific Sessions 2014. Abstract #1057-P.
7 Henry, R., et al. “An open-ended extension to the DURATION-1 trial examining the efficacy and tolerability of exenatide once-weekly over six years.” American Diabetes Association Scientific Sessions 2014. Abstract #964-P.
8 Pozzilli P., et al. “Saxagliptin Increases β-Cell Function and Improves HOMA Index in Patients with Latent Autoimmune Diabetes in Adults.” American Diabetes Association Scientific Sessions 2014. Abstract #152-OR.
9 International Diabetes Federation. IDF Diabetes Atlas, 6th edn., 2013. Available at: http://www.idf.org/diabetesatlas. Accessed April 25, 2014.
10 Centers for Disease Control and Prevention. National Diabetes Factsheet 2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed April 25, 2014.
11 World Health Organization. Media Centre – Diabetes. 2011. Available at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed April 25, 2014.
12 Kahn SE. The relative contributions of insulin resistance and beta-cell dysfunction to the pathophysiology of type 2 diabetes. Diabetologia. 2003;46:3-19.
13 Kahn SE. Clinical review 135: The importance of β-cell failure in the development and progression of type 2 diabetes. J Clin Endocrinol Metab. 2001;86(9):4047-4058.
14 Cheung B, Lond, Edin et al. Diabetes Prevalence and Therapeutic Target Achievement in the United States, 1999-2006. American Journal of Medicine. 2009;122:443-453.