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2014-05-13

AstraZeneca: AstraZeneca announces positive results from Phase III study of saxagliptin/dapagliflozin combination

Study showed patients inadequately controlled on metformin achieved
statistically significant reduction of HbA1c with the combination of
saxagliptin and dapagliflozin versus either agent alone

Overall rates of adverse events similar between the three treatment
groups, and most were reported as mild or moderate in intensity.
Improvements in glycaemic control achieved without increased risk of
hypoglycaemia with more patients reaching goal HbA1c levels of less
than 7% and were associated with body weight reduction

AstraZeneca will commence a Phase III trial for dapagliflozin in
patients with Type 1 diabetes in 2014

AstraZeneca today announced results from a Phase III study 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.

Results from the combination study found that patients treated with
saxagliptin/dapagliflozin plus metformin achieved significantly
greater reductions in HbA1c versus either agent alone plus metformin
at 24 weeks, with an adjusted mean change from baseline HbA1c of
-1.47% in the saxagliptin/dapagliflozin combination group compared to
-0.88% in the saxagliptin group and -1.20% in the dapagliflozin
group. More patients in the saxagliptin/dapagliflozin combination
group (41%) achieved goal HbA1c levels of less than 7% compared to
patients in the saxagliptin (18%) and dapagliflozin (22%) groups.[1]
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The saxagliptin/dapagliflozin combination group achieved a
significantly greater adjusted mean reduction from baseline in
two-hour postprandial glucose (PPG) versus the saxagliptin group, but
not the dapagliflozin group. The adjusted mean reduction in fasting
plasma glucose (FPG) was greater in the saxagliptin/dapagliflozin
combination group (-38 mg/dL) than the saxagliptin group (-14 mg/dL),
but similar to the dapagliflozin group (-32 mg/dL). In this study,
overall rates of adverse events, including hypoglycaemia, were
similar between the three treatment groups, and most were reported as
mild or moderate in intensity.

"Diabetes is a progressive disease in which nearly half of patients do
not achieve their HbA1c goals. Despite the standard sequential use of
existing therapies, there is a need for new and earlier therapeutic
approaches that provide more robust HbA1c lowering," said lead
investigator Julio Rosenstock, MD, director of the Dallas Diabetes
and Endocrine Center at Medical City and clinical professor of
medicine at the University of Texas Southwestern Medical School,
Dallas, Texas. "What we've observed in this trial is when the two
independent mechanisms of action of saxagliptin and dapagliflozin are
used in combination, significant reductions in HbA1c associated with
weight loss are achieved in patients not adequately treated with
metformin alone, and more patients reached the HbA1c target goal
without increased risk of hypoglycaemcia while maintaining a similar
safety profile to the individual monotherapies."

"The results for the combination of saxagliptin and dapagliflozin
demonstrate our continued commitment to meeting the needs of patients
with type 2 diabetes by working to understand how these two medicines
with independent mechanisms of action may be used together to help
more patients achieve their treatment goals," said Briggs Morrison,
Executive Vice President, Global Medicines Development & Chief
Medical Officer, AstraZeneca.

This 24-week, Phase III, multi-center, randomised, double-blind,
active-controlled, parallel-group trial was designed to evaluate the
efficacy and safety of the combination of saxagliptin/dapagliflozin
as dual add-on therapy in adult patients with type 2 diabetes with
inadequate glycaemic control on metformin. The primary endpoint was
mean change in HbA1c from baseline to week 24. Secondary endpoints
included mean change from baseline in two-hour PPG during a liquid
meal test, FPG, body weight at week 24 in the
saxagliptin/dapagliflozin combination group versus the saxagliptin
group, and the proportion of patients who achieved glycaemic response
(defined as HbA1c < 7%).1

The study included 534 adult patients with type 2 diabetes (aged ≥ 18
years) with inadequate glycaemic control (HbA1c ≥ 8% and ≤ 12%) who
were receiving metformin extended-release (≥ 1,500 mg per day).
Patients were randomised 1:1:1 to receive the combination of
saxagliptin 5 mg and dapagliflozin 10 mg added to metformin,
saxagliptin and metformin added to placebo, or dapagliflozin and
metformin added to placebo, for 24 weeks.1

Future Development of AstraZeneca Oral Anti-Diabetic Franchise

Type 1 diabetes patients are dependent on lifelong insulin injections
which present a constant risk for hypoglycaemic events and long term
weight gain. AstraZeneca will commence a Phase III trial for
dapagliflozin in patients with Type 1 diabetes in 2014.

ENDS

NOTES TO EDITORS

About DPP4 inhibitors and SGLT2 inhibitors

Saxagliptin (marketed as Onglyza®) belongs to the class of medicines
called DPP-4 inhibitors, which work by increasing the activity of the
incretin hormones, increasing the release of insulin when glucose
levels are elevated and reducing the levels of sugar produced by the
liver (glucagon).[2]
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Dapagliflozin (marketed as Farxiga™ in the U.S. and Forxiga® outside
the U.S.) is part of a newer class of medicines called sodium-glucose
cotransporter 2 (SGLT2) inhibitors, which remove glucose via the
kidneys.

About Type 2 Diabetes

Diabetes is estimated to affect 25.8 million people in the U.S. and
more than 382 million people worldwide. The prevalence of diabetes is
projected to reach more than 592 million people worldwide by 2035.[3]
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Type 2 diabetes accounts for approximately 90-95 percent of all cases
of diagnosed diabetes in adults.[4]
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Type 2 diabetes is a chronic disease[5]
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characterised by pathophysiologic defects leading to elevated glucose
levels.[6]
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Over time, this sustained hyperglycaemia contributes to further
progression of the disease.[7]
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Significant unmet needs still exist, as many patients remain
inadequately controlled on their current glucose-lowering regimen.[8]
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About AstraZeneca

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

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)

Vanessa Rhodes +44 20 7604 8037 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 (UK/Global)

Michele Meixell +1 302 885 2677 (US)

Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries

Karl Hård +44 20 7604 8123  mob: +44 7789 654364

Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882

Anthony Brown +44 20 7604 8067 mob: +44 7585 404943

Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

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[1]
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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]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref2)
Bristol-Myers Squibb Company and AstraZeneca Pharmaceuticals LP. July
2009. Onglyza (saxagliptin) tablets: Highlights of Prescribing
Information. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf.
Accessed May 1, 2014.

[3]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref3)
International Diabetes Federation. IDF Diabetes Atlas, 6th edn.,
2013. Available at: http://www.idf.org/diabetesatlas. Accessed May 1,
2014.

[4]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref4)
Centers for Disease Control and Prevention. National Diabetes
Factsheet 2011. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed May 1,
2014.

[5]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref5)
World Health Organization. Media Centre - Diabetes. 2011. Available
at: http://www.who.int/mediacentre/factsheets/fs312/en/. Accessed May
1, 2014.

[6]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref6)
Kahn SE. The relative contributions of insulin resistance and
beta-cell dysfunction to the pathophysiology of type 2 diabetes.
Diabetologia. 2003;46:3-19.

[7]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref7)
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.

[8]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref8)
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.

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