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DURATION-8 trial met primary and secondary endpoints, significantly reducing blood sugar (HbA1c), weight and systolic blood pressure versus either medicine alone
The first Phase III trial to assess GLP-1RA/SGLT-2i combination therapy
Positive results from the Phase III DURATION-8 trial demonstrated that BYDUREON (exenatide extended-release) for injectable suspension 2 mg once-weekly in combination with FARXIGA (dapagliflozin) 10 mg once-daily significantly reduced blood sugar as measured by HbA1c, versus the individual medicines alone in patients with type 2 diabetes inadequately controlled on metformin.1
This was the first clinical trial to combine these two different anti-diabetes medicines, a GLP-1 receptor agonist and an SGLT-2 inhibitor, as an addition to standard-of-care therapy to evaluate potential benefits for patients with type 2 diabetes with inadequate glycemic control. The results were presented today at the 52nd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany, and simultaneously published in The Lancet Diabetes & Endocrinology.1
The trial achieved its primary endpoint with the combination of exenatide once-weekly and dapagliflozin significantly reducing HbA1c from baseline compared with exenatide once-weekly or dapagliflozin alone (-2.0% versus -1.6% and -1.4% respectively, both P<0.01), at 28 weeks.1
Serge A. Jabbour, MD, FACP, FACE, Professor of Medicine, Director of the Division of Endocrinology and Director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, said: “Because of the progressive nature of type 2 diabetes, patients often require multiple anti-diabetic medicines to achieve and maintain glycemic control. The results of DURATION-8 show that combining medicines that work in different ways can significantly reduce HbA1c, as well as weight and systolic blood pressure.”
Elisabeth Bjrk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: “With DURATION-8, AstraZeneca is the first company to highlight the results of combining a GLP-1 receptor agonist and SGLT-2 inhibitor as a potential treatment alternative to existing non-insulin therapies for patients with severe, uncontrolled type 2 diabetes. Further, it reinforces our commitment to pushing the boundaries of science in the treatment of a disease that affects an estimated 415 million adults worldwide.”2
Secondary endpoints for the trial included changes in body weight and systolic blood pressure. Patients receiving the combination of exenatide once-weekly and dapagliflozin versus either exenatide once-weekly or dapagliflozin alone experienced:
This combination of products is not FDA approved, and neither product is approved for weight loss or the treatment of hypertension.
The combination of exenatide once-weekly and dapagliflozin exhibited similar rates of adverse events and serious adverse events to the individual medicine treatment groups. The most common adverse events (≥5% of patients in any group) were diarrhea, injection-site nodule, nausea and urinary tract infection.1
Indication and Important Limitations of Use for BYDUREON® (exenatide extended-release) for injectable suspension
BYDUREON is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF THYROID C-CELL TUMORS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
Most common (≥5%) and occurring more frequently than comparator in clinical trials: nausea (16.9%), diarrhea (12.7%), headache (8.0%), vomiting (6.8%), constipation (5.9%), injection-site pruritus (5.9%), injection-site nodule (5.3%), and dyspepsia (5.1%)
DRUG INTERACTIONS
PREGNANT AND NURSING WOMEN
Please click here for Full Prescribing Information and click here for Medication Guide for BYDUREON 2 mg, including Boxed WARNING regarding risk of thyroid C-cell tumors.
Indication and Limitations of Use for FARXIGA® (dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
FARXIGA is not indicated for weight loss or the treatment of hypertension.
10 mg is not the recommended starting dose for FARXIGA.
Important Safety Information for FARXIGA® (dapagliflozin)
Contraindications
Warnings and Precautions
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo respectively were female genital mycotic infections (8.4% vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Specific Populations
Please click here for US Full Prescribing Information and Medication Guide for FARXIGA.
NOTES TO EDITORS
About DURATION-8
DURATION-8 was a Phase III, randomized, multi-center, double-blind, active-controlled trial which evaluated the safety and efficacy of simultaneous administration of exenatide once-weekly and dapagliflozin once-daily compared to treatment with the individual medicines in adult patients with type 2 diabetes who were inadequately controlled on metformin.1
The trial was conducted over a 28-week treatment period, with an extension to two years, and enrolled approximately 700 patients in six countries. Eligible participants included adult patients with type 2 diabetes who had uncontrolled HbA1c (a protein within red blood cells that when bound with glucose is measurable to determine average blood sugar levels during a specific period) levels at baseline ranging from 8.0% to 12.0%. The primary endpoint was change in HbA1c from baseline to week 28. Secondary endpoints included changes in body weight, systolic blood pressure, fasting plasma glucose, two hour postprandial glucose and the proportion of patients achieving HbA1c <7.0% over the 28-week treatment period.1
About AstraZeneca in Diabetes
AstraZeneca is pushing the boundaries of science with the goal of developing life-changing medicines that aim to reduce the global burden and complications of diabetes. As a core therapy area for the company, we are focusing our research and development efforts on diverse populations and patients with significant co-morbidities, such as cardiovascular disease, obesity, non-alcoholic steatohepatitis (NASH), and chronic kidney disease.
Our commitment to diabetes is exemplified by the depth and breadth of our global clinical research program. This commitment is advancing understanding of the treatment effects of our diabetes medicines in broad patient populations, as well as exploring combination product approaches to help more patients achieve treatment success earlier in their disease progression. Our ambition is to reduce the long-term impact of diabetes.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Respiratory and Autoimmunity, Cardiovascular and Metabolic Diseases, and Oncology. The company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca-us.com
References
View source version on businesswire.com: http://www.businesswire.com/news/home/20160916005339/en/
AstraZenecaMichele Meixell, +1 302-885-2677orAbigail Bozarth, +1 302-885-2677
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