ASTRAZENECA PLC Head-to-head results of Farxiga vs. insulin or sulfonylurea in type-2 diabetes, with key data on the safety and efficacy of Farxiga in both type-1 and type-2 diabetes
Results of 10 randomised trials from the DURATION
clinical programme for Bydureon
New data on MEDI0382, a potential first-in-class
oxyntomodulin-like peptide for type-2 diabetes
AstraZeneca and MedImmune, its global biologics research and development arm, will present more than 50 abstracts from the Company's Cardiovascular, Renal & Metabolism (CVRM) therapy area at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany, 1-5 October 2018.
This latest research underscores AstraZeneca's expansive clinical trial programme and comprehensive approach to advancing clinical practice in the management of cardiovascular, renal and metabolic (CaReMe) diseases. Data to be presented from the Company's broad portfolio include Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) in type-2 diabetes (T2D), alone and in combination with other diabetes therapies. Highlights also include data on the potential of Farxiga in type-1 diabetes (T1D) and additional pre-clinical and clinical data for MEDI0382, a potential first-in-class oxyntomodulin-like peptide for type-2 diabetes and the latest candidate in the Company's CVRM pipeline.
Ludovic Helfgott, Vice President, Cardiovascular, Renal and Metabolism at AstraZeneca, said: 'Our key data at EASD will expand understanding around the persistent cardiovascular and renal risks in patients with type-2 diabetes, as well as the unmet need in type-1 diabetes, where we are at the forefront of advancing treatment for patients. We are constantly pursuing science to advance the management of cardiovascular, renal and metabolic diseases to improve patient outcomes.'
New data to highlight the potential of Farxiga in T2D and interconnectivity between CV and renal diseases
Highlights include several abstracts evaluating the effects of Farxiga alone and in combination in treating T2D, and in patients with CV (including heart failure) and renal risk factors. Research into CaReMe diseases includes a recent trial on CV outcomes and mortality in people with T2D and associated comorbidities (Poster #1177). The results will illustrate the importance of identifying novel protection strategies for various T2D-related comorbidities, including heart failure and chronic kidney disease, and may have implications for investigating risk in T2D patients.
A further presentation will include 52-week results of Farxiga as an add-on therapy to Onglyza (saxagliptin) in addition to metformin, compared with insulin in patients with or without sulfonylurea therapy.
For patients with T1D, insulin is the standard therapy with no oral treatment options approved to date. The latest sub-analysis (Poster #612) of pooled data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 Diabetes) clinical trial programme (DEPICT-1 and DEPICT-2) features an evaluation on the effect of Farxiga in T1D patients taking adjustable insulin treatment. The analysis will look at two composite endpoints, including those determining instances of weight gain, severe hypoglycaemia and diabetic ketoacidosis (DKA). Farxiga is currently not approved in T1D.
AstraZeneca will also present an analysis from the CVD-REAL study (Poster #635) which evaluated the efficacy and safety of SGLT2 inhibitors vs. other glucose-lowering medicines. This additional analysis will look at data across a larger number of countries and patients, with a longer duration of follow up than previously evaluated.
Comprehensive new analyses of the safety and efficacy of Bydureon
Results will also be presented from 10 randomised Phase III, 24-to-30-week clinical trials within the DURATION programme (Poster #737), which evaluated the safety and efficacy of glucagon-like peptide-1 (GLP-1) receptor agonist Bydureon, administered once-weekly either subcutaneously or with an autoinjector, in patients with T2D.
Advancing a potential first-in-class approach to T2D with MEDI0382
From the Company's promising CVRM pipeline, there will be an oral presentation of data from a Phase IIa trial on the observed effects of MEDI0382 on glucose control and weight loss in patients with T2D (Presentation #164). MEDI0382 is an oxyntomodulin-like peptide and potential new medicine designed to simultaneously activate the GLP-1 and glucagon (GLU) receptors, with the goal of achieving glucose control, reduced body weight and increased energy expenditure in patients with T2D.
Details of the key abstracts from AstraZeneca/MedImmune at EASD 2018:
Abstract title | Presentation details |
Farxiga | |
Effects of dapagliflozin on urine and plasma metabolome in patients with type 2 diabetes: preliminary results | Poster #653 |
Pooled data analysis of composite endpoints from the DEPICT-1 and DEPICT-2 studies using dapagliflozin compared to placebo added to adjustable insulin in type 1 diabetes | Poster #612 |
Pooled analysis of the duration of type 1 diabetes in dapagliflozin vs placebo on adjustable insulin therapy from DEPICT 1 and 2: effects on glycaemia, weight and insulin dosage | Poster #613 |
Dapagliflozin preserves renal function in patients with T2DM: a longitudinal meta-analysis of eGFR in clinical trials | Poster #617 |
Effect of dapagliflozin on renal and cardiac function in patients with type 2 diabetes and albuminuria - a randomized study | Poster #619 |
Efficacy of dapagliflozin plus saxagliptin vs insulin glargine at 52 weeks in patients with type 2 diabetes inadequately controlled by metformin with or without sulfonylurea | Poster #775 |
Effect of dapagliflozin (DAPA) on cardiovascular and renal risk factors in patients with type 2 diabetes treated with or without renin-angiotensin system inhibitors (RASi) | Poster #622 |
Durability of improved patient-reported outcomes in type 2 diabetes patients treated with dapagliflozin plus saxagliptin vs insulin glargine | Poster #830 |
New SGLT-2i versus bolus insulin users as add-on to stable basal insulin treatment in T2D and associated risks of cardiovascular disease and mortality: an observational stud | Presentation #113 |
Lower cardiovascular risk with SGLT-2 inhibitors vs other glucose-lowering drugs - real world data from Asia Pacific, North America, Europe and Middle East: the CVD-REAL study | Poster #635. |
DAPADream: improvement of time in range after SGLT2-add-on-medication in youth and young adults with T1D during unannounced meals under full closed loop CSII | Poster #640 |
Dapagliflozin plus saxagliptin add-on to metformin reduces liver fat and adipose tissue volume in patients with type 2 diabetes | Poster #647 |
Bydureon | |
DURATION-8 randomised controlled trial 104-week results: efficacy and safety of once-weekly exenatide (ExQW) plus once-daily dapagliflozin (DAPA) versus ExQW or DAPA alone | Presentation #37 |
Potential impact of differential drop-in of open-label diabetes medications in EXSCEL | Presentation #40 |
Cardiovascular safety and efficacy of exenatide once-weekly in patients with moderate renal dysfunction in the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) | Presentation #73 |
Effect of the exenatide plus dapagliflozin combination on fatty liver index and insulin resistance in type 2 diabetes mellitus patients: the DURATION-8 trial | Poster #721 |
Efficacy and safety with exenatide once weekly: clinical trial results from 10 randomised trials (the DURATION programme) | Poster #737 |
MEDI0382 | |
MEDI0382, a GLP-1/glucagon receptor dual agonist, reduces weight and improves metabolism via central and peripheral actions | Poster #605 |
MEDI0382, a glucagon-like peptide 1/glucagon receptor dual agonist, in patients with type 2 diabetes: a multiple-ascending-dose study | Poster #718 |
MEDI0382, a GLP-1/glucagon receptor dual agonist, improves NASH and reduces liver fibrosis in mice | Poster #1210 |
MEDI0382, a glucagon-like peptide 1/glucagon receptor dual agonist, significantly reduces hepatic fat content in subjects with type 2 diabetes mellitus | Poster #727 |
Effects of MEDI0382, a glucagon-like peptide 1/glucagon receptor dual agonist, on pancreatic and incretin hormones | Poster #778 |
MEDI0382, a dual GLP-1 glucagon receptor agonist, promotes rapid glucose control and significant weight loss in patients with type 2 diabetes | Presentation #164 |
Robust glucose control and weight loss after 6 weeks of treatment with MEDI0382, a balanced GLP-1/glucagon receptor dual agonist, in patients with type 2 diabetes | Poster #743 |
General diabetes | |
Quality of life in patients with type 2 diabetes initiating a second-line glucose-lowering therapy: the global DISCOVER study | Poster #344 |
Change over 12 months in HbA1c, fasting plasma glucose and weight among patients with type 2 diabetes in 37 countries: DISCOVER | Poster #294 |
Global patterns of cardiovascular risk factor control in patients with type 2 diabetes mellitus: insights from the global DISCOVER study | Poster #854 |
Second-line glucose-lowering therapies as chosen by cardiologists versus con-cardiologists: an analysis of the Diabetes Collaborative Registry | Poster #345 |
Eligibility varies across the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials among adults with type 2 diabetes: implications from the Diabetes Collaborative Registry | Poster #1151 |
Cardiovascular outcomes and mortality in type 2 diabetes with associated cardio-renal-metabolic comorbidities | Poster #1177 |
Early science | |
A novel human pluripotent stem cell (HPSC) derived alpha-cell model that behaves like primary cells in vitro and in vivo | Presentation #104 |
Pharmacological characterisation of an ultra-long acting once weekly Insulin-Fc fusion with continuous glucose monitoring | Poster #483 |
MEDI4166, an antibody-peptide fusion molecule: multiple-ascending-dose study in patients with type 2 diabetes mellitus | Presentation #166 |
A novel preclinical model to define the window between plasma glucose lowering versus water retention in the gut during SGLT1 inhibition | Poster #491 |
The dual PPARα/γ-agonist tesaglitazar robustly induces browning of white fat in vitro and in vivo | Presentation #200 |
Novel FGF family members may represent drivers of β-cell dedifferentiation in T2D | Presentation #190 |
Bottom-up islet engineering | Presentation #237 |
The full list of AstraZeneca/MedImmune scientific data can be accessed on the EASD website here. You can also follow us live during EASD 2018 on Twitter and LinkedIn.
NOTES TO EDITORS
About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)
Cardiovascular, renal and metabolism together form one of AstraZeneca's main therapy areas and are key growth drivers for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and potentially regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. 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 and follow us on Twitter @AstraZeneca.
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AstraZeneca plc published this content on 20 September 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 20 September 2018 06:12:27 UTC
