|By PR Newswire||
|June 22, 2013 11:00 AM EDT||
CHICAGO, June 22, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed safety and efficacy results from three Phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) receptor agonist being studied as a once-weekly treatment for type 2 diabetes. In the trials, dulaglutide 1.5 mg was superior to placebo and to exenatide (AWARD-1), metformin (AWARD-3) and sitagliptin (AWARD-5) in reducing HbA1c (hemoglobin A1c) levels., In addition, a greater percentage of patients treated with dulaglutide 1.5 mg achieved an HbA1c goal of less than 7 percent versus all active comparators.
Findings from these three AWARD trials, which tested dulaglutide 1.5 mg and 0.75 mg against comparators, were presented today at the 73rd American Diabetes Association Scientific Sessions® in Chicago.
"Dulaglutide not only demonstrated superior glycemic control in these Phase III trials, it provided this control with once-weekly dosing, which may be attractive to both patients and healthcare professionals," said Guillermo Umpierrez, M.D., professor of medicine, division of endocrinology, metabolism, Emory University School of Medicine, and chief of diabetes and endocrinology, Grady Memorial Hospital. "It's encouraging news for this investigational GLP-1 receptor agonist."
In all three studies, patients taking dulaglutide 1.5 mg showed sustained weight loss for the duration of the trials. Patients taking dulaglutide 1.5 mg showed significant weight loss compared to patients taking sitagliptin (AWARD-5), and showed similar weight loss to patients taking comparators in AWARD-1 and AWARD-3.
Nausea was the most common adverse event reported across the studies for dulaglutide and was mostly mild to moderate and transient. No new safety signals were seen in any of the studies.
Dulaglutide showed low rates of hypoglycemia (blood glucose level less than or equal to 70 mg/dL) across these three AWARD trials. There were no cases of documented severe hypoglycemia in any of the trials.
"These results are a promising step forward in our effort to provide a new, once-weekly GLP-1 treatment option, giving patients another choice to help manage their diabetes," said Sherry Martin, M.D., senior medical director, Lilly Diabetes. "Dulaglutide represents an important component of our diabetes portfolio, as it could help us offer a broader range of options to patients across the diabetes spectrum."
Dulaglutide is among several diabetes molecules in Lilly's late-stage pipeline. The company has a number of potential new medicines in clinical development for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms. Lilly expects to submit dulaglutide to regulatory authorities in 2013 and to submit detailed data from two additional AWARD studies for presentation at scientific meetings in 2014.
About the AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) Studies
AWARD-1 was a randomized, 52-week, placebo-controlled comparison of the effects of dulaglutide and exenatide on glycemic control in patients with type 2 diabetes on metformin and pioglitazone. The primary objective of the study, conducted in 978 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, is superior to placebo in reducing HbA1c from baseline at 26 weeks.
AWARD-3 was a randomized, 52-week, double-blind comparison of the effects of dulaglutide and metformin on glycemic control in patients with early type 2 diabetes. The primary objective of the study, conducted in 807 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to metformin in reducing HbA1c from baseline at 26 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
AWARD-5 was a randomized, 104 week, double-blind, placebo-controlled comparison of the effects of dulaglutide and sitagliptin on glycemic control in patients with type 2 diabetes on metformin. The primary objective of the study, conducted in 1,098 patients, was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, is non-inferior to sitagliptin in reducing HbA1c from baseline at 52 weeks. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.
Approximately 25.8 million Americans and an estimated 371 million people worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when Lilly introduced the world's first commercial insulin. Today Lilly works to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions—from medicines to support programs and more—to make lives better. For more information, visit www.lillydiabetes.com.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers—through medicines and information—for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY
This press release contains forward-looking statements about dulaglutide that are based on Lilly's current expectations. Actual results could differ materially from these expectations. There are significant risks and uncertainties in the process of drug development and commercialization. There can be no guarantee that future study results and patient experience will be consistent with the study findings to date. There can also be no guarantee that dulaglutide will be submitted to regulatory authorities in 2013, that it will receive the necessary clinical and manufacturing regulatory approvals, or that it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Except as required by law, the company undertakes no duty to update forward-looking statements.
Refer to: Candace Johnson, +1-317-755-9143, [email protected]
Wysham C, Blevins T, Arakaki R, et al. Efficacy and safety of dulaglutide vs placebo and exenatide in type 2 diabetes (AWARD-1). Abstract 66-OR. Presented at: American Diabetes Association (ADA) 73rd Scientific Sessions; June 21-25, 2013; Chicago, IL.
Umpierrez GE, Manghi FP, Povedano ST, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide vs metformin in type 2 diabetes (AWARD-3). Abstract 69-OR. Presented at: American Diabetes Association (ADA) 73rd Scientific Sessions; June 21-25, 2013; Chicago, IL.
Nauck MA, Weinstock RS, Umpierrez GE, et al. Efficacy and safety of dulaglutide vs sitagliptin after 52 weeks in type 2 diabetes (AWARD-5). Abstract 71-OR. Presented at: American Diabetes Association (ADA) 73rd Scientific Sessions; June 21-25, 2013; Chicago, IL.
Weinstock RS, Umpierrez GE, Guerci B, Nauck MA, Boleyn KL, Skrivanek Z, Milicevic Z. Safety and efficacy of dulaglutide vs sitagliptin after 104 weeks in type 2 diabetes (AWARD-5). Abstract 1004-P. Presented at: American Diabetes Association (ADA) 73rd Scientific Sessions; June 21-25, 2013; Chicago, IL.
Centers for Disease Control. National Diabetes Fact Sheet-2011. Available at: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed on: February 22, 2012.
International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.
International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: February 22, 2012.
SOURCE Eli Lilly and Company
Your business relies on your applications and your employees to stay in business. Whether you develop apps or manage business critical apps that help fuel your business, what happens when users experience sluggish performance? You and all technical teams across the organization – application, network, operations, among others, as well as, those outside the organization, like ISPs and third-party providers – are called in to solve the problem.
Feb. 6, 2016 02:00 PM EST Reads: 671
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 6, 2016 01:30 PM EST Reads: 327
@DevOpsSummit taking place June 7-9, 2016 at Javits Center, New York City, and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
Feb. 6, 2016 01:15 PM EST Reads: 503
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
Feb. 6, 2016 01:00 PM EST Reads: 526
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 6, 2016 12:00 PM EST Reads: 304
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, will discuss how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved effi...
Feb. 6, 2016 12:00 PM EST Reads: 192
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 6, 2016 11:15 AM EST Reads: 122
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 6, 2016 11:15 AM EST Reads: 111
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Feb. 6, 2016 11:00 AM EST Reads: 152
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 6, 2016 11:00 AM EST
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Feb. 6, 2016 11:00 AM EST Reads: 102
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 6, 2016 11:00 AM EST
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
Feb. 6, 2016 10:00 AM EST Reads: 227
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 6, 2016 09:45 AM EST Reads: 322
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 6, 2016 09:00 AM EST