INDIANAPOLIS, June 25, 2018 /PRNewswire/ -- Eli Lilly and Company's (NYSE: LLY) Humulin® R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System) provided greater A1C reduction with less daily insulin needed compared to multiple daily injections (MDI) in adults with type 2 diabetes on high dose insulin (201-600 units/day).1 Data from this phase 3 study will be presented for the first time today in an oral session at the American Diabetes Association (ADA) 78th Scientific Sessions® in Orlando. Humulin R U-500 is Lilly's highly concentrated insulin formulation that is used to control high blood sugar in people with diabetes who are insulin-resistant and need daily doses of more than 200 units of insulin.
"Concentrated insulins are effective treatment options for people with diabetes who have high insulin requirements," said Tom Hardy, senior medical director at Lilly. "People who prefer to use an insulin pump currently do not have an option specifically for Humulin R U-500, which is five-times concentrated. These data show that Humulin R U-500 delivered with this investigational pump may help people better manage their blood sugar levels."
At the study's primary endpoint of 26 weeks, Humulin R U-500 delivered in the investigational pump and through MDI led to A1C reductions from baseline in people with type 2 diabetes (-1.27 percent, -0.85 percent, respectively). Beginning at week eight through the duration of the study, A1C improvement was greater with the pump compared to MDI (-0.42 percent between treatment groups at the primary endpoint). Humulin R U-500 delivered in a pump also led to lower total daily insulin dose compared to MDI (difference of -0.47 units/kg at the primary endpoint).1
There was no significant difference in documented symptomatic (<70 mg/dL) or severe hypoglycemia between the pump (36.9 events/patient/year; 0.12 events/patient/year) and MDI (33.9 events/patient/year; 0.05 events/patients/year). Nocturnal hypoglycemia was higher with the pump (18.2 events/patient/year) compared to MDI (11.2 events/patient/year).1
"These results show that Humulin R U-500 using Insulet Corporation's Omnipod technology may help make it easier for people to titrate to their individual needs and improve their blood glucose control," said Dr. Trang Ly, senior vice president and medical director, Insulet Corporation. "We look forward to continuing to work closely with Lilly on the development of the Omnipod U-500™ Insulin Management System and bringing this new innovation to market in the near future."
About the VIVID Study
The VIVID study was the first large, randomized, controlled study of Humulin R U-500 delivered in an insulin pump. It was an open-label, multicenter, parallel, randomized, controlled 26-week phase 3 interventional study in 420 people with type 2 diabetes on high dose insulin (201-600 units/day) with or without other diabetes medicines. The study evaluated the safety and efficacy of Humulin R U-500 delivered via Continuous Subcutaneous Insulin Infusion (CSII) to MDI. The primary objective of the study was to compare Humulin R U-500 delivered by CSII to MDI on A1C reduction from baseline.
Indication for Humulin® R U-500
Important Safety Information for Humulin® R U-500
What is the most important information I should know about Humulin R U-500?
Who should not take Humulin R U-500?
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How should I use Humulin R U-500?
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General Information about the safe and effective use of Humulin R U-500
Humulin R U-500 is available by prescription only.
For additional information, talk to your healthcare provider and please click to access Full Prescribing Information, Patient Information, and Instructions for Use for vial and pen.
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About Diabetes
Approximately 30 million Americans2 and an estimated 425 million adults worldwide have diabetes.3 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.2 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.
About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes. We offer a wide range of therapies and a continued determination to provide real solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.
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This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Humulin R U-500 delivered in an investigational insulin pump as a treatment for type 2 diabetes, and Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to date, that Humulin R U-500 will receive additional regulatory approvals or that Humulin R U-500 will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
©LillyUSA, LLC 2018. All rights reserved.
References: | |
1. |
Grunberger, G., et al. Human Regular U-500 Insulin via Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Adults with T2D: the VIVID Study – All Randomized Population. Abstract 351-OR. Presented at 78th American Diabetes Association Scientific Sessions; June 22-26, Orlando, FL. |
2. |
Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2017. Available at: https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. November 2017. |
3. |
International Diabetes Federation. IDF Diabetes Atlas, 8th edn, 2017. Available at: http://www.diabetesatlas.org/. November 2017. |
Refer to: |
DeShong Perry-Smitherman, perry_smitherman_deshong@lilly.com |
SOURCE Eli Lilly and Company