Lilly Introduces World's First Digital Insulin Pen With Memory

HumaPen MEMOIR is Sleek, High-Tech Device for Delivery of Insulin at Mealtimes

INDIANAPOLIS, February 22, 2007 -- Eli Lilly and Company today announced the launch of the first insulin pen with memory, HumaPen MEMOIR, to help simplify the daily management of diabetes.

MEMOIR is designed to meet the needs of people with diabetes who take several shots of mealtime insulin each day. It presents sophisticated technology and features in a consumer-friendly "push-to-know" digital display that allows patients to record and review their last 16 insulin doses, including the priming doses.

Many insulin users need multiple shots per day, so the ability to record doses and the time of the dose may help simplify the daily management of diabetes. This is especially important for both patients and physicians when developing a diabetes treatment plan that utilizes accurate recording of mealtime doses. MEMOIR is now available by prescription in pharmacies nationwide for use with Humalog (insulin lispro injection [rDNA origin]), the most-prescribed mealtime insulin in the United States.

Lilly also announced today that it will launch an insulin pen that delivers Humalog in smaller increments, HumaPen LUXURA HD, in April 2007. LUXURA HD is a reusable pen that can deliver from 1-to-30 units of Humalog in half-unit increments, beginning after the first unit. This type of pen may be attractive to people with diabetes that do not need large amounts of insulin, or parents of some children with diabetes. LUXURA HD will require a prescription.

Insulin pens were developed on the premise that delivery devices that are more acceptable to patients could improve patient compliance and make a positive contribution to long-term diabetes control. (1) Unlike traditional insulin pens or vial and syringe, MEMOIR doesn't resemble a medical instrument. MEMOIR, which is reusable, is sleek and designed to resemble a writing pen, enabling the potential for more discreet injections in public compared to using a vial and syringe.

In a clinical study of experienced pen users, 81 percent of patients preferred MEMOIR over the pen they were using before joining the study. MEMOIR was considered easier and more convenient to use than the pre-study pen and rated higher for certain pen features and most tasks related to dosing.1 MEMOIR was developed in partnership with Battelle Medical Device Solutions, a leader in device innovation based in Columbus, Ohio.

Of the 21 million people with diabetes in the United States, more than four million currently use insulin to help manage their blood sugar.

"I see real advantages in a new tool such as MEMOIR that remembers recent insulin doses, including the priming doses. The daily routine of balancing meals and blood sugar readings with multiple insulin injections can be cumbersome and overwhelming for patients," said Linda Siminerio, PhD, assistant professor of medicine and executive director, University of Pittsburgh Diabetes Institute; and senior vice president, International Diabetes Federation. "Anything that helps simplify the management of this disease and puts patients in a better position to self-manage is beneficial."

"As a busy college student, I'm not always thinking about how much insulin I took at my last meal," said Reuben Bresler, a 20-year-old from Columbus, Ohio, with type 1 diabetes and one of the first people in the U.S. to receive a MEMOIR pen. "MEMOIR helps me keep track of my insulin doses if I forget whether I've taken it -- or how much I took. I also like that it looks like a writing pen instead of a medical instrument. I can just take it out, use it and not feel self-conscious."

Patient Needs Drive Innovation in Device Technology

Precise meal-by-meal blood sugar management is important in diabetes management. However, despite new treatment options that have become available during the past few years, the American Diabetes Association's recommended blood sugar goal -- an A1C level of less than 7 percent -- remains elusive for many with diabetes (A1C is a measure of average blood glucose levels over a two-to-three-month period). (2) Fewer than half (43 percent) of Americans who have been diagnosed with and are being treated for diabetes are actually achieving this A1C target. (3)

To understand current behaviors and how specific pen features could help patients manage their diabetes, Lilly sponsored a national, 1,000-person telephone survey4 of people with diabetes who inject insulin at least once a day. The survey, conducted by Kelton Research in January 2007, showed that, not surprisingly, respondents were interested in new tools that could help them better manage their disease:

  • Memory can help
    • Two-thirds of respondents said a reusable pen that tracks the date, time and dose of insulin would be valuable.
    • One-third of patients reported that they forgot whether they took their insulin dose at least once a month; of these, 84 percent said a memory feature would be valuable.
    • More than 9 in 10 (94 percent) said it is important to know if they missed an insulin dose.
  • Looks matter too: Style and design considerations
    • 58 percent of those surveyed said they would be interested in using an insulin delivery device that looked like a writing pen instead of a medical instrument.
    • More than four in 10 said that a stylish looking pen would make them feel more comfortable injecting insulin in a public place.

"Individuals with diabetes face unique challenges in managing this highly complex and personal disease. Practical and innovative solutions such as Lilly's new MEMOIR pen can help ease the management of diabetes at mealtimes," said Matt Beebe, Humalog brand team leader, Lilly USA. "Our goal is to help patients more accurately and discreetly manage their use of mealtime insulin such as Humalog."

Lilly continues to develop new insulin delivery devices to meet the needs of people with diabetes. To learn more about Humalog and HumaPen MEMOIR, please visit www.Humalog.com.

Indication

Humalog is for use in patients with diabetes to control high blood sugar and should be used with a longer-acting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.

Important safety information for Humalog

Humalog should not be used during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. Safety and effectiveness in patients less than three years of age have not been established. There are no clinical studies of the use of Humalog in pregnancy or nursing mothers. Potential side effects associated with the use of all insulins include low blood sugar, weight gain, low blood potassium, changes in fat tissue at the site of injection, and allergic reactions, both general and local. Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Humalog starts working quickly because it is absorbed quickly. That's why you should use it at mealtime and take it within 15 minutes before or immediately after your meal. Because Humalog is a mealtime insulin, you may also need a longer-acting insulin to get the best blood sugar control (except when using an insulin pump).

For complete user instructions for HumaPen MEMOIR, please refer to the full user manual provided with the pen. Humalog, HumaPen MEMOIR and HumaPen LUXURA HD require a prescription.

For additional important safety information, please visit www.humalog.com.

About Diabetes

According to the Centers for Disease Control and Prevention, diabetes affects nearly 21 million Americans; of that, nearly one-third, or approximately six million people, do not know they have the disease.5 Diabetes is the sixth leading cause of death in the United States and costs approximately $132 billion per year in direct and indirect medical expenses. (5,6)

NOTES

(1) -- Venekamp, W. Functionality and Acceptability of a New Electronic Insulin Injection Pen with a Memory Feature. Current Medical Research and Opinions, 2006:22(2):315-325
(2) -- American Diabetes Association (ADA). Standards of medical care in diabetes. Diabetes Care. 2006 Jan;29 (Suppl 1):S8-17.
(3) -- Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: Quality of care in the 1990s. Ann Intern Med. 2002;136:565-574.
(4) -- The Diabetes Survey was conducted by Kelton Research between January 8th and January 16, 2007 by telephone. Quotas are set on completed interviews by geographic region, gender, and diabetes type, to ensure reliable and accurate representation of the population. Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. In this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if interviews had been conducted with all persons in the universe represented by the sample.
(5) -- Centers for Disease Control and Prevention (CDC). National diabetes fact sheet: general information and national estimates on diabetes in the United States, 2005. Rev ed. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2005.
(6) -- American Diabetes Association. Direct and indirect costs of diabetes in the United States. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed January 24, 2007.

Source: Eli Lilly and Company

Posted: February 2007


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