Follow-up Phase II Data Analysis Adds to Body of Evidence for Investigational Novel Basal Insulin, LY2605541

CHICAGO, June 22, 2013 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced results from an additional analysis of Phase II clinical data for LY2605541, an investigational novel basal insulin analog. The analysis provides more in-depth information about the reductions in required prandial (mealtime) insulin in LY2605541-treated patients compared to those treated with insulin glargine.[1] These findings are being presented at the 73^rd American Diabetes Association Scientific Sessions^® in Chicago, June 21–25, 2013.

Initial clinical data from a Phase II study showed that LY2605541-treated patients with type 1 diabetes had greater improvements in glycemic control along with reduced mealtime insulin doses compared to insulin glargine-treated patients.[2] Results from this additional analysis showed that among those who completed the Phase II study, which included eight weeks of treatment with LY2605541 and eight weeks of insulin glargine, LY2605541 led to significantly lower average blood glucose levels (143.1 mg/dL vs. 151.7 mg/dL) with statistically significantly less mealtime insulin per day compared to insulin glargine. The reduced mealtime insulin use was found per day and across all major meals, including:

• breakfast (-0.9 +/- 0.4 International Units (IU) [13.7 percent reduction]),
• lunch (-1.4 +/- 0.4 IU [18.6 percent reduction]),
• dinner (-2.0 +/- 0.4 IU [22.4 percent reduction]), and 
• total daily dose (-4.3 +/- 1.5 IU) [20.7 percent reduction in units]).[1]

LY2605541-treated patients had a statistically higher overall hypoglycemia rate (blood glucose less than or equal to 70 mg/dL) compared to insulin glargine (9.2 vs. 8.1 events/30 days) but a statistically lower rate of nocturnal hypoglycemia (0.9 vs. 1.2 events/30 days). Hypoglycemia rates in LY2605541-treated patients were statistically higher during some daytime and evenings, which resulted in the need to reduce mealtime insulin doses during the study.[1]

"This additional analysis showed that patients treated with LY2605541 achieved effective glycemic control with less mealtime insulin, which is exciting because it further supports our hypothesis that LY2605541 has a novel mechanism of action," said David Kendall, M.D., distinguished medical fellow, Lilly Diabetes. "We are encouraged by the potential benefits LY2605541 may offer patients and are pleased that our data support its ongoing development."

LY2605541, which was discovered and developed in Lilly Research Laboratories, is currently in Phase III clinical trials, and is among several diabetes molecules in Lilly's late-stage pipeline. The company has approximately a dozen potential new medicines for the treatment of diabetes and its related conditions, encompassing both large and small molecules, and targeting a variety of mechanisms.

About the Phase II Study Analysis
The Phase II, randomized, open-label, 2x2 crossover study evaluated whether LY2605541 was non-inferior (similar) to insulin glargine in reducing daily mean blood glucose in adults with type 1 diabetes. One hundred thirty-seven patients received LY2605541 or insulin glargine once daily, plus mealtime insulin, for eight weeks; they then switched treatments for an additional eight weeks. Daily mean blood glucose values were obtained from self-monitoring of blood glucose (SMBG) profiles (blood glucose readings before and two hours after a meal, at bedtime and at 3 a.m.) collected on three separate days the week prior to each visit. Hypoglycemic events (i.e., blood glucose less than 70 mg/dL) were captured throughout the study. All insulins were adjusted to optimize glycemic control.

The additional analysis further explored an initial observation of reduced mealtime insulin requirements for type 1 diabetes patients treated with LY2605541 versus insulin glargine.

About Diabetes
Approximately 25.8 million Americans[3] and an estimated 371 million people[4] 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.[5]

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 work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and our 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, IN, 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 an investigational compound, novel basal insulin LY2605541, which is currently in development for the treatment of diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that novel basal insulin LY2605541 will receive required regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

[1] Rosenstock J, Bergenstal RM, Blevins T, Morrow L, Qu Y, Jacober SJ. Improved glycemic control despite reduction in bolus insulin doses with basal insulin LY2605541 compared with basal insulin glargine in patients with type 1 diabetes. Abstract 915-P. Presented at: American Diabetes Association (ADA) 73rd Scientific Sessions; June 21–25, 2013; Chicago, IL.

[2] Rosenstock J, et al. Better Glycemic Control and Weight Loss With the Novel Long-Acting Basal Insulin LY2605541 Compared With Insulin Glargine in Type 1 Diabetes: A randomized, crossover study. Diabetes Care. 2013; 36(3): 522–528.

[3] 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.

[4] International Diabetes Federation. Diabetes Atlas, 5th Edition: Fact Sheet. 2012.

[5] International Diabetes Federation. Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: February 22, 2012.

Refer to: Tamara Hull, +1-317-651-9116, [email protected]

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SOURCE Eli Lilly and Company