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Follow-up Phase II Data Analysis Adds to Body of Evidence for Investigational Novel Basal Insulin, LY2605541
Date:6/22/2013

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.

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