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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]

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