INDIANAPOLIS (dpa-AFX) - Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Co. (LLY) announced results of a 52-week phase III clinical trial of the investigational agent empagliflozin, which showed statistically significant reductions in HbA1c (average blood glucose) at week 24 with the addition of empagliflozin to existing oral antihyperglycemic therapy in adults with type 2 diabetes (T2D) and mild to moderate kidney impairment.
Empagliflozin is a member of the sodium glucose co-transporter-2 (SGLT2) inhibitor class of compounds, and is being investigated for the reduction of blood glucose levels in adults with T2D. The emerging SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption by the kidney.
The company said results from the study also demonstrated a significant reduction in body weight and blood pressure with empagliflozin versus placebo in patients with mild to moderate kidney impairment.1 Adverse events (AEs) were reported in 79.6 percent, 75.4 percent and 72.7 percent of patients at 24 weeks with empagliflozin 10 mg, empagliflozin 25 mg and placebo, respectively.
Separately, Boehringer Ingelheim Pharmaceuticals and Eli Lilly announced results of a 78-week phase III clinical trial of the investigational agent empagliflozin as add-on to basal insulin in adults with type 2 diabetes or T2D. The study showed that empagliflozin 10 mg or 25 mg, plus insulin, produced statistically significant reductions in HbA1c (average blood glucose) compared with insulin alone at the study's primary endpoint, week 18, as well as at week 78.
In a separate press release, Eli Lilly 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.
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. 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.
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