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Jun 24, 2013

Pharma Touts Phase III Wins for Type 2 Diabetes Drugs at ADA Gathering

  • Big pharma did not disappoint over the weekend at the American Diabetes Association’s annual meeting being held in Chicago. Boehringer Ingelheim (BI), Eli Lilly, and Sanofi were among those firms that presented promising Phase III data for type 2 diabetes (T2D) drugs.

    BI and Lilly reported results from several studies on their investigational drug empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor.

    For a trial evaluating empagliflozin as a monotherapy, the firms found that versus placebo, their compound produced statistically significant reductions in average blood glucose in adults with T2D who had never received treatment, or had not received treatment during the 12 weeks prior to initiation of the study. BI and Lilly added that it placed a subset of patients with baseline average blood glucose greater than 10%—above the study inclusion criteria—on open-label empagliflozin 25 mg for 24 weeks. In those patients, the companies observed a mean reduction in average blood glucose of 3.7% from baseline.

    In another study, the companies showed that addition of empagliflozin to existing oral antihyperglycemic therapy in patients with T2D and mild to moderate kidney impairment showed statistically significant reductions in average blood glucose.

    BI and Lilly also showed that empagliflozin added to metformin with and without the addition of sulfonylurea showed statistically significant improvements in blood glucose among T2D patients administered such treatment.

    Meantime, BI and Lilly presented results from a pooled analysis of four Phase III trials evaluating empagliflozin. Overall, the pharmas report having found that T2D patients treated with empagliflozin versus placebo achieved significant reductions in average blood glucose, fasting plasma glucose, weight, and blood pressure after 24 weeks.

    "We are primarily encouraged by the blood sugar lowering results seen in this analysis," Christophe Arbet-Engels, Ph.D., vp, metabolic-clinical development and medical affairs, Boehringer Ingelheim, said in a statement. "People with type 2 diabetes face different challenges. Many of them are not meeting their blood sugar level goals and have difficulties managing other factors such as weight and increased blood pressure."

    Separately, BI and Lilly announced results from two studies evaluating linagliptin, as monotherapy and in combination with metformin, in Asian adults with T2D. The companies found that linagliptin monotherapy demonstrated a .68% reduction in average blood glucose at 24 weeks among patients from China, Malaysia, and the Philippines, compared with a decrease of .18% in the placebo group. They also showed that, when administered in combination with metformin, linagliptin showed an average blood glucose reduction of .66% at 24 weeks among T2D patients from those same regions, versus a .14% reduction among patients in the placebo group.

    But for Lilly, the promising news did not stop at empagliflozin and linagliptin. The pharma giant also showed that its investigational GLP-1 receptor agonist dulaglutide was superior to placebo and to GLP-1 receptor agonist exenatide, metformin, and sitagliptin in reducing average blood glucose levels. Further, Lilly showed that more patients treated with its dulaglutide achieve an average blood glucose goal of less than 7% versus all comparators.

    "These results are a promising step forward in our effort to provide a new, once-weekly GLP-1 treatment option, giving patients another choice to help manage their diabetes," Lilly’s Sherry Martin, M.D., senior medical director, said in a statement. "Dulaglutide represents an important component of our diabetes portfolio, as it could help us offer a broader range of options to patients across the diabetes spectrum."

    Added Guillermo Umpierrez, M.D., professor, Emory University School of Medicine: "Dulaglutide not only demonstrated superior glycemic control in these Phase III trials, it provided this control with once-weekly dosing, which may be attractive to both patients and healthcare professionals.”

    Sanofi, too, presented promising Phase III results at the American Diabetes Association meeting.

    The firsm showed that when added to standard of care, including basal insulin with or without oral anti-diabetic agents, its investigational GLP-1 receptor agonist lixisenatide decreased average blood glucose in T2D patients by reducing postprandial glucose daytime exposure. Analyzing pooled data from 753 patients from randomized Phase III studies of lixisenatide plus standard of care versus placebo plus standard of care, Sanofi found an average reduction in blood sugar levels of .77% for lixisenatide plus standard of care versus a drop of .29% with placebo plus standard of care.

    In a statement, Oregon Health & Science University’s Matthew Riddle, M.D., professor of medicine, said that “basal insulin can control overnight glucose for people living with type 2 diabetes, but HbA1c [average blood glucose] levels may remain high due to persisting high levels of glucose during the day.” Dr. Riddle added: “This analysis suggests that once-daily lixisenatide complements the effects of basal insulin on glycemic control mainly by reducing after-meal glucose levels."


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