Eli Lilly and Company issued the following announcement on June 25.
Eli Lilly and Company's (NYSE: LLY) Humulin® R U-500 administered via an investigational insulin pump (Omnipod® U-500™ Insulin Management System) provided greater A1C reduction with less daily insulin needed compared to multiple daily injections (MDI) in adults with type 2 diabetes on high dose insulin (201-600 units/day).1 Data from this phase 3 study will be presented for the first time today in an oral session at the American Diabetes Association (ADA) 78th Scientific Sessions® in Orlando. Humulin R U-500 is Lilly's highly concentrated insulin formulation that is used to control high blood sugar in people with diabetes who are insulin-resistant and need daily doses of more than 200 units of insulin.
"Concentrated insulins are effective treatment options for people with diabetes who have high insulin requirements," said Tom Hardy, senior medical director at Lilly. "People who prefer to use an insulin pump currently do not have an option specifically for Humulin R U-500, which is five-times concentrated. These data show that Humulin R U-500 delivered with this investigational pump may help people better manage their blood sugar levels."
At the study's primary endpoint of 26 weeks, Humulin R U-500 delivered in the investigational pump and through MDI led to A1C reductions from baseline in people with type 2 diabetes (-1.27 percent, -0.85 percent, respectively). Beginning at week eight through the duration of the study, A1C improvement was greater with the pump compared to MDI (-0.42 percent between treatment groups at the primary endpoint). Humulin R U-500 delivered in a pump also led to lower total daily insulin dose compared to MDI (difference of -0.47 units/kg at the primary endpoint).
There was no significant difference in documented symptomatic (<70 mg/dL) or severe hypoglycemia between the pump (36.9 events/patient/year; 0.12 events/patient/year) and MDI (33.9 events/patient/year; 0.05 events/patients/year). Nocturnal hypoglycemia was higher with the pump (18.2 events/patient/year) compared to MDI (11.2 events/patient/year).
"These results show that Humulin R U-500 using Insulet Corporation's Omnipod technology may help make it easier for people to titrate to their individual needs and improve their blood glucose control," said Dr. Trang Ly, senior vice president and medical director, Insulet Corporation. "We look forward to continuing to work closely with Lilly on the development of the Omnipod U-500™ Insulin Management System and bringing this new innovation to market in the near future."
Original source can be found here.