The following data were reported from the 72nd Scientific Sessions of the American Diabetes Association in Philadelphia last week. (Also see page 8.)

• Amylin Pharmaceuticals Inc., of San Diego, and Alkermes plc, of Dublin, Ireland, presented results from an analysis of seven randomized trials demonstrating that patients treated with Bydureon (exenatide extended-release for injectable suspension), a once-weekly treatment for Type II diabetes, experienced improvements in A1C, fasting glucose, weight and pulse pressure, regardless of their baseline body weight. The two partners also reported data showing that 44.1 percent of patients treated with Bydureon achieved target glucose levels and weight loss, compared with 11.4 percent of those treated with insulin detemir (Levemir, Novo Nordisk A/S). Patients receiving Bydureon lost an average of 5.9 pounds, while those receiving insulin detemir gained an average of 1.8 pounds. Bydureon was approved in the U.S. in January and in Europe in June 2011. (See BioWorld Today, Jan. 30, 2012.)

• Amylin Pharmaceuticals Inc., of San Diego, said that new analyses of previously reported studies of Symlin (pramlintide acetate) showed that patients with Type II or Type I diabetes had more normal blood glucose measurements when Symlin was used with insulin. The data represent a "real world" picture of how daily glucose levels are managed with the use of mealtime insulin.

• Amylin Pharmaceuticals Inc., of San Diego, and Alkermes plc, of Dublin, Ireland, reported results from a long-term extension of the DURATION-1 trial showing that Bydureon (exenatide extended-release for injectable suspension) was associated with clinically significant and sustained improvements in glycemic control over four years in adults with Type II diabetes. The study compared once-weekly Bydureon with twice-daily Byetta (exenatide) injection for 30 weeks. Following the controlled phase of the study, 258 patients entered the extension study, and 176 completed four years of treatment. Patients completing four years of treatment had significant improvements in A1C and also lost an average of 5.5 pounds, although Bydureon is not indicated for weight loss.

• New data from the European Exenatide (EUREXA) trial by Amylin Pharmaceuticals Inc., of San Diego, showed that Type II diabetes patients treated with Byetta (exenatide) injection had greater glycemic durability and overall glycemic control than those receiving Amaryl (glimepiride). The study enrolled patients inadequately controlled by metformin to receive Byetta (490 patients) or glimepiride (487 patients) as add-on therapy, with a primary endpoint of time to inadequate glycemic control (A1C more than 9 percent after three months, or more than 7 percent after six months). Forty-four percent of patients receiving Byetta achieved A1C less than 7 percent, compared to 31 percent of those treated with glimepiride.

• Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson, reported data from five Phase III trials evaluating the safety and efficacy of canagliflozin, a sodium glucose co-transporter 2 intended to treat Type II diabetes. The global Phase III program, enrolling more than 10,300 patients in nine studies, evaluated canagliflozin across the spectrum of Type 2 diabetes management. The studies evaluated canagliflozin as both monotherapy and add-on therapy to metformin, comparing it with placebo, lifestyle changes, and sitagliptin and glimepiride. Janssen submitted a new drug application to the FDA last month for canagliflozin, which it licensed from Mitsubishi Tanabe Pharma Corp., of Osaka, Japan.

• Zafgen Inc., of Cambridge, Mass., presented new data from two Phase I studies that showed beloranib, a selective methionine aminopeptidase 2 inhibitor, led to significant weight loss and improvements in cardiometabolic risk markers in severely obese women. The randomized, double-blind, placebo-controlled studies evaluated the safety, tolerability and efficacy of the drug, administered intravenously twice weekly for 25 days.