INDIANAPOLIS—Approximately 382 million people worldwide have diabetes, 90 percent or more of whom deal with type 2 diabetes, according to Dr. Jessie Fahrbach, medical director for dulaglutide at Eli Lilly and Co. According to the National Diabetes Information Clearinghouse, when type 2 diabetes is diagnosed, the pancreas is usually producing enough insulin, but for unknown reasons the body cannot use the insulin effectively, a condition called insulin resistance. After several years, insulin production decreases. The end result is the same as for type 1 diabetes—glucose builds up in the blood and the body cannot make efficient use of its main source of fuel.
An article in The Lancet and a presentation at the 74th American Diabetes Association Scientific Sessions in San Francisco indicate that Eli Lilly’s once-weekly, ready-to-use injectable dulaglutide is showing its effectiveness against the disease without risking hypoglycemia. The head-to-head study compared the safety and efficacy of dulaglutide and liraglutide, two glucagon-like peptide-1 (GLP-1) receptor agonists.
Lilly, a pharmaceutical company founded in 1876, introduced the world’s first commercial insulin in 1923. It presented the results from dulaglutide’s sixth AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes) trial, showing that once-weekly dulaglutide 1.5 mg was non-inferior to once-daily liraglutide 1.8 mg, as conducted in 599 patients. Liraglutide, marketed under the brand name Victoza, was developed by Novo Nordisk.
Dulaglutide is an investigational, long-acting GLP-1 receptor agonist being studied as a treatment for type 2 diabetes. Regulatory applications were submitted to the U.S. Food and Drug Administration, European Medicines Agency and other regulatory bodies. In five Phase 3 studies, a 1.5-mg dose showed superiority over all other drugs. In the sixth study, dulaglutide matched the performance of a drug that requires daily dosing, Fahrbach says. If approved, dulaglutide will be marketed under the brand name Trulicity.
Dulaglutide and liraglutide both improve glycemic control and reduce weight in patients with type 2 diabetes. In the head-to-head trial, researchers compared the safety and efficacy of once-weekly dulaglutide with that of once-daily liraglutide in metformin-treated patients with uncontrolled type 2 diabetes. More than 4,000 people participated in the six Phase 3 studies. The most common side effect was mild to moderate nausea, which rapidly declines, according to Fahrbach.
In a Phase 3, randomized, open-label, parallel-group study at 62 sites in nine countries between June 20, 2012, and Nov. 25, 2013, patients with inadequately controlled type 2 diabetes receiving metformin were randomly assigned to receive once-weekly dulaglutide (1.5 mg) or once-daily liraglutide (1.8 mg).
Randomization was done according to a computer-generated random sequence with an interactive voice response system. Participants and investigators were not masked to treatment allocation. The primary outcome was non-inferiority of dulaglutide compared with liraglutide for change in HbA1c at 26 weeks. Safety data were collected for a further four weeks’ follow-up. Analysis was by intention to treat.
“We’re delighted by the results of the AWARD-6 trial—the first Phase 3 study in which a GLP-1 receptor agonist demonstrated non-inferiority to liraglutide,” said Dr. Sherry Martin, senior medical director for Lilly Diabetes. “If approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use. We believe it could provide patients and physicians an important new treatment option for type 2 diabetes.”
According to Dr. Kathleen Dungan, an endocrinologist and associate professor at the Ohio State University Wexner Medical Center, “Diabetes is a progressive disease that affects every patient differently. It’s important for physicians to have choices that can help their patients find a better way to manage their diabetes. These results are encouraging, as they show that dulaglutide could be a promising new treatment option for patients with type 2 diabetes.”
“We hope to hear from the regulatory agencies by the end of the year,” Fahrbach concludes.