Eli Lilly and Company released detailed results from two AWARD trials that showed treatment with once-weekly dulaglutide 1.5 mg resulted in superior reductions in HbA1c from baseline compared to insulin glargine, with a lower risk for hypoglycemia.

Dulaglutide is an investigational glucagon-like peptide-1 (GLP-1) receptor agonist being studied for the treatment of type 2 diabetes. Results were presented at the 74th American Diabetes Association Scientific Sessions in San Francisco.

"Many patients with type 2 diabetes reach a point when oral medicines alone may no longer be effective enough. In these cases, many healthcare professionals choose to intensify treatment with an injectable medicine," said Francesco Giorgino, MD, professor of endocrinology and metabolism, University of Bari, Italy. "Data from these two studies comparing once-weekly dulaglutide with insulin glargine, in combination with other diabetes treatments, provide important information about a GLP-1 receptor agonist that, if approved, may be appropriate for patients with type 2 diabetes."

Results from the AWARD-2 trial, which evaluated the safety and efficacy of two doses of once-weekly dulaglutide compared to insulin glargine as add on to combination therapy with sulfonylurea and metformin, showed that once-weekly dulaglutide 1.5 mg provided superior blood sugar control at 52 and 78 weeks. Significantly more dulaglutide 1.5 mg-treated patients reached target HbA1c levels of less than 7 per cent. Further, once-weekly dulaglutide 0.75 mg was non-inferior to insulin glargine in reducing HbA1c levels.  Both doses of dulaglutide were associated with sustained weight loss, while insulin glargine showed weight gain.

Results from the AWARD-4 trial - the first phase III study to evaluate a GLP-1 receptor agonist in combination with a mealtime insulin - showed that once-weekly dulaglutide 1.5 mg and 0.75 mg combined with mealtime insulin lispro provided superior blood sugar control at 26 and 52 weeks compared to the traditional basal/bolus combination of insulin glargine and mealtime insulin lispro. Further, at the 26-week primary endpoint, significantly more dulaglutide-treated patients reached target HbA1c levels of less than 7 per cent, and patients treated with the dulaglutide-mealtime insulin lispro combination had 30 per cent less total insulin dose.  Both doses of dulaglutide, in combination with mealtime insulin lispro, were associated with relative weight benefit compared to the basal/bolus therapy of insulin glargine and mealtime insulin lispro.

Hypoglycemia rates were lower in dulaglutide 1.5 mg-treated patients compared to insulin glargine in both studies.  In AWARD-2, the 0.75 mg dose also had a lower rate of hypoglycemia compared to insulin glargine.

Adverse events were similar for dulaglutide-treated patients in both studies. The most frequently reported events were gastrointestinal-related, including nausea, diarrhea and vomiting. Nausea, which was mostly mild to moderate, was the most commonly reported event. These findings are consistent with prior studies of once-weekly dulaglutide.

"These results show that, compared to a commonly used basal insulin, once-weekly dulaglutide  improves glycemic control, provides weight benefits and has a lower risk for hypoglycemia," Sherry Martin, M.D., senior medical director, Lilly Diabetes. "If approved, dulaglutide will be the only ready-to-use, weekly GLP-1 therapy that may be an alternative for patients with type 2 diabetes who need to intensify their treatment."

Once-weekly dulaglutide, an investigational GLP-1 receptor agonist being studied as a treatment for type 2 diabetes, has been submitted to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies. Five AWARD registration trials (1-5) were submitted as part of the regulatory package. If approved, dulaglutide will be marketed under the brand name Trulicity.

AWARD-2 was a randomized, 78-week, open-label comparison of the effects of once-weekly dulaglutide and insulin glargine on glycemic control in patients with type 2 diabetes taking concurrent metformin and glimepiride. The primary objective of the study, conducted in 807 patients with poorly controlled type 2 diabetes, was to evaluate whether once-weekly dulaglutide 1.5 mg was non-inferior to insulin glargine in reducing HbA1c from baseline at 52 weeks. Insulin glargine-treated patients were titrated using a treat-to-target algorithm. Superiority testing was performed since the statistical criterion for non-inferiority was satisfied.