New data from a completed phase 3 trial show Trulicity (dulaglutide) 1.5 mg significantly reduced hemoglobin A1c (A1C) and body weight as an add-on to insulin glargine without increasing the risk of low blood sugar after 28 weeks compared to placebo plus insulin glargine. Trulicity is Eli Lilly and Company's once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist that is used along with diet and exercise for the treatment of type 2 diabetes. Data from the Trulicity AWARD-9 trial were presented at the 76th American Diabetes Association Scientific Sessions (ADA) in New Orleans, Louisiana.

"Some people with type 2 diabetes require the use of more than one therapy to reach their glucose management goals and as a result, there is a concern about the risk of causing low sugar levels," said Paolo Pozzilli, M.D., professor of endocrinology and metabolic diseases at University Campus Bio-Medico in Rome, Italy and lead author. "AWARD-9 demonstrates that Trulicity may help people with diabetes who continue to experience inadequate glycemic control on insulin glargine alone reach their treatment goals."

Lilly's AWARD programme has consistently shown Trulicity's efficacy in improving glycemic control. Data from AWARD-9 builds on the available data, demonstrating Trulicity's viability for use in combination with insulin glargine to help people with type 2 diabetes reach treatment goals.

After 28 weeks of treatment, Trulicity 1.5 mg plus insulin glargine significantly reduced A1C from baseline (1.44 percent) compared to placebo with insulin glargine (0.67 percent). Also significantly more people treated with Trulicity 1.5 mg plus insulin glargine achieved an A1C of less than 7 percent (69.3 percent) compared to placebo with insulin glargine (35.1 percent).

The group treated with Trulicity 1.5 mg plus insulin glargine saw significant reductions in fasting serum glucose levels (the amount of sugar in the blood in a fasting state) with a 44.63 mg/dL reduction compared to the group treated with placebo plus insulin glargine (27.90 mg/dL reduction); and study participants treated with Trulicity 1.5 mg experienced significant weight loss (-1.91 kg) compared to participants treated with placebo plus insulin glargine, who gained weight (0.50 kg).

During the course of the study, insulin glargine was titrated using a treat-to-target algorithm in both groups; after 28 weeks, participants treated with Trulicity 1.5 mg took an average of 13.19 units less of insulin glargine than those treated with placebo plus insulin glargine (51.42 vs. 64.61 U).

The most commonly reported adverse events for people taking Trulicity in AWARD-9 were gastrointestinal-related and consistent with prior Trulicity studies, including nausea (12 percent) and diarrhea (11.3 percent). Hypoglycemia rates were similar in the Trulicity 1.5 mg plus insulin glargine group (7.69 events/patient/year) compared to those treated with placebo plus insulin glargine (8.56 events/patient/year). One severe hypoglycemic event was documented in the Trulicity 1.5 mg plus insulin glargine group.

"Despite best efforts to manage their A1C with diet and oral agents, many people with type 2 diabetes transition to injectable therapy as a natural part of the disease progression," said Zvonko Milicevic, senior medical fellow, Lilly Diabetes. "For people with type 2 diabetes who are inadequately controlled on insulin glargine alone, AWARD-9 may show that Trulicity is a treatment option that could significantly reduce A1C when used in combination with their current insulin therapy."

This phase 3, randomized, double-blind, placebo-controlled, 28-week study evaluated the efficacy and safety of once-weekly Trulicity (dulaglutide) 1.5 mg as an add-on to insulin glargine compared to placebo with insulin glargine. The primary objective of this study, in 300 patients in five countries with a mean baseline A1C of 8.4 percent, was to demonstrate superiority of Trulicity 1.5 mg to placebo on A1C reduction in type 2 diabetes patients inadequately treated with insulin glargine, with or without metformin.

Trulicity is not recommended as the first medication to treat diabetes. It has not been studied in people who have had inflammation of the pancreas (pancreatitis). Trulicity should not be used by people with a history of severe gastrointestinal (GI) disease, people with type 1 diabetes, or people with diabetic ketoacidosis. It is not a substitute for insulin. It has not been studied with long-acting insulin or in children under 18 years of age.