Phase III results for Trulicity (dulaglutide) plus insulin glargine shows improvement in A1c and body weight in type 2 diabetes- Eli Lilly

New data from a completed Phase III AWARD-9 trial show Trulicity (dulaglutide) 1.5 mg, from Eli Lilly, 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 for the treatment of type 2 diabetes. 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). 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).

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). Data from the Trulicity AWARD-9 trial were presented at the 76th American Diabetes Association Scientific Sessions (ADA) in New Orleans, Louisiana.

Comment: Trulicity is approved in both the EU and USA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.