Eli Lilly updates Trulicity label to show efficacy in CKD, include AWARD-7 trial
The U.S. label for Eli Lilly's once-weekly Trulicity is updated to show the medicine's safety and efficacy in people with type 2 diabetes who have moderate to severe chronic kidney disease, or CKD. The label now includes data from the AWARD-7 clinical trial, which showed that people treated with Trulicity 1.5 mg or 0.75 mg in combination with mealtime insulin lispro achieved similar glycemic control with weight loss, compared to those treated with traditional basal-bolus insulin. Trulicity is a once-weekly glucagon-like peptide-1, or GLP-1, receptor agonist, or RA, injectable prescription medicine to improve blood sugar in adults with type 2 diabetes. AWARD-7 results showed that at 26 and 52 weeks, both Trulicity doses plus mealtime insulin lispro provided similar glycemic control to insulin glargine plus mealtime insulin lispro. All treatment groups had between a 1%-2%reduction in A1C from baseline at both endpoints. At the 26-week primary endpoint, up to 78% of all study participants across each treatment group reached target A1C levels of less than 8%; at 52 weeks, approximately 70% achieved those results.