The label for Eli Lilly's Trulicity is updated to show its safety and efficacy in type 2 diabetes with moderate to severe chronic kidney disease.

The U.S. label for Eli Lilly and Company's once-weekly Trulicity (dulaglutide) is updated to show the medicine's safety and efficacy in people with type 2 diabetes who have moderate to severe chronic kidney disease (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 (GLP-1) receptor agonist (RA) injectable prescription medicine to improve blood sugar (glucose) in adults with type 2 diabetes. It should be used along with diet and exercise.

The Centers for Disease Control and Prevention estimate that about a third of people with diabetes may develop kidney disease. People with type 2 diabetes and moderate to severe CKD tend to have higher blood sugar levels and more advanced diabetes. Treating this population can be challenging because many diabetes treatments are either contraindicated or require dose adjustments.

AWARD-7 was the largest study of its kind for a GLP-1 RA, exclusively enrolling people with type 2 diabetes and late-stage CKD. The positive study results were published online first in The Lancet Diabetes & Endocrinology on June 14, 2018. 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 percent and 1.2 percent reduction in A1C from baseline at both endpoints. At the 26-week primary endpoint, up to 78 percent of all study participants across each treatment group reached target A1C levels of less than 8 percent; at 52 weeks, approximately 70 percent achieved those results. In addition, people in the study treated with Trulicity lost weight (Trulicity 1.5 mg: -2.8 kg, -2.7 kg, 26 and 52 weeks, respectively; Trulicity 0.75 mg: -2.0 kg, -1.7 kg, 26 and 52 weeks, respectively), while people taking insulin glargine gained weight (+1.1 kg, +1.6 kg, 26 and 52 weeks, respectively).