Trulicity Labeling Updated to Include Data on T2D Patients With CKD
The prescribing information for Trulicity (dulaglutide; Eli Lilly) has been updated to include new safety and efficacy data from the AWARD-7 trial regarding patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD).
In the trial, patients who received Trulicity 0.75mg or 1.5mg in combination with mealtime insulin lispro achieved similar glycemic control with weight loss vs patients who received traditional basal-bolus insulin. Specifically, at weeks 26 and 52, both doses of Trulicity + mealtime insulin lispro demonstrated similar glycemic control vs insulin glargine + mealtime insulin lispro.
All treatment arms demonstrated a 1-1.2% reduction in HbA1c from baseline at both time endpoints. At week 26, up to 78% of all patients across each treatment group achieved target A1c levels <8%. At week 52, about 70% of patients achieved target A1c levels <8%.
Study patients who received Trulicity 1.5mg also reported weight loss of -2.8kg at week 26 and -2.7kg at week 52. Those who received Trulicity 0.75mg reported a weight loss of -2.0kg and -1.7kg at weeks 26 and 52, respectively. Patients who received insulin glargine, however, experienced weight gain (+1.1kg and +1.6kg at weeks 26 and 52, respectively).
"AWARD-7 showed that the combination of once-weekly Trulicity and mealtime insulin improved A1C as effectively as commonly used titrated basal-bolus insulin treatment, with the added benefit of weight loss," said Brad Woodward, MD, senior medical director, Lilly Diabetes.
Trulicity, a glucagon-like peptide-1 (GLP-1) receptor agonist, is a once-weekly injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It is supplied as a 0.75mg/0.5mL or 1.5mg/0.5mL pen or prefilled syringe for subcutaneous injection.
For more information call (800) 545-5979 or visit Trulicity.com.