Review studies that examined the efficacy and safety of Xultophy® 100/3.6, a combination of insulin degludec and liraglutide, as well as CVOT studies in the Xultophy® 100/3.6 label. The links below will take you to the abstracts of these clinical trials on PubMed.gov, the website of the US National Library of Medicine and National Institutes of Health.
What are some key clinical studies for Xultophy® 100/3.6?
Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin: the DUAL VII randomized clinical trial
A 26-week, randomized, open-label trial in adult patients with type 2 diabetes inadequately controlled on insulin glargine U-100 (20-50 units) + metformin (N=506).1
Billings LK, Doshi A, Gouet D, et al. Diabetes Care. 2018;41(5):1009-1016.
Effect of insulin glargine up-titration vs insulin degludec/liraglutide on glycated hemoglobin levels in patients with uncontrolled type 2 diabetes: the DUAL V randomized clinical trial
A 26-week, randomized, open-label trial in adult patients with type 2 diabetes inadequately controlled on insulin glargine U-100 (20-50 units) + metformin (N=557).2,3
Lingvay I, Pérez Manghi F, García-Hernández P, et al; for the DUAL V Investigators. JAMA. 2016;315(9):898-907.
CVOT studies in the Xultophy® 100/3.6 label
Design of the liraglutide effect and action in diabetes: evaluation of cardiovascular outcome results (LEADER) trial
A phase 3B, multicenter, international, randomized, double-blind, placebo-controlled study to assess the cardiovascular safety of Victoza® (liraglutide) for patients with type 2 diabetes at high risk for cardiovascular disease (N=9340).4
Marso SP, Poulter NR, Nissen SE, et al. Am Heart J. 2013;166(5):823-830.
Efficacy and safety of degludec versus glargine in type 2 diabetes
A multicenter, multinational, randomized, double-blind, active-controlled, treat-to-target, event-driven trial in adult patients with inadequately controlled type 2 diabetes and ASCVD (N=7637).5
Marso SP, McGuire DK, Zinman B, et al. N Engl J Med. 2017;377(8):723-732.