A 26-week, randomized, open-label, treat-to-target trial in insulin-naïve adult patients with type 2 diabetes inadequately controlled (A1C 7%-9%) on up to 1.8 mg of liraglutide + metformin ± pioglitazone ± sulfonylurea, comparing the efficacy and safety of Xultophy® 100/3.6 (n=232) with unchanged liraglutide (n=116). All pretrial oral antidiabetic (OAD) therapies were continued throughout the trial. The primary endpoint was change in A1C after 26 weeks of treatment. Secondary endpoints included change in laboratory-measured FPG, dose, change in body weight, percent of patients achieving A1C <7%, and episodes of hypoglycemia.1,2
For patients uncontrolled on liraglutide ≤1.8 mg + MET ± PIO ± SU
Significant A1C reduction vs liraglutide1
aEstimated treatment difference (95% CI): –0.95 (–1.15; –0.75). P<0.0001.
- Average end of trial dose for Xultophy®100/3.6 was 44 units1
- One of 291 patients (0.3%) treated with Xultophy® 100/3.6 reported severe hypoglycemia1,2,b
- 4.4 lb increase in the Xultophy® 100/3.6 arm and a 1.6 lb reduction in the liraglutide arm1,3
bSevere hypoglycemia: an event requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions.