Patients converted from basal insulin
DUAL™ II (Study B): A 26-week, randomized, parallel, double-blind, treat-to-target trial in adult patients with type 2 diabetes inadequately controlled (A1C 7.5%-10%) on basal insulin (20-40 units) and metformin ± sulfonylurea or glinides, comparing the efficacy and safety of Xultophy® 100/3.6 (n=199) with insulin degludec U-100 (n=199), both + metformin. Pretrial basal insulin, sulfonylurea, and glinides were discontinued at randomization. The primary endpoint was change in A1C after 26 weeks of treatment. Secondary endpoints included change in laboratory-measured fasting plasma glucose (FPG), dose, change in body weight, percent of patients achieving A1C <7%, and episodes of hypoglycemia.1,3
DUAL™ V (Study C): A 26-week, randomized, parallel, open-label, treat-to-target trial in adult patients with type 2 diabetes inadequately controlled (A1C 7%-10%) on insulin glargine U-100 (20-50 units) + metformin, comparing the efficacy and safety of Xultophy® 100/3.6 (n=278) with continued up-titration of insulin glargine U-100 (n=279), both + metformin. 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.1,4
DUAL™ VII: A 26-week, randomized, parallel, open-label, treat-to-target trial in adult patients with type 2 diabetes inadequately controlled (A1C 7%-10%) on insulin glargine U-100 (20-50 units) + metformin, comparing the efficacy and safety of Xultophy® 100/3.6 (n=252) with basal-bolus therapy (insulin glargine U-100 + insulin aspart [n=254]), both + metformin. 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.2
Patients converted from liraglutide
DUAL™ III (Study A): 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.1,5