The difference in glucose lowering observed in a trial setting may not necessarily reflect what is observed in clinical practice.
For patients uncontrolled on insulin glargine U-100 + metformin
Significant A1C reduction vs insulin glargine U-1001
aEstimated treatment difference (95% CI): –0.51 [–0.67; –0.34]. P<0.01, primary endpoint tested for noninferiority of Xultophy® 100/3.6 to insulin glargine U-100.
- Mean FPG reduction was 50 mg/dL for both Xultophy® 100/3.6 and insulin glargine U-100 arms1
- Patients could not increase the dose of the two products by more than 4 units per week and there was no maximum allowed dose of insulin glargine U-1001
38% LESS INSULIN
needed to achieve A1C goal with Xultophy® 100/3.6 vs insulin glargine U-1001
It is unclear whether these observed differences in insulin doses are clinically important. The difference in A1C effect observed in the trial may not necessarily reflect the effect that is observed in the care setting where alternative insulin glargine U-100 dosage can be used.
- Zero of 278 patients treated with Xultophy® 100/3.6 reported severe hypoglycemia1,a
- 2.9 lb reduction in the Xultophy® 100/3.6 arm and a 4.0 lb increase in the insulin glargine U-100 arm2
Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.1
aSevere hypoglycemia: an event requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
Patients converted from insulin glargine U-100
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 safety and efficacy 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.1,3
Patients could not increase their insulin or Xultophy® 100/3.6 dose by more than 4 units per week.