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.1,2
DUAL™ V: Xultophy® 100/3.6 demonstrated significant A1C reduction vs insulin glargine U‑1001
Significant A1C reduction vs insulin glargine U-1001
aEstimated treatment difference (ETD) (95% CI): –0.51 (–0.67; –0.34). P<0.01.
- The difference in A1C effect observed in the trial may not necessarily reflect the effect that will be observed in the care setting where alternative insulin glargine dosage can be used
Post hoc analysis: Average A1C reductions below 7% across all baseline A1C categories with Xultophy® 100/3.63
- The post hoc analysis aimed to confirm the efficacy of Xultophy® 100/3.6 vs insulin glargine U-100 across categories of baseline A1C
- Overall, Xultophy® 100/3.6 had a baseline A1C of 8.4% with an end of trial A1C of 6.6% (n=278) vs insulin glargine U-100 which had a baseline A1C of 8.2% with an end of trial A1C of 7.1% (n=279). ETD: –0.51% [–0.67;–0.34]; P<0.011
Post hoc analysis: Average A1C reductions below 7% regardless of pretrial insulin dose4
EOT=end of trial.
Xultophy® 100/3.6 lowered A1C with less insulin than insulin glargine U-1001
- The average pretrial insulin glargine U-100 dose was 31 units in the Xultophy® 100/3.6 arm and 32 units in the insulin glargine U-100 arm2
- End of trial dose was 41 units of Xultophy® 100/3.6 vs 66 units of insulin glargine U-100
- Patients could not increase the dose of the 2 products by more than 4 units per week and there was no maximum dose of insulin glargine U-1001
It is unclear whether these observed differences in insulin doses are clinically important.
EPISODES OF HYPOGLYCEMIA
Rate of severe hypoglycemiae reported in the Xultophy® 100/3.6 arm1,2
treated with Xultophy® 100/3.6 reported severe hypoglycemia2,e
eSevere hypoglycemia: an event requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
CHANGE IN BODY WEIGHT
Xultophy® 100/3.6 demonstrated weight reduction vs insulin glargine U-1002
Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.1
fETD (95% CI): –7.1 lb (–8.3; –5.81). P<0.0001.