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 vs insulin glargine U-100
PRIMARY ENDPOINT
A1C REDUCTION
Significant A1C reduction vs insulin glargine U-1001


aEstimated treatment difference (ETD) (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
- 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
- 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
PATIENTS ACHIEVING A1C OF <7%:

with Xultophy®
100/3.6
VS
VS

with insulin glargine U-100


Post hoc analysis: Average A1C reductions below 7% across all baseline A1C categories3






- 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
bP=0.0002.
cP<0.0001.
SECONDARY ENDPOINTS
INSULIN DOSE
Xultophy® 100/3.6 lowered A1C with less insulin than insulin glargine U-1001

- 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

treated with Xultophy® 100/3.6 reported severe hypoglycemia2,d
dSevere 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
eETD (95% CI): –7.1 lb (–8.3; –5.81). P<0.0001.
SUMMARY
DUAL™ V RESULTS
Once-daily Xultophy® 100/3.6 vs insulin glargine U-100
Mean A1C reduction1
Patients achieving A1C <7%1
Average insulin dose1
Weight change2

-1.7%
68%
41 units
-3.1 lb
insulin glargine U-100
-1.2%
46%
66 units
+4.0 lb

Xultophy® 100/3.6
vs
insulin glargine U-100
Mean A1C reduction1
-1.7%
-1.2%
Patients achieving A1C <7%1
68%
46%
Average insulin dose1
41 units
66 units
Weight change2
-3.1 lb
+4.0 lb


Review the data from the DUAL™ V clinical trial vs insulin glargine U-100

