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.1
DUAL™ VII: Xultophy® 100/3.6 vs basal-bolus therapy
Xultophy® 100/3.6 demonstrated a similar A1C reduction vs basal-bolus therapy1
The difference in glucose lowering observed in a trial setting may not necessarily reflect what is observed in clinical practice.
aEstimated treatment difference (ETD) (95% CI): –0.02 [–0.16; 0.12]. P<0.0001, primary endpoint tested for noninferiority of Xultophy® 100/3.6 to insulin glargine U-100 + insulin aspart.
Xultophy® 100/3.6 demonstrated a similar A1C reduction with less insulin vs basal-bolus therapy1
- Average end of trial dose was 40 units of Xultophy® 100/3.6 vs 52 units basal + 32 units bolus
- Patients could not increase their basal insulin or Xultophy® 100/3.6 dose by more than 4 units per week2
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.
EPISODES OF HYPOGLYCEMIA
Xultophy® 100/3.6 resulted in less episodes of hypoglycemiab vs basal-bolus therapy1
- 89% lower rate with Xultophy® 100/3.6
- The clinical relevance of the difference in rates of severe hypoglycemia has not been established
bSevere or blood glucose (BG)-confirmed symptomatic hypoglycemia: an event requiring assistance from another person to actively administer carbohydrate, glucagon, or other resuscitative actions or BG-confirmed by a plasma glucose value (<56 mg/dL) with symptoms consistent with hypoglycemia.
Estimated rate ratio (95% CI): 0.11 [0.08; 0.17]. P<0.0001.
PYE=patient-year of exposure.
Other adverse reactions reported in ≥5% of patients on Xultophy® 100/3.6 in DUAL™ VII1
CHANGE IN BODY WEIGHT
Xultophy® 100/3.6 demonstrated weight reduction vs basal-bolus therapy1
Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.2
ETD (95% Cl): –7.87 (–9.24; –6.50), P<0.0001.