Xultophy® 100/3.6 is a once-daily injectable to improve glycemic control for adults with type 2 diabetes as an adjunct to diet and exercise.1
Take glycemic control a step further with Xultophy®
100/3.6 (insulin degludec and liraglutide) injection
Xultophy® 100/3.6 is a once-daily injectable to improve glycemic control for adults with type 2 diabetes as an adjunct to diet and exercise.1
Take glycemic control a step further with Xultophy® 100/3.6 (insulin degludec and liraglutide) injection
About 70% of adults with type 2 diabetes on basal insulin are not at A1C goal.2,a,b
With little or no effect on glycemic control, high insulin doses can increase the likelihood for3,c:
Increased rates of hypoglycemia
Additional weight gain
a2 years after initiation of basal insulin.
bBased on a retrospective medical records review of Humedica’s electronic records database, including 14,457 patients with type 2 diabetes.
cBased on a database of 63 insulin glargine U-100 clinical trials between 1997 and 2007, of which 15 studies met inclusion criteria (N=2837).
With little or no effect on glycemic control, high insulin doses can increase the likelihood for3,c:
Increased rates of hypoglycemia
Additional weight gain
a2 years after initiation of basal insulin.
bBased on a retrospective medical records review of Humedica’s electronic records database, including 14,457 patients with type 2 diabetes.
cBased on a database of 63 insulin glargine U-100 clinical trials between 1997 and 2007, of which 15 studies met inclusion criteria (N=2837).
DUAL VII demonstrated A1C control and additional clinical benefits for adults with type 2 diabetes taking Xultophy® 100/3.6
Comparable A1C reductions vs a basal-bolus therapy4:
Insulin glargine U-100
+ insulin aspart
PRIMARY ENDPOINT
Mean A1C reduction4,d
-1.5%
-1.5%
SECONDARY ENDPOINTS
Number of injections4,d
1 injection
At least 3 injections
Average insulin dose4,e
40 units
84 units
Severe or BG-confirmed symptomatic hypoglycemia reported4,f,g
1.1 events/PYE
8.2 events/PYE
Weight change4,h
7.9 LB DIFFERENCE
-2.0 lb
+5.7 lb
Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.4
dThe difference in A1C effect observed in the trial may not necessarily reflect the effect that may be observed in the care setting where alternative insulin glargine and insulin aspart dosage can be used.
eThe pretrial dose of insulin was 34 units in the Xultophy® 100/3.6 arm and 33 units in the basal-bolus arm. Patients could not increase their basal insulin or Xultophy® 100/3.6 doses by more than 4 units per week and they could not increase their insulin aspart doses by more than 2 units per injection per week. Average end-of-trial dose was 40 units of Xultophy® 100/3.6 vs 52 units basal + 32 units bolus.
fSevere or 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.
gThe clinical relevance of the difference in rates of severe hypoglycemia has not been established.
hXultophy® 100/3.6 is not indicated for weight loss. Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.4
BG=blood glucose; CI=confidence index; ERR=estimated rate ratio; MET=metformin; PYE=patient-year of exposure.
Adverse reactions
were
reported in ≥5% of patients on
Xultophy®
100/3.61
ADVERSE REACTIONS
XULTOPHY® 100/3.6
N=1881
Nasopharyngitis
9.6
Headache
9.1
Nausea
7.8
Diarrhea
7.5
Increased Lipase
6.7
Upper respiratory tract infection
5.7
DUAL VII demonstrated A1C control and additional clinical benefits for adults with type 2 diabetes taking Xultophy® 100/3.6
Comparable A1C reductions vs a basal-bolus therapy4:
PRIMARY ENDPOINT
Mean A1C reduction4,d
-1.5%
SECONDARY ENDPOINTS
Number of injections4,d
1 injection
Average insulin dose4,e
40 units
Severe or BG-confirmed symptomatic hypoglycemia reported4,f,g
1.1 events/PYE
Weight change4,h
-2.0 lb
Insulin glargine U-100
+ insulin aspart
PRIMARY ENDPOINT
Mean A1C reduction4,e
-1.5%
-1.5%
Number of injections4
1 injection
At least 3 injections
Average insulin dose4,g
40 units
84 units
PRIMARY ENDPOINT
Mean A1C reduction4,d
-1.5%
SECONDARY ENDPOINTS
Number of injections4,d
At least 3 injections
Average insulin dose4,e
84 units
Severe or BG-confirmed symptomatic hypoglycemia reported4,f,g
8.2 events/PYE
Weight change4,h
+5.7 lb
Severe or BG-confirmed symptomatic hypoglycemia reported4,f
1.1 events/PYE
8.2 events/PYE
Severe or BG-confirmed symptomatic hypoglycemia reported4,f
1.1 events/PYE
8.2 events/PYE
Weight change4
-2.0 lb
+5.7 lb
Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.4
dThe difference in A1C effect observed in the trial may not necessarily reflect the effect that may be observed in the care setting where alternative insulin glargine and insulin aspart dosage can be used.
eThe pretrial dose of insulin was 34 units in the Xultophy® 100/3.6 arm and 33 units in the basal-bolus arm. Patients could not increase their basal insulin or Xultophy® 100/3.6 doses by more than 4 units per week and they could not increase their insulin aspart doses by more than 2 units per injection per week. Average end-of-trial dose was 40 units of Xultophy® 100/3.6 vs 52 units basal + 32 units bolus.
fSevere or 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.
gThe clinical relevance of the difference in rates of severe hypoglycemia has not been established.
hXultophy® 100/3.6 is not indicated for weight loss. Weight gain can occur with insulin-containing products, including Xultophy® 100/3.6, and has been attributed to the anabolic effects of insulin.4
BG=blood glucose; CI=confidence index; ERR=estimated rate ratio; MET=metformin; PYE=patient-year of exposure.
Adverse reactions were reported in ≥5% of patients on Xultophy® 100/3.61
ADVERSE REACTIONS
XULTOPHY® 100/3.6
N=1881
Nasopharyngitis
9.6
Headache
9.1
Nausea
7.8
Diarrhea
7.5
Increased Lipase
6.7
Upper respiratory tract infection
5.7
6.7
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 daily) + 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.4
Explore coverage options for patients who are new to Xultophy® 100/3.6, including our formulary tool and supports.
References:
- Xultophy 100/3.6 [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Curtis B, Lage MJ. Glycemic control among patients with type 2 diabetes who initiate basal insulin: a retrospective cohort study. J Med Econ. 2014;17(1):21-31.
- Reid T, Gao L, Gill J, et al. How much is too much? Outcomes in patients using high-dose insulin glargine. Int J Clin Pract. 2016;70(1):56-65.
- Billings LK, Doshi A, Gouet D, et al. Efficacy and safety of IDegLira versus basal-bolus insulin therapy in patients with type 2 diabetes uncontrolled on metformin and basal insulin: the DUAL VII randomized clinical trial. Diabetes Care. 2018;41(5):1009-1016.