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packages containing 5 pens, but needles are not included; a
new NovoFine or NovoTwist needle is needed.1
Prior to first use, the pen should be stored in the refrigerator at 2°C to 8°C (36°F-46°F). Freezing should be avoided; if
contents freeze, the pen should be discarded. After first use,
the pen can be stored at room temperature (15°C-30°C
[59°F-86°F]) but must be discarded after 21 days. The pens
should be protected from light. The needle should be removed
after each use. New needles (eg, NovoFine or NovoTwist
needles) should be used for each injection.1

Drug Safety/Risk Evaluation and
Mitigation Strategy (REMS)
A communication plan REMS is required for insulin
degludec/liraglutide.1,14

Conclusion
Insulin degludec/liraglutide is a combination of a long-acting
basal insulin and a GLP-1 receptor agonist approved as an
adjunct to diet and exercise to improve glycemic control in
adults with type 2 diabetes mellitus inadequately controlled
on basal insulin (less than 50 units daily) or liraglutide (less
than or equal to 1.8 mg daily). A factor influencing the decision to add the combination agent to the formulary will be
whether the individual ingredients are already on the formulary. This convenient combination produces better glucose
lowering and related changes in laboratory values than either
agent alone and is more convenient for patient use because it
requires 1 injection instead of 2 separate injections. There are
no head-to-head comparison studies with insulin degludec/
liraglutide and insulin glargine/lixisenatide (another longacting insulin/GLP-1 receptor agonist combination). The
role of various diabetes drugs in the treatment of patients
with established cardiovascular disease also needs to be considered; 2017 treatment guidelines indicate that empagliflozin or liraglutide therapy should be considered for these
patients.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.

References
1. Xultophy (insulin degludec/liraglutide) [prescribing information]. Plainsboro, NJ: Novo Nordisk; November 2016.
2. Soliqua (insulin glargine/lixisenatide) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; November 2016.

Hospital Pharmacy 52(5)
3. Kapitza C, Bode B, Ingwersen SH, Jacbosen LV, Poulsen
P. Preserved pharmacokinetic exposure and distinct glycemic effects of insulin degludec and liraglutide in IDegLira,
a fixed-ratio combination therapy. J Clin Pharmacol.
2015;55(12):1369-1377.
4. American Diabetes Association. Standards of medical care
in diabetes-2017: summary of revisions. Diabetes Care.
2017;40(suppl 1):S4-S5.
5. American Diabetes Association. Pharmacologic approaches
to glycemic treatment. Diabetes Care. 2017;40(suppl 1):
S64-S74.
6. Qaseem A, Barry MJ, Humphrey LL, Forciea MA, Clinical
Guidelines Committee of the American College of Physicians.
Oral pharmacologic treatment of type 2 diabetes mellitus: a
clinical practice guideline update from the American College
of Physicians. Ann Intern Med. 2017;166(4):279-290.
7. Gough SC, Bode B, Woo V, et al; NN9068-3697 (DUAL-I)
Trial Investigators. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase
3, open-label, randomised, 26-week, treat-to-target trial in
insulin-naive patients with type 2 diabetes. Lancet Diabetes
Endocrinol. 2014;2(11):885-893.
8. Gough SC, Bode BW, Woo VC, et al. One-year efficacy and
safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week
extension to a 26-week main trial. Diabetes Obes Metab.
2015;17(10):965-973.
9. Buse JB, Vilsbøll T, Thurman J, et al; NN9068-3912
(DUAL-II) Trial Investigators. Contribution of liraglutide in
the fixed-ratio combination of insulin degludec and liraglutide
(IDegLira). Diabetes Care. 2014;37(11):2926-2933.
10. Vilsbøll T, Vora J, Jarlov H, Kvist K, Blonde L. Type 2 diabetes patients reach target glycemic control faster using IDegLira
than either insulin degludec or liraglutide given alone. Clin
Drug Investig. 2016;36(4):293-303.
11. Rodbard HW, Buse JB, Woo V, et al. Benefits of combination
of insulin degludec and liraglutide are independent of baseline
glycated haemoglobin level and duration of type 2 diabetes.
Diabetes Obes Metab. 2016;18(1):40-48.
12. Linjawi S, Bode BW, Chaykin LB, et al. The efficacy of
IDegLira (insulin degludec/liraglutide combination) in adults
with type 2 diabetes inadequately controlled with a GLP-1
receptor agonist and oral therapy: DUAL III randomized clinical trial [published online ahead of print December 10. 2016].
Diabetes Ther. doi:10.1007/s13300-016-0218-3.
13. Rodbard HW, Bode BW, Harris SB, et al; Dual Action
of Liraglutide and Insulin Degludec (DUAL) IV Trial
Investigators. Safety and efficacy of insulin degludec/liraglutide (IDegLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin-naïve people with type
2 diabetes: the DUAL IV trial. Diabet Med. 2017;34(2):
189-196.
14. Guettier JM. NDA approval letter: Xultophy (insulin degludec/
liraglutide NDA 208583). U.S. Food & Drug Administration.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/20
16/208583Orig1s000ltr.pdf. Published November 21, 2016.
Accessed December 20, 2016.
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf
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