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Hospital Pharmacy 52(5)
exposure in the insulin degludec/liraglutide group and
1.35 episodes per patient-years of exposure in the placebo group. Only 2 episodes of severe hypoglycemia
were reported, both in the insulin degludec/liraglutide
group.
Comments: The study drug and placebo were added to
preexisting treatment with a sulfonylurea with or without
metformin. The goal of this study was to determine the
safety and efficacy of insulin degludec/liraglutide in insulin-naive patients with type 2 diabetes inadequately controlled on sulfonylurea therapy (glibenclamide, gliclazide,
glimepiride, and glipizide) with or without metformin.
The study was conducted in Bulgaria, Canada, Germany,
India, Israel, Turkey, and the United States. The rate of
hypoglycemia was higher in DUAL IV compared with
DUAL I, DUAL II, and DUAL III; however, all patients
were receiving a sulfonylurea in DUAL IV, and previous
studies have shown a higher risk of hypoglycemia when
liraglutide or other GLP-1 receptor agonists were combined with sulfonylurea therapy.
Limitations: The study had a short treatment duration (26
weeks).
Contraindications, Warnings, and
Precautions
Contraindications
Insulin degludec/liraglutide is contraindicated in patients with
hypersensitivity to insulin degludec, liraglutide, or any component of the formulation.1 Insulin degludec/liraglutide is contraindicated during episodes of hypoglycemia.1 Insulin degludec/
liraglutide is also contraindicated in patients with a personal or
family history of medullary thyroid carcinoma or in patients
with multiple endocrine neoplasia syndrome type 2; this is a
boxed warning and contraindication that was required for several GLP-1 receptor agonists based on animal data.1
Warnings and Precautions
Anaphylaxis and serious hypersensitivity reactions, including angioedema, may occur with insulin degludec/liraglutide. Patients with a history of these reactions with use of
other GLP-1 receptor agonists may be at risk for similar
reactions. Use of insulin degludec/liraglutide is contraindicated in patients with a previous hypersensitivity reaction to
insulin degludec, liraglutide, or any excipients of these products. If a hypersensitivity reaction occurs, insulin degludec/
liraglutide therapy should be discontinued.1
Acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, has been reported with
GLP-1 receptor agonists. Insulin degludec/liraglutide is not
recommended for patients with a history of pancreatitis. If
signs or symptoms associated with pancreatitis develop,
insulin degludec/liraglutide therapy should be discontinued
and appropriate management initiated. If pancreatitis is confirmed, it is recommended that insulin degludec/liraglutide
therapy not be restarted.1
Hypoglycemia or hyperglycemia may occur with changes
in a diabetes control regimen. When adjustments are made in
insulin degludec/liraglutide dose, the frequency of blood glucose monitoring should be increased. Adjustments in the
dose of concomitant oral antidiabetic treatment may be
needed.1 Hypoglycemia is the most common adverse reaction associated with insulin-containing products. The risk of
hypoglycemia increases with intensity of glycemic control.
Other factors that may increase the risk of hypoglycemia
include changes in meal pattern or composition, changes in
level of physical activity, changes in coadministered medication, or renal/hepatic impairment.1
Hypokalemia may occur with any insulin product.
Potassium levels should be monitored in patients at risk for
hypokalemia.1
Acute kidney injury and worsening of chronic renal failure have been reported with use of GLP-1 receptor agonists.
Renal function should be monitored when therapy is initiated
or the dose of insulin degludec/liraglutide is increased, especially in patients with renal impairment and in those reporting severe GI reactions.1
If insulin degludec/liraglutide is used concomitantly with
peroxisome proliferator-activated receptor-gamma agonists
(eg, thiazolidinediones), fluid retention and heart failure may
occur.1
Patients may develop antibodies to insulin or liraglutide.
Monitoring for antibodies is not recommended, but if the
patient fails to achieve targeted glycemic control or develops
worsening glycemic control, significant injection-site reactions, or allergic reactions, alternative antidiabetic therapy
should be considered.1
The impact of insulin degludec/liraglutide on macrovascular risk reduction has not been established.1
Thyroid C-cell tumors have been observed in rats and
mice exposed to liraglutide. It is unknown whether insulin
degludec/liraglutide causes thyroid C-cell tumors, including
medullary thyroid carcinoma.1
Insulin degludec/liraglutide pens should not be shared
between patients.1
The safety of liraglutide use during pregnancy has not
been fully established; based on animal reproduction studies,
there may be risks to the fetus associated with exposure to
liraglutide. Insulin degludec/liraglutide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.1
There are no data regarding the presence of liraglutide or
insulin degludec in human milk or their effects on breastfeeding infants or milk production. Insulin degludec and liraglutide are present in the milk of lactating rats.1
Safety and effectiveness have not been established in
pediatric patients.1
Table of Contents for the Digital Edition of Hospital Pharmacy - May 2017
Editorial, For Sale: FDA Priority Review Vouchers
Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Pharmacists’ Knowledge of the Cost of Laboratory Testing
Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 317
Hospital Pharmacy - May 2017 - 318
Hospital Pharmacy - May 2017 - 319
Hospital Pharmacy - May 2017 - 320
Hospital Pharmacy - May 2017 - 321
Hospital Pharmacy - May 2017 - 322
Hospital Pharmacy - May 2017 - 323
Hospital Pharmacy - May 2017 - Editorial, For Sale: FDA Priority Review Vouchers
Hospital Pharmacy - May 2017 - 325
Hospital Pharmacy - May 2017 - Current FDA-Related Drug Information; Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Hospital Pharmacy - May 2017 - Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings
Hospital Pharmacy - May 2017 - 328
Hospital Pharmacy - May 2017 - 329
Hospital Pharmacy - May 2017 - ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations Statin-Induced Muscle Rupture Mefloquine-Induced Rhabdomyolysis Methimazole-Induced
Hospital Pharmacy - May 2017 - 331
Hospital Pharmacy - May 2017 - 332
Hospital Pharmacy - May 2017 - 333
Hospital Pharmacy - May 2017 - Critical Care Pharmacist Market Perceptions: Comparison of Critical Care Program Directors and Directors of Pharmacy
Hospital Pharmacy - May 2017 - 335
Hospital Pharmacy - May 2017 - 336
Hospital Pharmacy - May 2017 - 337
Hospital Pharmacy - May 2017 - 338
Hospital Pharmacy - May 2017 - 339
Hospital Pharmacy - May 2017 - 340
Hospital Pharmacy - May 2017 - Capecitabine, Oxaliplatin, and Bevacizumab (BCapOx) Regimen for Metastatic Colorectal Cancer
Hospital Pharmacy - May 2017 - 342
Hospital Pharmacy - May 2017 - 343
Hospital Pharmacy - May 2017 - 344
Hospital Pharmacy - May 2017 - 345
Hospital Pharmacy - May 2017 - 346
Hospital Pharmacy - May 2017 - 347
Hospital Pharmacy - May 2017 - Clinical Pharmacy Discharge Counseling Service and the Impact on Readmission Rates in High-Risk Patients
Hospital Pharmacy - May 2017 - 349
Hospital Pharmacy - May 2017 - 350
Hospital Pharmacy - May 2017 - 351
Hospital Pharmacy - May 2017 - 352
Hospital Pharmacy - May 2017 - Mannitol Prescribing Practices With Cisplatin Before and After an Educational Newsletter Intervention
Hospital Pharmacy - May 2017 - 354
Hospital Pharmacy - May 2017 - 355
Hospital Pharmacy - May 2017 - 356
Hospital Pharmacy - May 2017 - Pharmacists’ Knowledge of the Cost of Laboratory Testing
Hospital Pharmacy - May 2017 - 358
Hospital Pharmacy - May 2017 - 359
Hospital Pharmacy - May 2017 - 360
Hospital Pharmacy - May 2017 - Adverse Drug Reaction Reporting Practices Among United Arab Emirates Pharmacists and Prescribers
Hospital Pharmacy - May 2017 - 362
Hospital Pharmacy - May 2017 - 363
Hospital Pharmacy - May 2017 - 364
Hospital Pharmacy - May 2017 - 365
Hospital Pharmacy - May 2017 - 366
Hospital Pharmacy - May 2017 - Postoperative Pain Management With Liposomal Bupivacaine in Patients Undergoing Orthopedic Knee and Hip Arthroplasty at a Community Hospital
Hospital Pharmacy - May 2017 - 368
Hospital Pharmacy - May 2017 - 369
Hospital Pharmacy - May 2017 - 370
Hospital Pharmacy - May 2017 - 371
Hospital Pharmacy - May 2017 - 372
Hospital Pharmacy - May 2017 - 373
Hospital Pharmacy - May 2017 - Formulary Drug Reviews
Hospital Pharmacy - May 2017 - 375
Hospital Pharmacy - May 2017 - 376
Hospital Pharmacy - May 2017 - 377
Hospital Pharmacy - May 2017 - 378
Hospital Pharmacy - May 2017 - 379
Hospital Pharmacy - May 2017 - 380
Hospital Pharmacy - May 2017 - 381
Hospital Pharmacy - May 2017 - 382
Hospital Pharmacy - May 2017 - 383
Hospital Pharmacy - May 2017 - 384
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