Hospital Pharmacy - May 2017 - 377

377

Baker

Secondary Endpoint(s)
** Achievement of HbA1c less than 7% at week 26
occurred in 75% of patients in the insulin degludec/
liraglutide group and in 36% in the unchanged GLP-1
receptor agonist group; NNT was 3. The OR for insulin degludec/liraglutide versus unchanged GLP-1
receptor agonist therapy was 6.84 (95% CI, 4.2810.94; P < .001).
** Achievement of HbA1c 6.5% or less at week 26
occurred in 63% of patients in the insulin degludec/
liraglutide group and in 23% in the unchanged GLP-1
receptor agonist group; NNT was 3. The OR for insulin degludec/liraglutide versus unchanged GLP-1
receptor agonist therapy was 7.53 (95% CI, 4.5812.38; P < .001).
** Body weight increased by 2 kg in the insulin degludec/
liraglutide group and decreased by 0.8 kg in the
unchanged GLP-1 receptor agonist group. The endof-treatment difference between the 2 groups was
2.89 kg (95% CI, 2.17-3.62; P < .001).
** Confirmed hypoglycemia occurred in both groups but
was lower in the unchanged GLP-1 receptor agonist
group. There were 2.82 episodes of confirmed hypoglycemia per patient-years of exposure in the insulin
degludec/liraglutide group and 0.12 episodes per patientyears of exposure in the unchanged GLP-1 receptor agonist group. Only 1 episode of severe hypoglycemia was
reported (in the insulin degludec/liraglutide group). The
risk of hypoglycemia was increased in both groups if a
sulfonylurea was part of the treatment regimen.
** The proportion and rates of other treatment-emergent
adverse events and serious adverse events were similar in both groups.
Comments: The study was conducted in Australia,
France, Hungary, Slovakia, and the United States. The
robustness of the primary outcome was substantiated by 3
sensitivity analyses (repeated measurement analysis, perprotocol analysis, and completer analysis), all of which
confirmed superiority of insulin degludec/liraglutide.
Limitations: This was an open-label study with a short
treatment duration (26 weeks).
Drug: Insulin Degludec/Liraglutide versus Placebo
Reference: Rodbard HW, et al, 2017 (DUAL IV trial)13
Study Design: Phase 3, randomized, double-blind, multicenter study
Study Funding: Novo Nordisk
Patients: 435 adults with type 2 diabetes inadequately
controlled with a stable daily dose of sulfonylurea (at
least half of the maximum approved dose according to
local label) with or without metformin (at least 1500 mg
or maximum tolerated dose) for at least 90 days. Patients
had a BMI of 40 kg/m2 or less and were insulin and GLP-1

receptor agonist naive. Patients were excluded if they had
received any antidiabetic agent other than sulfonylureas
or metformin within 90 days of screening. Average baseline characteristics were similar between the 2 study
groups (insulin degludec/liraglutide and placebo): Patient
age was approximately 60 years, BMI was approximately
32 kg/m2, and HbA1c was 6%. At baseline, 10.4% of
patients in the insulin degludec/liraglutide group and
11.6% in the placebo group were receiving sulfonylurea
therapy; 89.6% and 88.4%, respectively, were receiving
sulfonylurea plus metformin therapy. Of the 435 patients
randomized, 362 (83.2%) completed the study; the completion rate was 86.9% in the insulin degludec/liraglutide
group and 76% in the placebo group.
Intervention: Patients were randomized 2:1 to receive a
once-daily subcutaneous injection of insulin degludec/
liraglutide or placebo given independently of meals but
preferably at the same time each day. The dose of insulin
degludec/liraglutide was titrated twice weekly to achieve
a fasting blood glucose of 72 to 108 mg/dL. All previously prescribed sulfonylurea and metformin therapy was
continued unchanged in both groups.

Results
Primary Endpoint(s)
** HbA1c decreased from 7.9% to 6.4% in the insulin
degludec/liraglutide group and from 7.9% to 7.4% in
the placebo group. The estimated treatment difference
was −1.02% (95% CI, −1.18% to −0.87%; P < .001).

Secondary Endpoint(s)
** Achievement of HbA1c less than 7% at week 26
occurred in 79.2% of patients in the insulin degludec/
liraglutide group and in 28.8% in the placebo group;
NNT was 2. The OR for insulin degludec/liraglutide
versus placebo was 11.95 (95% CI, 7.22-19.77; P <
.001).
** Achievement of HbA1c less than 6.5% at week 26
occurred in 64% of patients in the insulin degludec/
liraglutide group and in 12.3% in the placebo group;
NNT was 2. The OR for insulin degludec/liraglutide
versus placebo was 16.36 (95% CI, 9.05-29.56; P <
.001).
** Body weight increased by 0.5 kg in the insulin
degludec/liraglutide group and decreased by 1 kg in
the placebo group; the end-of-treatment difference
between the 2 groups was 1.48 kg (95% CI, 0.9-2.06;
P < .001).
** Confirmed hypoglycemia occurred in 41.7% of
patients in the insulin degludec/liraglutide group and
in 17.1% of the placebo group. There were 3.52 episodes of confirmed hypoglycemia per patient-years of



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
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