Transcript Diabetes * New and Pipeline Drugs

Anna Gibson, Pharm D.
Lead Pharmacist, Deaconess Specialty Clinics
September, 2015
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I have no actual or potential conflicts of
interest to disclose.
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Management of Hyperglycemia in Type 2
Diabetes, 2015: A Patient-Centered
Approach
Update to a Position Statement of the American
Diabetes Association and the European Association
for the Study of Diabetes
Diabetes Care 2015;38:140–149 | DOI: 10.2337/dc142441
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Individualize goals based on:
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Risks of hypoglycemia
Disease duration
Life Expectancy
Important Comorbidities
Vascular complications
Patient attitude and support system
http://diabetesmanager.pbworks.com/w/page/17680289/Oral%20Pharmacological%20Agents%20for%20Type%2
02%20Diabetes. Accessed 10/14/2014 1624.
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Potent insulin regulating hormones
◦ Released in response to glucose or fat ingestion
◦ Potentiate insulin secretion
◦ Additive effects
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Glucose-dependent insulinotropic
Polypeptide (GIP)
Glucagon-like peptide (GLP-1)
Both metabolized rapidly by DPP-4
In Type 2 diabetes, GLP secretion is
decreased and GIP-induced stimulation of
postprandial insulin secretion is diminished.
http://diabetesmanager.pbworks.com/w/page/17680289/Oral%20Pharmacological%20Agents%20for%20Type%2
02%20Diabetes. Accessed 10/14/2014 1624.
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Exenatide (Byetta®, Bydureon®)
◦ Byetta: 5-10 mcg sq BID before meals
◦ Bydureon: 2 mg sq once weekly
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Liraglutide
◦ Victoza: 0.6 – 1.8 mg SQ daily
◦ Saxenda (weight loss only): Start at 0.6 mg daily,
increase weekly to 3 mg daily
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Albiglutide (Tanzeum®)
◦ Once weekly SQ injection – 30-50 mg
◦ Powder for injection – have to mix with provided diluent
and wait 15 or 30 minutes before administration.
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Dulaglutide (Trulicity®)
◦ Once weekly SQ injection – 0.75-1.5 mg
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b.
c.
d.
Promote the release of endogenous
incretins
Inhibit the breakdown of endogenous
incretins
Act synergistically with exogenous GLP-1
agonists
Promote glucose excretion in the kidneys
a.
b.
c.
d.
Promote the release of endogenous
incretins
Inhibit the breakdown of endogenous
incretins
Act synergistically with exogenous GLP-1
agonists
Promote glucose excretion in the kidneys
http://diabetesmanager.pbworks.com/w/page/17680289/Oral%20Pharmacological%20Agents%20for%20Type%2
02%20Diabetes. Accessed 10/14/2014 1624.
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Sitagliptin (Januvia®)
◦ 100 mg daily
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Saxagliptin (Onglyza®)
◦ 2.5-5 mg daily
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Alogliptin (Nesina®)
◦ 25 mg daily
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Linagliptin (Tradjenta®)
◦ 5 mg daily
http://diabetesmanager.pbworks.com/w/page/17680289/Oral%20Pharmacological%20Agents%20for%20Type%2
02%20Diabetes. Accessed 10/14/2014 1624.
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Monotherapy or add-on.
Efficacy comparable to sulfonylurea
Weight loss
Not recommended in patients with history of
bladder cancer
Increase glucose excretion in urine –
increased risk for UTI/mycotic infections in
genital area
Diuretic effect
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Dapagliflozin (Farxiga®)
◦ 5-10 mg once daily
◦ Not recommended in creatinine clearance less than 60
ml/min
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Canagliflozin (Invokana®)
◦ 100-300 mg once daily
◦ Dose adjustment required for creatinine clearance less
than 60 ml/min, do not use in less than 45 ml/min.
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Empagliflozin (Jardiance®)
◦ 10-25 mg once daily
◦ Do not use in creatinine clearance less than 45 ml/min
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b.
c.
d.
48 year old woman, newly diagnosed type 2
diabetic with a history of chronic UTI
66 year old man, 10 year history of
diabetes, Creatinine clearance 40 ml/min
52 year old woman, 5 year history of
diabetes, previously well controlled on
metformin, now with Hgb A1C 8.4.
67 year old man with uncontrolled diabetes
who currently takes furosemide to control
hypertension
a.
b.
c.
d.
48 year old woman, newly diagnosed type 2
diabetic with a history of chronic UTI
66 year old man, 10 year history of
diabetes, Creatinine clearance 40 ml/min
52 year old woman, 5 year history of
diabetes, previously well controlled on
metformin, now with Hgb A1C 8.4.
67 year old man with uncontrolled diabetes
who currently takes furosemide to control
hypertension
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Insulin Glargine
◦ Patent on U100 (Lantus®) expired in 2/2015
 Biosimilar approved in Europe
 Submitted to FDA as new drug in US (Basaglar®)
 Tentative approval in 8/14
◦ Insulin Glargine U-300
 Toujeo®
 Longer half-life and flatter activity curve
 Less hypoglycemia
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Insulin lispro
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200 unit/ml
Humalog U-200 Kwikpen®
Not for IV use or for use in insulin pumps
Can not be mixed with any other insulins
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Insulin Peglispro
◦ Basal insulin
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Insulin Degludec (Tresiba®)
◦ Ultra long acting
◦ 100 unit/ml, 200 unit/ml – pens only
◦ 42 hour half life may allow some patients to inject
only 2-3 times per week.
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Inhaled insulin
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Afrezza®
4 units per inhalation
Contraindicated in patients with chronic lung disease
Administer at the beginning of each meal
Round up to nearest 4 units
Cough, throat pain or irritation
Teach on proper inhalation technique
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Phase 3 trials
Insulin spray
Absorbed through oral mucosa
Onset 5 minutes, peak 30 minutes, duration 2 hours
Approved in other countries, In US on Treatment IND only.
Oral insulin (Oral-Lyn®)
3 months
3 months
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Add from any class with differing mechanism
of action
May reach goal faster if initiate double
therapy at onset
◦ Consider especially if Hgb A1C > 9
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DPP-4 and GLP-1 have similar mechanisms
SGLT-2’s have not been tested with GLP-1’s
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Basal Insulin Peglispro Studies Demonstrate Superiority to Insulin Glargine Across Multiple Measures in People with Type 1 Diabetes. http://www.prnewswire.com/newsreleases/basal-insulin-peglispro-studies-demonstrate-superiority-to-insulin-glargine-across-multiple-measures-in-people-with-type-1-diabetes-300095202.html.
Accessed 8/13/15 0904.
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Buffery, MA, ABD. Specialty Drugs Top the Trends in the 2014 Pipeline. American Health & Drug Benefits. April 17, 2014. http://www.ahdbonline.com/issues/2014/march2014-volume-7-special-feature-fifth-annual-payers-guide-to-new-fda-approvals/1704-specialty-drugs-top-the-trends-in-the-2014-pipeline. Accessed 8/12/2015 1111.
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Busco, M. FDA Approves Weekly Injectable Diabetes Drug: Albiglutide. http://www.medscape.com/viewarticle/823645. Accessed 10/15/2014 1459.
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Comer, B. What’s in the pipeline for 2014?. Drug Topics. http://drugtopics.modernmedicine.com/print/379145. Accessed 9/24/2014.
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Evans, J and Rushakoff, R. Oral Agents, Incretins, and other “Non-Insulin” Pharmacologic Interventions for Diabetes.
http://diabetesmanager.pbworks.com/w/page/17680289/Oral%20Pharmacological%20Agents%20for%20Type%202%20Diabetes. Accessed 10/14/2014 1624.
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Fennel, D. Oral Insulin Conditionally Approved by FDA. http://www.diabetesselfmanagement.com/Blog/Diane-Fennell/oral-insulin-conditionally-approved-by-fda/. Accessed
10/15/2014 1633.
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Fiore, C. Sanofi submits U300 to FDA. http://www.medpagetoday.com/Endocrinology/Diabetes/46690. Accessed 10/3/2014 1415.
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Fennell, D. Oral Insuline Conditionally Approved by FDA. http://www.diabetesselfmanagement.com/blog/oral-insulin-conditionally-approved-by-fda/. Accessed 9/8/2015
1904.
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Foster, M. Basal Insulin Peglispro vs. Insulin Glargine in Type 1 Diabetes. http://www.endocrinologyadvisor.com/ada-75th-scientific-sessions-2015/insulin-peglisproglargine-type-1-diabetes/article/419161/. Accessed 9/8/2015 1900.
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Garde, D. Lilly’s new insulin is likely DOA after latest delay, analyst says. http://www.fiercebiotech.com/story/lillys-new-insulin-likely-doa-after-latest-delay-analystsays/2015-02-23. Accessed 9/8/2015
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Garde, D. Merck takes aim at Sanofi with a Lantus biosimilar of its own. http://www.fiercebiotech.com/story/merck-takes-aim-sanofi-lantus-biosimilar-its-own/2014-02-10.
Accessed 10/3/2014 1400
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Heinzman, S. ADA 2013. Sanofi will Maintain Dominance with U300. http://www.datamonitorhealthcare.com/ada2013_sanofi_u300_opinion/ Accessed 10/3/2014 1421
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Holst, Jens Juul and Orskov, Cathrine. The Incretin Approach for Diabetes Treatment. Diabetes. December 2004. Vol. 53. No suppl 3 S197-S204.
http://diabetes.diabetesjournals.org/content/53/suppl_3/S197.full. Accessed 8/12/2015 1441
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http://www.humalog.com/humalog-u200-hcp.aspx. Accessed 9/8/2015 1838
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The Incretin Effect. http://www.glucagon.com/incretineffect.html. Accessed 8/12/2015 1450.
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Inzucchi, S. et al. Management of Hyperglycemia in Type 2 Diabetes, 2015: A Patient-Centered Approach: Update to a Position Statement of the American Diabetes Associaton
and the European Association for the Study of Diabetes. DiabetesCare. January 2015 38:1 140-149;doi:10.2337/dc14-2441
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Irons, B. New Pharmacotherapies for Type 2 Diabetes. Pharmacotherapy Self Assessment Program 2013. Book 1. Cardiology/Endocrinology. American College of Clinical
Pharmacy. 2013. pp5-21.
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Lowes, R. Diabetes Drug Empagliflozin (Jardiance) wins FDA OK on second try. http://www.medscape.com/viewarticle/829326. Accessed 10/15/2014 1527.
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Nainggolan, Lisa. First Biosimilar Insulin, Glargine, Approved in EU. Medscape Multispecialty. http://www.medscape.com/viewarticle/831441. Accessed 8/12/2015 1540.
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Palmer, Eric. Novo’s Tresiba news injects uncertainty in insulin market, particularly for Sanofi. http://www.fiercepharma.com/story/novos-tresiba-news-injects-uncertaintyinsulin-market-particularly-sanofi/2015-04-08. Accessed 8/13/15 0859
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https://www.saxendapro.com/. Accessed 9/8/2015 1918
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https://www.toujeo.com/?utm_source=google&utm_medium=cpc&utm_campaign=Brand-%20Toujeo_General_Exact&utm_term=toujeo_TJOCO23027WB_86184398-VQ660841520462-VQ15-1t1-VQ16-c&moc=TJOCO23027WB. Accessed 9/8/2015 1839
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Tucker, M. FDA Approves Once-Weekly Dulaglutide for Type 2 diabetes. http://www.medscape.com/viewarticle/831969. Accessed 10/15/2014 1509.
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Tucker, M. FDA Approves Dapagliflozin (Farxiga) for Type 2 Diabetes Treatment. http://www.medscape.com/viewarticle/818858. Accessed 10/15/2014 1524.
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Tucker, M. FDA Rejects Novo Nordisk’s Insulin Degludec. http://www.medscape.com/viewarticle/779077. Accessed 9/8/2015 1906
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Diabetes and Heart Research Center. http://dhrcindia.com/diabetes_e_10.html. Accessed 10/15/2014 1642