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Diabetes Meds Update 2016 Beverly Dyck Thomassian, RN, MPH, BC ADM, CDE President, Diabetes Education Services Disclaimer and Important Info This content is for educational purposes only. Please see Package Insert for prescribing information. Beverly has no conflict of interest to disclose. For a lot more articles and information on this topic, go to DiabetesEd.net > Resources> Articles > Meds for Type 2 Diabetes Objectives Describe New Warnings on existing meds Discuss the meaning of a biosimilar insulin List the 4 available Concentrated Insulins Identify New Insulin /GLP 1 RA Combos Page 1

CDE Coach App PocketCards Updates on Existing Meds Quick Question 1: Which of the following is a new warning for the DPP IV Inhibitor? a. Contact Provider with sudden hearing loss b. Can increase risk of bladder cancer c. Increased risk of genital infections d. Report severe disabling joint pain immediately. Page 2

DPP 4 Inhibitors Incretin Enhancers Januvia (sitagliptin) Tradjenta (linagliptin) Onglyza (saxagliptin) Nesina (alogliptin) Action: Increase insulin release w/ meals Suppress glucagon Dosing: Januvia 100mg a day Onglyza up to 5mg a day Tradjenta 5mg a day Nesina up to 25 mg a day Efficacy: Decreases A1c by 0.6 0.8% Indication: For type 2s DPP IV Inhibitor Updates SGLT2 Inhibitors Glucoretics Action: Glucoretic decreases renal reabsorption in the proximal tubule of the kidneys (reset renal threshold and increase glucosuria) Efficacy: Weight loss of 1 3 lbs Reduce A1C ~0.7 1.5% f Decreases Glucose Reabsorption Page 3

EMPA REG OUTCOME : Summary Empagliflozin used in trial for 3 years in 1,000 patients with type 2 diabetes at high CV risk: Empagliflozin reduced hospitalisation for CHF 35% Empagliflozin reduced CV death by 38% Empagliflozin improved survival by reducing allcause mortality by 32% Need more research to determine this is a class effect Metformin New GFR Guidelines Page 4

Cost Per Vial in Northern CA Glargine (Basaglar) Copy Cat or Biosimilar Insulin Insulin considered a biological drug product Patent on biologicals last 12 yrs Insulin patent sold in 1923 for $1 Patent can be extended by making small improvements Insulin manufacturer s have maintained exclusivity for 93 years.. Until now Patent on glargine expired in 2015 Glargine (Basaglar) Eli Lilly Can t use the term generics for large molecule biologicals because they are manufactured in living organisms (bacteria and yeast) Each batch may be slightly different Correct term is biosimilar Currently Pharmacist to contact Provider before switching to biosimilar Future may be same as generics FDA working on standardized insulin naming system Insulin Large Molecule Aspirin Small Molecule Page 5

Are Insulin Biosimilars identicals? Degludec and Ryzodeg Degludec (Tresiba) An ultra long acting insulin lasts up to 42 hours Takes 3 4 days to reach steady state Available in u 100 and u200 pens* *200 units per ml vs 100 units per ml) Seems to cause less hypo Adjust dose every 3 4 days Wait at least 8 hours between doses Good at room temp for 8 wks Ryzodeg 70/30 mixture of insulin degludec and aspart Why Degludec (Tresiba)? Page 6

Insulin Dosing Type 1 & 2 More than 200 units a day? Page 7

Humulin Regular U 500 Consider U 500 High Potency Insulin 5 x s the concentration of u100 500 units per ml vs 100 units per ml 20 ml a vial. 500 units per ml= 10,000 units/vial Costs ~ $400 $1,200 per vial Less volume Dedicated U 500 Insulin Syringe Manufactured by BD Available in November 2016 No photos available yet U 500 Insulin FDA Post reads Page 8

U 500 Updated Package Insert All Concentrated Insulins No calculation required All concentrated insulin pens and the U 500 syringe automatically deliver the correct dose in less volume. No conversion, calculations or adjustments required. For example, if order reads: 30 units Toujeo U 300 Solostar Pen Dial the pen to 30 units. Dosing Strategies u 500 U 500 (5 x s more potent) Less volume required Dosing take total daily needs and split into 2 3 doses 2 doses: 60% am / 40% pm or 3 doses: 40/30/30 or 40/40/20 No basal insulin needed, because U 500 has bolus and basal action Needs careful monitoring/ education U-500 Insulin: When More With Less Yields Success: Diabetes Spectrum March 20, 2009 vol. 22 no. 2 116-122 Page 9

Lispro (Humalog) U 200 Kwik Pen 2 xs the concentration of U 100 Humalog U 200 Kwik Pen Comes in 3mL pen/ 600 units (2 pack) Once opened, keep at room temp. Toss after 28 days. Not approved for use in insulin pump Humalog 200 units/ml KwikPen Page 10

Glargine (Toujeo) Solostar Pen U 300 Glargine U 300 (Toujeo) vs Glargine U 100 Need 10 14% higher dose than previous U 100 dose Start with 1:1 conversion and adjust based on FBG Less nocturnal and hypoglycemia. Similar weight gain to U 100 Extend release of U 300 results in smoother, stable more prolonged profile More injection site reactions with U 300 Max 80 units injection Comes in 1.5mL pen/450 units (3 or 5 pack) Once opened, keep at room temp. Toss after 42 days. Glargine (Toujeo) Solostar Pen U 300 Glargine U 300 (Toujeo) vs Glargine U 100 Need 10 14% higher dose than previous U 100 dose Start with 1:1 conversion and adjust based on FBG Less nocturnal and hypoglycemia. Similar weight gain to U 100 Extend release of U 300 results in smoother, stable more prolonged profile More injection site reactions with U 300 Max 80 units injection Comes in 1.5mL pen/450 units (3 or 5 pack) Once opened, keep at room temp. Toss after 42 days. Toujeo U 300 Solostar Pen Page 11

Degludec (Tresiba) FlexTouch U 200 Pen Concentration 200 Units/mL Max 160 units injection Comes in 3mL pen/600 units (3 pack) Dose increments 2 units Once opened, keep at room temp. Good for 8 weeks Concentrated Insulin Pros As pts are getting heavier, more insulin is needed More insulin in less volume Patients need less insulin Cons Risk of incorrect administration Cost Making sure orders are written correctly Key Teaching Points Never withdraw concentrated insulin from a pen into a syringe All concentrated insulin pens and the U 500 insulin syringe automatically deliver the correct dose in less volume. No conversion, calculation or adjustment required. When writing Rx include type of insulin, concentration, delivery device and dose. Page 12

GLP 1 RAs + Basal Glucose GLP 1 Effects in Humans Understanding the Natural Role of Incretins GLP-1 secreted upon the ingestion of food Promotes satiety and reduces appetite Beta-cell response Beta cells: Enhances glucose-dependent insulin secretion Adapted from Flint A, et al. J Clin Invest. 1998;101:515-520 Adapted from Larsson H, et al. Acta Physiol Scand. 1997;160:413-422 Adapted from Nauck MA, et al. Diabetologia. 1996;39:1546-1553 Adapted from Drucker DJ. Diabetes. 1998;47:159-169 Alpha cells: Postprandial glucagon secretion Liver: Glucagon reduces hepatic glucose output Stomach: Helps regulate gastric emptying GLP-1 degraded by DPP-4 w/in minutes Liraglutide Approved for Weight Loss Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses Saxenda 3 mg and Victoza 1.8 mg Saxenda as a treatment option for chronic weight management in addition to a reduced calorie diet and physical activity. Saxenda is approved for use in adults with a BMI of 30 or BMI of 27 or greater who have hypertension, type 2 diabetes, or dyslipidemia. Page 13

IDegLira iglarlixi Page 14

Basal Insulin + GLP 1 RA Benefits Improved glycemic control Low risk of hypoglycemia Less weight gain Less treatment burden (one shot a day) Safe and effective alternative to basal/bolus Side Effects Hypoglycemia, weight gain (insulin) Nausea, vomiting, pancreatitis (GLP 1 RA) DiabetesEd.net > Resources Join our Meds Boot Camp Page 15

New Pocket Cards Accordion Style Soon Diabetes Ed Course Earn 32 CES 21 CEs for the Live Seminar plus 10 Bonus Online Courses, Earn 11.0 CEs we include the content that best helps you succeed at the CDE Exam and clinical practice. Plus 100+ page syllabus, healthy breakfast all days, gourmet lunches, CE certificates and a fun and engaging learning environment. Course fee of $539 Thank You Questions? Email bev@diabetesed.net Web www.diabetesed.net Page 16