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MFLN Nutrition and Wellness New Medications for Type 2 Diabetes

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Do your patients manage their diabetes by eating well and being active? Or do they need medication to help control their blood sugar? What medications are the most effective and what is new to the market? Tune in to this webinar to guide you through what is available and most effective to help your patients better control their type 2 diabetes.

Learning Objectives:
1. Understand the current paradigm for the treatment of type 2 diabetes.

2. Compare and contrast pros and cons of newer medications for the Treatment of type 2 diabetes.

3. Modify a treatment plan correctly and efficiently based on the side effect profiles of newer medications for the treatment of type 2 diabetes.

Published in: Health & Medicine
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MFLN Nutrition and Wellness New Medications for Type 2 Diabetes

  1. 1. New Medications for Type 2 Diabetes https://learn.extension.org/events/2144 This material is based upon work supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, and the Office of Family Readiness Policy, U.S. Department of Defense under Award Numbers 2010-48869-20685, 2012-48755-20306, and 2014-48770-22587.
  2. 2. Sign up for webinar email notifications: www.extension.org/62831 Provide feedback and earn CEU credit with one link: We will provide this link at the end of the webinar
  3. 3. Research and evidenced-based professional development through engaged online communities. www.extension.org/militaryfamilies
  4. 4. Providing educational tools and caregiving tips for military professionals and family caregivers Facebook.com/MFLNNutritionWellness @MFLNNW www.youtube.com/user/MIlFamLN MFLN Nutrition and Wellness
  5. 5. Available resources https://learn.extension.org/events/2122 Find slides and additional resources under ‘event materials’
  6. 6. Main Objective Talk about new medications for the treatment of DM 1. SGLT2 inhibitors 2. GLP-1 receptor agonists 3. New insulin formulation
  7. 7. New Medications for the Treatment of Type 2 Diabetes Curtis Triplitt, PharmD, CDE Texas Diabetes Institute, University Health System Associate Professor, Clinical, University of Texas Health Science Center at San Antonio San Antonio, TX
  8. 8. Pathophysiologic Defects in Type 2 Diabetes: The Ominous Octet Decreased Incretin Effect Neurotransmitter Dysfunction Islet b-cellImpaired Insulin Secretion Decreased Glucose Uptake Islet a- cell Increased Glucagon Secretion Increased Lipolysis Increased Glucose Reabsorption Increased HGP DeFronzo RA. Diabetes. 2009;58(4):773-795. Hyperglycemia -GLP-1 agonist -DPP-4 inhibitor -SU -Insulin
  9. 9. (180 L/day) (1000 mg/L)=180 g/day 10% Glucose No Glucose S1 S3 Glucose Regulation by the Kidney 90% SGLT= Sodium-glucose co-transport SGLT-1 SGLT-2
  10. 10. Renal Glucose Handling After SGLT-2 InhibitionUrinaryGlucoseExcretion (g/day) 150 100 50 100 200 300 400 Plasma Glucose (mg/dL) Normal Threshold 0 0 Diabetes Threshold SGLT-2 Inhibition
  11. 11. Mean plasma glucose (mg/dL) Ferrannini E, et al. J Clin Invest. 2014;124:499-508. Glycosuria(g/h) SGLT2i baseline Effect of SGLT2 Inhibition on Glycosuria
  12. 12. • Canagliflozin FDA approved 2013 – 100mg or 300mg PO daily • Dapagliflozin FDA approved 2014 – 5mg or 10mg PO daily • Empagliflozin FDA approved 2014 – 10mg or 25mg PO daily SGLT2 inhibitors
  13. 13. -1 -0.8 -0.6 -0.4 -0.2 0 CANA DAPA EMPA Canagliflozin -26 week study Age:55 y.o. Duration Diabetes 6.9 years Dapagliflozin -24 week study Age:~54 y.o. Duration Diabetes: ~6 years Met: ~1800mg/day Empagliflozin -24 week study Age:~56 y.o. Duration Diabetes: Not stated (~6 years?) Met: >1500mg/day Combination with Metformin-SGLT2 inhibitors Mean Change in HbA1c from baseline(%) Lavalle-Gonzalez FJ et al. Diabetologia 2013;56:2582-2592 Bailey CJ et al. Lancet 2010; 375:2223-2233 Haring H-U et al. Diabetes Obes Metab Baseline A1C ~7.9% P 100 300 P 2.5 5 10 P 10 25 Baseline A1C ~8.0% Baseline A1C ~7.9% **NOT HEAD-TO-HEAD STUDIES**
  14. 14. -1 -0.8 -0.6 -0.4 -0.2 0 CANA DAPA EMPA Canagliflozin -52 week study Age:56 y.o. Duration Diabetes 6.6 years MET >1500mg/day Avg. GLIM 5.6mg daily Dapagliflozin -104 week study Age:~58 y.o. Duration Diabetes: ~6.3 years MET>1500mg/day Glipizide titrated Empagliflozin 52 & 104 week study, 56y.o. Background of MET EMPA or GLIM added Not stated (~6 years?) Met: >1500mg/day Combination with Sulfonylurea-SGLT2 inhibitors Mean Change in HbA1c from baseline(%) Cefalu W et al. Lancet 2013;382:941-950 Nauck MA et al. Diabetes Obes Metab 2014;16:1111-1120; Nauck et al Diabetes Care 2011;34:2015-2022 Ridderstrale M et al. Lancet Diabetes&Endocrine 2014; 2(9):691-700 GLIM 100 300 GLIP DAPA 10 GLIM EMPA Baseline A1C ~7.7% Baseline A1C 7.8% **NOT HEAD-TO-HEAD STUDIES** (-0.11%; P=0.016) 52 104104 5252 52 104104 (-0.18%); P=0.021 52 wk 52 wk 52 wk
  15. 15. Warnings/Precautions • No FDA issued Black Box Warnings • Warnings/Cautions • Genital Mycotic infections • Urinary Tract Infections • Osmotic diuretic- “water follows glucose” – Hypotension – Impaired renal function (relative) – Small increase in HCT and LDL-C • Diabetic Ketoacidosis (DKA)
  16. 16. Genital Mycotic Infections Placebo Dapagliflozin 5mg Dapagliflozin 10mg Overall number of patients, N 1393 1145 1193 Diagnosis of genital infection, n (%) 12 (0.9) 65 (5.7) 57 (4.8) History of recurrent genital infection, n (%) 10 (0.7) 13 (1.1) 12 (1.0) Prior history of recurrent genital infection with clinical diagnoses of genital infection, n (%) 1/10 (10) 3/13 (23.1) 3/12 (25.0) Women N 677 581 598 Diagnosed genital infection, n (%) 10 (1.5) 49 (8.4) 41 (6.9) Men N 716 564 595 Diagnosed genital infection, n (%) 2 (0.3) 16 (2.8) 16 (2.7)
  17. 17. Education on SGLT-2 Who Definitely Needs the Info? • Technically all patients, but especially: • History of GU infections • Uncircumcised men • GU infections in men are uncommon – More likely with very high plasma glucose – Education- often are unfamiliar with this potential, may think they have an STD
  18. 18. Urinary Tract Infections Pooled Dapagliflozin Data from 12 placebo controlled trials up to 24 weeks long Placebo Dapagliflozin 5 mg Dapagliflozin 10 mg Overall number of patients, N 1393 1145 1193 Patients with diagnosis of UTI, n (%) 52 (3.7) 65 (5.7) 51 (4.3) Patients with history of recurrent UTI, n (%) 35 (2.5) 23 (2.0) 34 (2.8) Patients with a prior history of recurrent UTI with clinical diagnoses of UTI, n (%) 6/35 (17.1) 4/23 (21.1) 6/34 (17.6) Geerlings et al. Diabetes Research and Clinical Practice 2014;103:373-381
  19. 19. Urinary Tract Infections- continued • More prevalent in women • Rates of pyelonephritis not increased: • Dapa 5mg 0.0% • Dapa 10mg 0.1% • Placebo 0.1% Geerlings et al. Diabetes Research and Clinical Practice 2014;103:373-381
  20. 20. SGLT-2 Inhibitors: Renal Dosing Canagliflozin Prescribing Information. 2013. Dapagliflozin Prescribing Information. 2014. Empagliflozin Prescribing Information 2014 Agent Dosing in CKD stages 3, 4 and 5 (non-dialysis) Canagliflozin • eGFR 45—59 ml/min/1.73m2 Do not exceed 100 mg/day PO • eGFR < 45 ml/min/1.73m2 Do not initiate and discontinue in patients currently receiving drug Dapagliflozin • eGFR <60 mL/min/1.73 m2 Do not initiate and/or discontinue Empagliflozin • eGFR < 45 ml/min/1.73m2 Do not initiate and discontinue in patients currently receiving drug. No limit on dosing • Glycemic efficacy becomes less pronounced with decreasing eGFR • If the kidney doesn’t filter as much glucose, the SGLT2i can’t prevent reabsorption
  21. 21. Canagliflozin and eGFR Yale J, et al. Poster presented at: The 73rd Scientific Session of the ADA, June 21-25, 2013, Chicago, IL.
  22. 22. Diabetic Ketoacidosis (DKA) • Unknown mechanism • Glucose values do not have to be extremely high • There will be an anion gap • Ketones will be positive • Most patients are somewhat dehydrated Practical tips for now: Do not use in Type 1 DM Do not use in LADA or “Type 1 ½” When admitted to hospital- STOP
  23. 23. What populations should we use SGLT2 inhibitors with caution? A. Blood pressure of 105/74mmHg B. Renal insufficiency(eGFR 62 mL/min/1.73m2) C. Type 1 DM D. All are correct
  24. 24. Question Break
  25. 25. Incretin Glucose Regulation DPP=dipeptidyl peptidase; GLP=glucagon-like peptide; GIP=glucose-dependent insulinotropic polypeptide or gastric inhibitory polypeptide. Drucker DJ et al. Lancet. 2006;368(9548):1696-1705.Nauck MA. Eur J Intern Med. 2009;20(2):S303- 308.Kendal DM et al. Am J Med. 2009;122(6A):S37-S50. Oral Intake of Glucose Muscle Fat Small Intestine Glucose Incretins DPP-4 enzymatic inactivation Rapid incretin inactivation Liver ↑Glucose uptake ↑Insulin ↓ Glucagon Hepatic glucose production ↓ Pancreas Glucose GLP-1 GIP DPP-4
  26. 26. GLP-1Modulate Numerous Functions in Humans Stomach: Helps regulate gastric emptying Promotes satiety and reduces appetite Liver:  Glucagon reduces hepatic glucose output (glycogenolysis) β cells: Enhances glucose- dependent insulin secretion α cells:  Postprandial glucagon secretion GLP-1: Secreted upon the ingestion of food Flint A, et al. J Clin Invest. 1998;101:515-520; Data from Drucker DJ. Diabetes. 1998;47:159-169.
  27. 27. GLP-1 Receptor Agonists • Actions: • DPP-4 inhibitors and GLP-1 receptor agonists – Increases insulin secretion in a glucose-dependent manner – Suppress inappropriate glucagon secretion ONLY GLP-1 Receptor Agonists – Slow gastric emptying – Increase satiety • Treatment options – Exenatide • Exenatide BID • Exenatide weekly – Liraglutide – Albiglutide – Dulaglutide – Flint A, et al. J Clin Invest. 1998;101:515-520; Flint A, et al. J Clin Invest. 1998;101:515-520; Data from Drucker DJ. Diabetes. 1998;47:159-169
  28. 28. Properties/Effects Long Acting GLP- 1 agonists Short-acting GLP-1 agonists DPP-4 inhibitors Administration SQ Daily or Weekly SQ Twice Daily Oral Daily Glucose-dependent insulin increase Yes Yes Yes Glucose-dependent glucagon decrease Yes Yes Yes Slows Gastric Emptying Yes Yes No Lower hypoglycemia risk (in absence of SU’s) Yes Yes Yes Effect on Body Weight Loss Loss Neutral Effect on A1C High Efficacy Moderate Efficacy Moderate Efficacy Effect on Fasting Plasma Glucose Good Modest Modest Major Adverse Effects GI, nausea GI, nausea Well-tolerated Adjustment/restriction in renal impairment No, but GI SE in renally impaired patients- Caution Yes, avoid in Severe/ ESRD Yes, varies per medication Overview of Approved Incretin Therapies
  29. 29. Differences between incretin mimetics Liraglutide Exenatide* Albiglutide Dulaglutide Dosing (SubQ) 1.2-1.8mg QD (after initial 0.6mg QDx7d) 5-10mcg within 60 min. of AM/PM meals 30-50 mg weekly 0.75-1.5mg weekly Half-life 13 hr 2-4 hr 5 days 5 days Max dose 1.8 mg 10 mcg BID 50 mg weekly 1.5mg weekly Renal elimination No Yes No No Homology to GLP-1 97% 53% 97% 90% Antibodies 8.6% 44% 2.5% 2% Other effects Less persistant nausea vs. Byetta Greater effects on FPG vs. Byetta Byetta-Greater effects on PPG (*exenatide LAR has more effect on FPG, less nausea) Nausea seems to be similar to other agents No reconstitution Available one-time use pens or pre- filled syringes
  30. 30. GLP-1 RA’s • Dose – Exenatide/Byetta® 5-10 mcg BID – Liraglutide/Victoza® start 0.6mg daily 1.2-1.8 mg QD therapeutic – Exenatide/LAR-Bydureon® 2 mg weekly – Albiglutide 30-50mg weekly – Dulaglutide 0.75-1.5mg weekly – SQ injection in thigh, abdomen or upper arm – Refrigerate unopened pens only – Prime 1st use- Byetta and Victoza • Advantages – Weight friendly – Prefilled pens – QD and weekly dosing options – Less injections (long-acting)
  31. 31. Exenatide IR and Liraglutide • Exenatide- good for post-prandial control – Compliance- make sure taking evening dose – Space more away from meal for more satiety (up to 1-2 hours prior) • Liraglutide- easy device to use – Compliance- Ask: Out of 7 injections in a week(once daily), how many are you usually able to take?
  32. 32. Albiglutide • Background – 97% homology to native GLP-1(7-36) – 2 copies of a modified GLP-1 fused to human Albumin (C- terminus end of the modified GLP-1 sequence to the N-terminus of the human albumin) – Manufactured by rDNA technology-Saccaromyces cerevisiae – Resistant to DPP-4 metabolism- glycine replaces native GLP-1 alanine – Gives a half-life of 3.6-6.8 days Eperzan, EMA, Accessed 7-9-14; http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf
  33. 33. Albiglutide- Efficacy • Study #1: 3 year data, DB, PC trial – Mean A1C 8.1%, Duration DM 4 years – A1C reduction Albi 30mg (n=30) -0.96%, SD 0.968 Albi 50mg (n=32) -1.07%, SD 0.887 Placebo(n=14) 0.61%, SD 0.644 • Study #2: Albi 50mg weekly versus Lira 1.8mg daily at week 32 – A1C- Albi -0.78%, Lira -0.99% (difference 0.21%; 0·08—0·34; non-inferiority p value=0·0846) – GI SE- Albi 36%, Lira 49% – Injection site reactions- Albi 12.9%, Lira 5.4% Rendell M et al. ADA 74th Scientific Sessions, San Francisco, June 2014, P-959, ADA 74th Scientific Sessions, San Francisco, June 2014, P-1339 Pratley RE et al. Lancet Diabetes & Endo. 2014;2:289-297
  34. 34. Albiglutide • Dosing – 30mg Weekly – May increase to 50mg weekly • Efficacy is somewhat less than others, so recommend increasing to 50mg daily when tolerated Eperzan, EMA, Accessed 7-9-14; http://www.ema.europa.eu/docs/en_GB/document_ library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf
  35. 35. Albiglutide • Side Effect Profile and Warnings • Similar to other long-acting GLP-1 RA’s – MTC-1 case of MTC with Albi and 1 case in placebo – Warnings- similar to other long-acting GLP-1 RA’s • Pancreatitis • Renal Failure- do not use if eGFR <30mL/min/1.73m2 • Hypoglycemia- if with SU, glinide, or insulin • Hypersensitivity- mild inj. site pruritis mostly, but 1 anaphylaxis in trials Package Insert, GSK 2014, accessed 7-9-14, http://www.gsksource.com/ gskprm/htdocs/documents/TANZEUM-PI-MG-IFU-COMBINED.PDF#nameddest=MG
  36. 36. Dulaglutide • Recombinant GLP-1 Fc fusion protein linking GLP-1 analog to a human IgG4 Fc fragment • Results in: – Prolonged t1/2: ~5 days – Once weekly dosing – Important: A solution-No reconstitution needed – Minimal renal clearance – Low immunogenicity risk ADA74th Scientific Sessions, San Francisco, LB-110, P-979, P-962
  37. 37. Dulaglutide Baseline (means) D vs. Lira AWARD-6 D vs. Glar AWARD-2 D vs. Glar AWARD-4 HbA1c (%) 8.1 vs. 8.1 8.1 to 8.2 8.4 to 8.5 FPG (mg/dL) 167 vs. 165 NR 150-157 Age (years) 56 vs 57 56-57 59-60 Weight (kg) 94 vs 94 85-88 91-92 Duration of Diabetes (y) 7 vs 7 ~9 12-13 Background Tx Metformin ~2grams/day Max tolerated Met and glim Poorly controlled on conventional insulin- added lispro TID to D or G ADA74th Scientific Sessions, San Francisco, LB-110, P-979, P-962 Dungan K. Lancet 11 July 2014 doi:10.1016/S0140-6736(14)60976-4
  38. 38. Dulaglutide- Results Outcomes (Means Reported) D vs. Lira AWARD-6 (26 week) D vs. Glar AWARD-2 (78 week) D vs. Glar AWARD-4 (26 week) Medication D1.5mg L1.8mg D0.75 D1.5 G D0.75 D1.5 G HbA1C (%) -1.42 -1.36 -0.62 -0.9 -0.59 -1.59 -1.64 -1.41 Wt change (kg) -2.9 -3.6 -1.54 -1.96 1.28 @wk 52 1.6 0.6 3.7 TDD Insulin n/a NR 97 93 132 % at goal <7% 68.3 67.9 NR @wk 52 56 59 49 Other Info All reported side effects comparable between tx’s PRO-less behavior & worry- hypoglycemia Glargine was ~64 units/day ADA 74th Scientific Sessions, San Francisco, LB-110, P-979, P-962 Dungan K. Lancet 11 July 2014 doi:10.1016/S0140-6736(14)60976-4
  39. 39. Dulaglutide- Side Effects Outcomes (%) D vs. Lira AWARD-6 (26 week) D vs. Glar AWARD-4 (@ 52 week) GI (%) D1.5mg L1.8mg D0.75 D1.5 G Nausea 20.4 18.0 17.7 25.8 3.4 Vomiting 7.3 8.3 10.6 12.2 1.7 Diarrhea 12.0 12.0 15.7 16.6 6.1 Injection Site Reaction 0.3 0.7 1.4 0.3 0.0 Hypoglycemia <70mg/dl +/- Sx,Events/ pt/yr 0.34 0.52 Severe 1.7 2.1 3.7 <70mg/dl 88.4 85.9 89.5 Other Info D/C due to SE 6% in each group No Pancreatitis or Pancreatic CA No Pancreatitis or Pancreatic Cancer reported ADA74th Scientific Sessions, San Francisco, LB-110, P-979, P-962 Dungan K. Lancet 11 July 2014 doi:10.1016/S0140-6736(14)60976-4
  40. 40. Question Break
  41. 41. Head-to-Head Studies: HbA1c Study Acronym Drugs Comparison HbA1C reduction (%) DURATION-1 Exenatide BID -1.5 Exenatide Weekly -1.9* DURATION-5 Exenatide BID -0.9 Exenatide Weekly -1.6* DURATION-6 Exenatide Weekly -1.28 Liraglutide -1.48* LEAD-6 Exenatide BID -0.79 Liraglutide -1.2* GetGoal-X Lixisenatide daily -0.79 Exenatide BID -0.96 *Significant difference
  42. 42. Head-to-Head Studies: HbA1c Study Acronym Drugs Comparison HbA1C reduction (%) HARMONY-7 Albiglutide -0.78 Liraglutide -0.99 AWARD-1 Dulaglutide 1.5mg weekly -1.51* Dulaglutide 0.75mg weekly -1.30* Exenatide BID -0.99 AWARD-6 Dulaglutide -1.42 (non-inferior) Liraglutide -1.36 *Significant difference Though all in the same class of medications, efficacy varies per product
  43. 43. Head-to-Head Studies: Weight Study Acronym Drugs Comparison Weight Reduction (kg) DURATION-1 Exenatide BID -3.7 Exenatide Weekly -3.6 DURATION-5 Exenatide BID Not Reported Exenatide Weekly Not Reported DURATION-6 Exenatide Weekly -2.68 Liraglutide -3.57* LEAD-6 Exenatide BID -2.87 Liraglutide -3.24 GetGoal-X Lixisenatide daily -2.96 Exenatide BID -3.98 *Significant difference
  44. 44. Head-to-Head Studies: Weight Study Acronym Drugs Comparison Weight reduction (kg) HARMONY-7 Albiglutide -0.64 Liraglutide -2.16* AWARD-1 Dulaglutide 1.5mg weekly -1.3 Dulaglutide 0.75mg weekly -0.3 Exenatide BID -1.07 AWARD-6 Dulaglutide -2.90 Liraglutide -3.61* *Significant difference Weight loss may be slightly less with albiglutide and dulaglutide Similar among other products
  45. 45. Long-term Safety Concerns • Medullary Carcinoma/C-cell hyperplasia – Rodents- only increase incidence in this model – Humans- no increased incidence to date – Possible- GLP-1 receptors on C-cell tumors • Pancreatitis – No causality, but continued association – Large observational trials do not support an increased risk • Pancreatic Cancer – No association to date Egan AG N Eng J Med 2014;370:794-797 Geir B JCEM 2012;97:121-131
  46. 46. Effect of GLP-1 RAs on CVD Risk Factors Risk Factor Exenatide 10 mcg BID (3.5 years)1 Liraglutide 1.2 mg qd (26 weeks)2 Exenatide LAR 2.0 mg qw (1 year)3 Albiglutide 30–50 mg qw (32 weeks)4 Dulaglutide 1.5 mg qw (26 weeks)5 SBP (mm Hg) –3.5* –6.7† –6.2* N/A –1.7† DBP (mm Hg) –3.3* –2.3 –2.8* N/A –0.4 TC (mg/dL) –10.8* –8.1 7.9* ND –0.8 to –8.1‡ LDL-C (mg/dL) –11.8* –10.8† –2.2 ND –1.9 to –7.0‡ HDL-C (mg/dL) 8.5* –1.2 N/A ND N/A Triglycerides (mg/dL) –44.4* –14.7† –40.0* ND –12.4 to –16.8 *P <0.05 vs baseline; †P <0.005 vs placebo; ‡P <0.001 vs placebo. 1. Klonoff DC et al. Curr Med Res Opin. 2008;24(1):275–286; 2. Zinman B et al. Diabetes Care. 2009;32(7):1224–1230; 3. Bergenstal R et al. Diabetes. 2009;58(suppl 1):165-OR; 4. Pratley RE et al. Lancet Diabetes Endocrinol. 2014;2(4):289–297; 5. Nauck MA et al. Diabetes Care. 2014;37(8):2149– 2158. N/A = not available; ND = no difference vs. placebo. Lixisenatide (not FDA approved)-Preliminary evidence-neutral for CV events
  47. 47. Injection Technique  Inject straight into the skin – Depress the button to release insulin into SQ tissue  Hold for 5 to 10 seconds before removing the needle from skin  Remove needle and dispose into sharps container  Always have the patient demonstrate their technique – At first education of the device – At first follow-up visit – At frequent intervals thereafter Inject “straight in” flush with skin
  48. 48. Exenatide BID (Byetta)  Requires a one time priming of the device  Subsequent doses can be given in the thigh, abdomen or back of the upper arms
  49. 49. Liraglutide (Victoza)  Requires a one-time priming of the device  Subsequent doses can be given in the thigh, abdomen, or back of the upper arms • Dose is dialed to this marker and the button is pressed until a drop of solution is produced • Button is held down for 6 seconds during administration
  50. 50. Exenatide LAR Weekly Kit (Bydureon)  4 parts (Single dose tray) – Needle – Vial Connector – Syringe (Diluent) – Vial (Powder)  Complex preparation  Dose can be given in the thigh, abdomen, or back of the upper arms  Dose must be given immediately  Push down on plunger until it stops
  51. 51. Exenatide LAR Weekly Pen Device(Bydureon)  Same dosing, just new device-out “later this year”  At least 15 minutes at room temperature prior to mixing steps Major steps in preparation  Twist until mix diluent with microspheres (audible click noted upon mixing)  Gently move pen back and forth (oscillate) at least 80 times (about 1- 1 ½ minutes)  Check Mixing Window for proper mixing-should see uniform grey color; If not - continue until uniform color seen in mixing window  Twist until dosing plunger comes out of knob and will hear a second “click”  Attach needle → ready for injection
  52. 52. Albiglutide (Tanzeum)  Single reconstitutable pen  Must be used within 8 hours of reconstitution • Hold pen vertically with #1 visible • Pen is turned clockwise until a click is heard and #2 appears • Gently rock the pen side to side like a window wiper five times (0° to 180°) • If 30 mg, let rest for 15 minutes and if 50 mg, let rest for 30 minutes upright • After time has elapsed, rock the pen with similar technique five more times • Solution should be yellow in appearance • Attach the supplied needle and tap the pen gently to dislodge bubbles • Turn the pen clockwise until #3 appears • Inject into thigh, abdomen, or back of the upper arms • Button is held down for 5 seconds during administration
  53. 53. Dulaglutide (Trulicity)  Single prefilled syringe – NO reconstitution necessary  Can be injected into thigh, abdomen, or back of the upper arms • Uncap the pen • Place the pen on the desired injection area • Turn the lock ring of the pen from the locked to unlocked position • Press and hold the button down for 5 - 10 seconds • The patient will hear a click when the button is pressed • A second click will indicate the dose was administered
  54. 54. Patient Education  What to expect – The most common side effects include: • Nausea (usually mild to moderate) • Diarrhea (loose stools) – Tips to minimize/eliminate nausea • Eat smaller meals, stop eating when full • Avoid overeating!!!!! • Cut down on fatty foods • Wear comfortable clothes. – Tight waistbands can make you feel worse – If nausea is severe or you have mid-abdominal pain, call your health care professional
  55. 55. GI Side Effect Management: Drug • Longer acting preparations tend to have less GI side effects • Start at lowest dose (If possible) • Short-acting: – Do not titrate dose until GI SE are gone – Exenatide BID • Take close to meals and eat slow • Long-acting: – Skip doses until GI SE are gone
  56. 56. U-300 Insulin Glargine • Only available in pens – 300 U/mL, 1.5 mL – Max dose per injection is 80 units with current pen – New pen in development will allow a max dose of 240 units – Just dial the prescribed dose; no conversion needed like U-500 • U-300 glargine pen is white and green with the concentration highlighted in orange to distinguish it from U-100 glargine 1. http://www.pdr.net/full-prescribing-information/toujeo?druglabelid=3688. Accessed March 26, 2015. 2. http://www.pdr.net/drug-summary/lantus?druglabelid=520. Accessed March 26, 2015.
  57. 57. U-300 Glargine vs U-100 Glargine in T2DM: Meta-Analysis of Phase III Trials EDITION 1, 2, & 3 Baseline to Month 6 RR (95% CI)Glar U-300 (N=1247) Glar U-100 (N=1249) A1C (%), LS mean –1.02 –1.02 NS Weight (kg), LS mean 0.49 0.75 P = 0.058 Any hypo in 24 hr* 67.8 73.8 0.92 (0.87–0.96) Any nocturnal hypo* 31.7 41.3 0.77 (0.69–0.85) Confirmed BG <54 mg/dl or severe hypo* 26.9 33.3 0.81 (0.72–0.90) Confirmed nocturnal BG <54 mg/dl or severe hypo* 9.7 13.2 0.73 (0.59–0.91) *% people ≥1 event. LS = least squares; RR = relative risk; BG = blood glucose; CI = confidence interval. Ritzel RA, et al. Presentation 963, 50th EASD Annual Meeting, September 15-19, 2014, Vienna, Austria.
  58. 58. U-300 Insulin Glargine Dosing • Insulin-Naive Patients: – Type 1 Diabetes – Start with 1/3 to 1/2 of the total daily insulin dose calculated by using 0.2-0.4 U/kg/day; give the remainder of the total daily insulin dose as a short-acting insulin and divide between each daily meal – Type 2 Diabetes – Start with 0.2 U/kg/day • Type 1 or Type 2 Diabetes: – Changing from once daily long-acting or intermediate-acting insulin: • Initial dose can be the same as the once daily long-acting dose; for patients controlled on U-100 insulin glargine, expect that a higher daily dose of U-300 glargine will be needed to maintain the same level of glycemic control – Changing from twice daily NPH insulin: • Initial dose is 80% of the total daily NPH dosage
  59. 59. What is the major side effect of GLP- 1 receptor agonists? • Medullary thyroid cancer a. Pancreatic cancer b. Osmotic diuresis c. GI side effects
  60. 60. Which of the following are side effects of SGLT2 inhibitors? a. GU mycotic infections b. Hypotension c. Slight worsening of eGFR d. Diabetic Ketoacidosis e. All of the above
  61. 61. Question Break
  62. 62. Take Home Points for Dietitians • SGLT2 inhibitors – watch fluid/electrolyte balance; signs of DKA; renal function; LDL-C • GLP-1 receptor agonists – watch/counsel for N/V/D • Glargine 300 – less risk of hypoglycemia; less weight gain
  63. 63. Disclosures Speaker’s Bureau •AstraZeneca •Boehringer Ingelheim
  64. 64. Thank You Texas Diabetes Institute, San Antonio, TX
  65. 65. Evaluation and CPEU Credit • To receive CPEU credit please complete the evaluation found at: https://vte.co1.qualtrics.com/SE/?SID=SV_8dAUCdwF VkfbOYJ *Available until August 25, 2016. The applicability of information presented today may change with new research or policies after this time.
  66. 66. MFLN Nutrition and Wellness Upcoming Event • 5-2-1-0 Healthy Messaging Campaign • Date: Tuesday, September 22 • Time: 11:00am Eastern • Location: https://learn.extension.org/events/2145 to register. • For more information on MFLN-Nutrition and Wellness go to: http://blogs.extension.org/militaryfamilies/nutrition-and-wellness/
  67. 67. Find all upcoming and recorded webinars covering: http://www.extension.org/62581 Personal Finance Military Caregiving Family Development Family Transitions Network Literacy Nutrition & Wellness Community Capacity Building This material is based upon work supported by the National Institute of Food and Agriculture, U.S. Department of Agriculture, and the Office of Family Readiness Policy, U.S. Department of Defense under Award Numbers 2010-48869-20685, 2012-48755-20306, and 2014-48770-22587.

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