The Alphabet Soup of Diabetes. Egils Bogdanovics M.D. Hungerford Diabetes Center

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1 The Alphabet Soup of Diabetes Egils Bogdanovics M.D. Hungerford Diabetes Center

2

3 Insulin: January 11, year old Leonard Thompson, on a starvation diet for 2 years received his first insulin injection A thick brown muck prepared by Banting and Best 7.5cc in each buttock lowered glucose from 440 to 320 and resulted in an abscess at each injection site

4 Facts Every 5 seconds 1 person develops diabetes Every 10 seconds 1 person dies of diabetes Every 30 seconds a limb is lost to diabetes Diabetes is a chronic, debilitating and costly disease associated with severe complications, which poses severe risks for families, Member States and the entire world. UN Resolution 61/225. World Diabetes Day

5 Pathogenesis of Type 2 Diabetes Islet b-cell Impaired Insulin Secretion Increased HGP Decreased Glucose Uptake HGP=hepatic glucose production.

6 The Ominous Octet Islet b-cell Impaired Insulin Secretion Decreased Incretin Effect Increased Lipolysis Islet a-cell Increased Glucagon Secretion Increased Glucose Reabsorption Increased HGP Neurotransmitter Dysfunction Decreased Glucose Uptake DeFronzo RA Diabetes 2009

7 Plasma glucose (mg/dl) Insulin (mu/l) Plasma glucose (mg/dl) Insulin (mu/l) Incretin Effect Is Reduced in Type 2 Diabetes 270 Controls 80 Oral glucose load IV glucose infusion Incretin effect * * * * * * * Time (min) Type 2 Diabetes Time (min) * * * Time (min) *P 0.05 compared with respective value after oral load. Reproduced from Nauck M et al. Diabetologia. 1986;29: Time (min)

8 pg/ml mcu/ml mg/dl Post-Meal Glucose Control Is Impaired in Type 2 Diabetes Due to Insufficient Insulin and Elevated Glucagon Carbohydrate meal Glucose Type 2 diabetes Normal glucose tolerance 50 0 Insulin Glucagon Time (min) Reproduced from Müller WA et al. N Engl J Med. 1970;283:

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10 Renal Threshold for Glucose Excretion in Healthy Subjects

11 Renal Threshold for Glucose Excretion in T2DM: Increased

12 2016: 12 Classes of Drugs for Diabetes Medication Route of Administration Year of approval HbA1c reduction with monotherapy Insulin Parenteral 1921 >2.5 Sulfonylureas Oral Metformin Oral Alpha-glucosidase inhibitors Oral Thiazoladenediones Oral Metiglinides Oral GLP-1 analogs Parenteral Amylin Analogs Parenteral DPP-IV inhibitors Oral Colesevelam Oral Bromocriptine Oral SGLT2 inhibitors Oral

13 Approach to the Management of Hyperglycemia Patient/Disease Features Risks associated with hypoglycemia & other drug adverse effects Disease Duration Life expectancy Important comorbidities Established vascular complications more stringent low newly diagnosed long absent absent A1C 7% Few/mild Few/mild less stringent high long-standing short severe severe Patient attitude & expected treatment efforts Resources & support system highly motivated, adherent, excellent self-care capabilities readily available less motivated, nonadherent, poor self-care capabilities limited American Diabetes Association Standards of Medical Care in Diabetes. Glycemic targets. Diabetes Care 2016; 39 (Suppl. 1): S39-S46

14 Metformin 1995 First line therapy Weight neutral or negative No hypoglycemia risk Reduces liver glucose production DC if egfr <30 Not rec to start if <45

15 Sulfonylureas The right dose differentiates a poison from a useful medicine Paracelsus

16 ADA/EASD General Recommendations for Hyperglycemia Management

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18 Type 2 Diabetes and Glucagon One wonders if the development of a pharmacological means of suppressing glucagon to appropriate levels would not increase the effectiveness of available insulin, markedly reduce insulin requirements, and perhaps improve control of the diabetic state. Unger RH, NEJM 1971

19 Exendin-4: Exocrine gland Endocrine function Heloderma suspectum

20 GLP1 Receptor Agonists Byetta; Bydureon exenatide Victoza liraglutide Tanzeum albiglutide Trulicity dulaglutide semaglutide

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22 Patients with an event (%) LEADER trial: Primary Outcome First occurrence of CV death, nonfatal myocardial infarction, or nonfatal stroke in the time-to-event analysis in patients with type 2 diabetes and high CV risk Hazard ratio, 0.87 (95% CI, ) P<0.001 for noninferiority P=0.01 for superiority 10 5 Placebo Liraglutide Months since randomisation Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial Adapted from: Marso SP et al., NEJM 2016

23 Patients with an event (%) LEADER trial: Death from Cardiovascular Causes 20 Hazard ratio, 0.78 (95% CI, ) P= Placebo Liraglutide Months since randomisation Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial Adapted from: Marso SP et al., NEJM 2016

24 Marso SP et al. N Engl J Med DOI: /NEJMoa Semaglutide Cardiovascular Outcomes.

25 Newest Class: Sodium Glucose Transporter 2 Inhibitors

26 Phlorizin 1835

27 Familial Renal Glucosuria SLCA2 gene mutations Persistent UGE <0.1 to >100 g/day No hyperglycemia or diabetes

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29

30 Renal Threshold for Glucose Excretion in T2DM: Increased

31 SGLT2 Inhibition Lowers Renal Threshold for Glucose Excretion

32 SGLT2 Inhibitors INVOKANA canagliflozin FARXIGA dapagliflozin JARDIANCE empagliflozin sotagliflozin

33 Mean change from baseline in body weight (kg) SGLT2 Inhibitors and Body Weight Mean Body Weight Reduction Dapagliflozin 10mg Canagliflozin 300 mg Mean Body Fat Loss Control Data presented are not from head-to-head studies Ferrannini E et al. Diabetes Care. 2010;33: Bailey CJ et al. Lancet. 2010;375: Stenlof K et al. Diabetes Obes Metab. 2013;15: Rosenstock J et al. Diabetes Care. 2012;35: Wilding JP et al. Int J Clin Pract. 2013;67: Bolinder J et al. Diabetes Obes Metab. 2014;16:

34 Pressure change from baseline (mmhg) SGLT2 Inhibitors and Blood Pressure Dapagliflozin 10 mg Canagliflozin 300 mg * ** * P<0.001 vs PBO ** P<0.001 vs sitagliptin a Comparison not specified Ferrannini E et al. Diabetes Care. 2010;33: Bailey CJ et al. Lancet. 2010;375: Strojek K et al. Diabetes Obes Metab. 2011;13: Stenlof K et al. Diabetes Obes Metab. 2013;15: Rosenstock J et al. Diabetes Care. 2012;35: Schernthaner G et al. Diabetes Care. 2013;36:

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36 Demonstration of the cascade of clinical events and metabolic changes that contribute sequentially to progressive clinical deterioration and development of full-blown episodes of eudka. Julio Rosenstock, and Ele Ferrannini Dia Care 2015;38: by American Diabetes Association

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38

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42 EMPA-REG CV death, MI and stroke Patients with event/analysed Empagliflozin Placebo HR (95% CI) p-value 3-point MACE 490/ / (0.74, 0.99)* CV death 172/ / (0.49, 0.77) < Non-fatal MI 213/ / (0.70, 1.09) Non-fatal stroke 150/ / (0.92, 1.67) Favours empagliflozin Favours placebo Cox regression analysis. MACE, Major Adverse Cardiovascular Event; HR, hazard ratio; CV, cardiovascular; MI, myocardial infarction *95.02% CI 42

43 Number needed to treat (NNT) to prevent one death across landmark trials in patients with high CV risk Simvastatin 1 for 5.4 years Ramipril 2 for 5 years Empagliflozin for 3 years High CV risk 5% diabetes, 26% hypertension Pre-statin era High CV risk 38% diabetes, 46% hypertension Pre-ACEi/ARB era <29% statin T2DM with high CV risk 92% hypertension >80% ACEi/ARB >75% statin S investigator. Lancet 1994; 344: , 2. HOPE investigator N Engl J Med 2000;342:145-53, 43

44 Insulin

45 Decline in b Cell Function in UKPDS Rx:Insulin, metformin, sulfonylurea b-cell function (%) Years from diagnosis Dashed line shows extrapolation forward and backward from years 0 to 6 based on HOMA data from UKPDS. Lebovitz H. Diabetes Rev. 1999;7:

46 Insulin concentrations 1922 U U-10 and U U U U-100 adopted 1958 U-500 Reg Beef 1998 U-500 Reg Hum 2015 U-200 Lispro 2015 U-300 Glargine 2015 U-200 Degludec

47 New Basal Insulins

48 Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs Plasma insulin Breakfast Lunch Dinner Novolog, Humalog or Apidra Aspart, Lispro or Glulisine Aspart, Lispro or Glulisine Basal Insulin 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Time 8:00

49 Basal Insulin NPH Glargine: Lantus and Toujeo Detemir: Levemir Degludec: Tresiba

50 Insulin Glargine U-300

51 Glargine U-300

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53

54 Insulin Degludec

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56 Degludec MOA

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58 Degludec Titration

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61 New Basal Insulins Reduced Intrasubject Variability True 24 Hour Duration Reduced Nocturnal Hypoglycemia Reduced Injection Burden in T2DM

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63

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65 Continuous Glucose Monitoring (CGM)

66 The First Step to An Artificial Pancreas: Minimed 530G

67 Continuous Glucose Monitor Sensor

68 Where is the ball going?

69 Hypoglycemia Unawareness with Freddie, no reaction occurred after a blood sugar of 60 mg/dl and with Alice S., none occurred when the blood sugar was as low as 40 Dangerous hypoglycemia may occur without warning symptoms. Joslin, E 1924

70 Case #1: Question What do you think this patient s sensor report will look like with A1C of 7.2%?

71 The person with diabetes who knows the most lives the longest Elliot Joslin

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