Best Drugs Following Metformin. Jack L. Leahy, M.D. Endocrinology, Diabetes and Metabolism University of Vermont Medical Center

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1 Best Drugs Following Metformin Jack L. Leahy, M.D. Endocrinology, Diabetes and Metabolism University of Vermont Medical Center

2 Disclosures Honoraria for advisory boards from Janssen, Merck, Novo-Nordisk, Sanofi, Valeritas. Completed grant support: - National Institutes of Health - American Diabetes Association - Juvenile Diabetes Research Foundation - Takeda pharmaceuticals

3 Case: Irene 43-year-old woman presents to discuss her diabetes. I ve had diabetes for 3 years. I take my metformin exactly as prescribed. And I eat fairly healthy, and walk my dog every day. I m really frustrated my weight is up 6 lbs this year, and my BG is still too high. I need help. I m afraid I m just like my mother, and she died at 55 of a heart attack. PMH hypertension, hyperlipidemia, and diabetes. Meds: Losartan 100 mg, Atorvastatin 20 mg, Metformin XR 2000 mg daily. FBG mg/dl, HS mg/dl BMI: 32 kg/m 2 Waist: 39 inches BP: 132/80 mm Hg (bilaterally) A1C: 8.5% egfr: >60 ml/min/ 1.73 m 2 Cholesterol: 170 mg/dl HDL-C: 36 mg/dl TG: 206 mg/dl LDL-C: 93 mg/dl TSH: 1.5 mg/dl U MA ratio: 7 mg/g Cr

4 Drug Availability for Diabetes 1950 to present Number of unique classes 12 10/ Insulin DPP-4 Inhibitors GLP-1 Receptor Agonists Thiazolidinediones Metformin SUs - Glipizide, Glyburide, Glimepiride Pramlintide Bromocriptine/ Colesevelam Repaglinide, Nateglinide α-glucosidase inhibitors SGLT-2 Inhibitors

5 Inzucchi S, et al. Diabetes Care 2015;38:

6

7 Goals for Today s Presentation Discuss pharmacologic options for treating type 2 DM: - Case of metformin failure. - New findings for key benefits or problems. - Hot topics.

8 Metformin - Summary Mechanism of action debated. Activate AMP-kinase. Inhibit mitochondrial glycerol phosphate. Reduce gluconeogenesis and hepatic glucose production. Modest insulin sensitizer. Inexpensive. Side effects: Diarrhea and GI distress. Not induce hypoglycemia or weight gain; rare lactic acidosis. Hot topics: Cardioprotective. Lowered incidence of cancers.

9 Metformin Renal Safety Update April 8, 2016 Before starting metformin, obtain the patient s egfr egfr < 30: metformin is contraindicated egfr 30-45: starting metformin is not recommended For patients taking metformin Check egfr at least annually, more frequently in patients at increased risk for developing renal impairment If egfr falls below 45, assess benefits and risks of continuing treatment If egfr falls below 30, discontinue metformin Discontinue metformin in patients With egfr between 30 and 60 at the time of or before an iodinated contrast imaging procedure Who will be administered intra-arterial iodinated contrast reevaluate egfr 48 hours after the procedure and restart metformin if renal function is stable With a history of liver disease, alcoholism, or heart failure edicalproducts/ucm htm?source=govdelivery&utm_medium= &utm_source=govdelivery.

10 Drug Availability for Diabetes 1950 to present Number of unique classes 12 10/ Insulin DPP-4 Inhibitors GLP-1 Receptor Agonists Thiazolidinediones Metformin SUs - Glipizide, Glyburide, Glimepiride Pramlintide Bromocriptine/ Colesevelam Repaglinide, Nateglinide α-glucosidase inhibitors SGLT-2 Inhibitors

11 Sulfonylurea - Summary Closes K-ATP channel in ß-cells leading to depolarization that stimulates insulin secretion. Bypasses cellular machinery that confers ß-cell glucose regulation of insulin secretion. Inexpensive. Many members glyburide, glipizide, glimepiride. Side effects: Weight gain. Risk of hypoglycemia glyburide biggest risk of hypos. Poor durability of therapy. Cardiovascular risk still debated. Use falling around the world because of newer (more expensive) secretagogues.

12 Thiazolidinediones (TZDs) Summary Acts on PPAR-gamma signaling pathway. Major effect in adipocytes more favorable adipokine profile (enhance insulin sensitivity) and promote adipogenesis (weight gain). Modest expense. Members pioglitazone, rosiglitazone. Side effects: Weight gain. Enhanced vascular volume edema and CHF risk. Increased rate of long-bone fracture in postmenopausal women. + Absence of hypoglycemia Hot topics: - Bladder cancer risk with Pioglitazone recent data says none - Increased CV risk with rosiglitazone recent data says none - Enhanced survival after stroke IRIS study

13 Kernan WN et al. N Engl J Med 2016;374:

14 Pioglitazone after TIA or Ischemic Stroke in Nondiabetic Insulin Resistant Subjects ISIS Study Lower risk of stroke and MI, not death. Higher incidence of weight gain, edema, and bone fracture Kernan WN et al. N Engl J Med 2016;374:

15 Drug Availability for Diabetes 1950 to present Number of unique classes 12 10/ Insulin DPP-4 Inhibitors GLP-1 Receptor Agonists Thiazolidinediones Metformin SUs - Glipizide, Glyburide, Glimepiride Pramlintide Bromocriptine/ Colesevelam Repaglinide, Nateglinide α-glucosidase inhibitors SGLT-2 Inhibitors

16 Basal Insulin Therapy Nondiabetic Type 2 diabetes mg/dl Polonsky KS et al. N Engl J Med 1988;318: :00 10:00 14:00 18:00 22:00 2:00 6:00 B L D Time B = breakfast; L = lunch; D = dinner.

17 Approved Insulins: United States Basal Prandial Premixed/ Biphasic Human Insulins Analogue Insulins Human Insulins Analogue Insulins Human Insulins Analogue Insulins U-100 NPH U-100 detemir U-100 RHI U-100 aspart U-100 RHI 70/30 U-100 ASP 70/30 U-100 glargine equivalent U-100 glargine U-300 glargine U-500 RHI Inhaled RHI U-100 glulisine U-100 lispro U-100 LIS 50/50 U-100 LIS 75/25 U-100 degludec U-200 lispro a U-100 DEG/ASP 70/30 U-200 degludec

18 Greater Likelihood Achieving HbA 1c <7% With Lower Baseline Pooled analysis 2193 patients 24 weeks titrated Glargine added to OAD 75 % of patients attaining < 7% HbA 1c < Baseline HbA 1c Riddle MC, et al. Diabetes Obes Metab 15: , 2013.

19 HbA 1c Reduction With Glargine Versus Baseline Oral Agents in Type 2 Diabetes /1 OAD 2 OADs MET only SU only MET + SU Mean HbA 1c at baseline HbA 1c 11 trials 2171 subjects p = p = * Fonseca V, Leahy JL et al. Diabetes Obes Metab 2011;13: Pooled analysis * p = vs all taking SU Mean HbA 1c at 24 weeks HbA 1c <7% (% patients)

20 Hypoglycemia and Weight with Glargine By Baseline Oral Agents Hypoglycemia Weight Change p = p = Confirmed hypoglycemia (% pts with BG < 50 mg/dl) Change in body weight (kg) p = p = /1 OAD 2 OAD Met only SU only MET + SU 0/1 OAD 2 OAD Met only SU only MET + SU Fonseca V, Leahy JL et al. Diabetes Obes Metab 2011;13:

21 Drug Availability for Diabetes 1950 to present Number of unique classes 12 10/ Insulin DPP-4 Inhibitors GLP-1 Receptor Agonists Thiazolidinediones Metformin SUs - Glipizide, Glyburide, Glimepiride Pramlintide Bromocriptine/ Colesevelam Repaglinide, Nateglinide α-glucosidase inhibitors SGLT-2 Inhibitors

22 Incretin Biology Incretins are gut-derived hormones: Secreted in response to nutrients, that potentiate insulin secretion and suppress glucagon secretion. Act in a glucose-dependent fashion. They are the signal between food ingestion and postmeal glucose and lipid control. Two predominant incretins: Glucagon-like peptide-1 (GLP-1) Glucose-dependent insulinotropic peptide (GIP) Rapidly inactivated by dipeptidyl peptidase 4 (DPP-4). Holst JJ, et al. Diabetes. 2004;53(suppl 3):s197-s204; Meier JJ, et al. Diabetes Metab Res Rev. 2005;21:

23 Secretion and Metabolism of Incretin Hormones GLP-1 and GIP L-Cell K-Cell Proglucagon Capillary GLP-1 [7-37] GLP-1 [7-36NH 2 ] ProGIP GIP [1-42] Capillary GLP-1[7-36NH 2 ] ACTIVE DPP-4 GLP-1 [9-36NH 2 ] INACTIVE Dipeptidyl peptidase-4 (DPP-4) Ubiquitous, serine protease Cleaves N-terminal dipeptide Inactivates > 50% of GLP-1 in ~ 1 min > 50% of GIP in ~ 7 min GIP [1-42] ACTIVE DPP-4 GIP [3-42] INACTIVE

24 Defective Post-Meal Insulin and Glucagon in Type 2 Diabetes Patients Glucose mg/dl CHO meal NGT 150 Diabetes Insulin µu/ml Glucagon pg/ml Time (min) Muller WA, et al. N Engl J Med 283: , 1970.

25 DPP-4 Inhibitors

26 Comparison of DPP-4 Inhibitors Dosage Sitagliptin Saxagliptin Linagliptin Alogliptin 25, 50, 100 mg once daily 2.5, 5.0 mg once daily 5 mg once daily 6.25, 12.5, 25 mg daily Half-life (t 1/2 ) 12.4 h 2.2 to 3.8 h > 113 h 21 h 24-h DPP-4 inhibition 80% 5 mg: 55% > 90% > 78% Elimination Dose adjustments for renal impairment Kidney (mostly unchanged) Liver and kidney active metabolite Liver, <5% renal Kidney (mostly unchanged) Yes Yes None Yes Drug interaction potential Low Strong CYP3A4/5 inhibitors Strong CYP3A4/5 inhibitors Low Golightly LK,et al. Clin Pharmacokinet. 2012;51:

27 DPP-4 Inhibitors A1C as Monotherapy or in Combination with Other Oral Agents Regimen Comparator Trial Duration (weeks) Baseline A1C, % Sitagliptin 100 mg PO QD A1C, % Comparator A1C, % MONO 1 PBO a MET 2 GLIM b Saxagliptin 10 mg PO QD MONO 3 PBO c MET 4 PBO d Linagliptin 5 mg PO QD MONO 5 PBO c MET 6 PBO c MET/SU 7 PBO c Aschner P, et al. Diabetes Care. 2006;29: ; 2. Arechavaleta R, et al. Diabetes Obes Metab. 2011;13: ; 3. Rosenstock J, et al. Curr Med Res Opin. 2009;25: ; 4. DeFronzo R, et al. Diabetes Care. 2009;32: ; 5. Del Prato S, et al. Diabetes Obes Metab. 2011;13: ; 6. Taskinen MR, et al. Diabetes Obes Metab. 2011;13:65-74; 7. Owens D, et al. Diabet Medic. In Press. a P < vs. PBO. b Between group differences = 0.07%. 95% CI (-0.03, -0.16). c P < vs. PBO. d P < vs. baseline.

28 Safety and Tolerability of Sitagliptin Pooled Analysis of 12 Clinical Trials Sitagliptin n = 3415 n (%) Williams-Herman DE, et al. BMC Endocr Disord. 2008;8:14. Nonexposed n = 2724 n (%) Clinical adverse experiences 3% in any group Between-Group Difference, % (95% CI) Nasopharyngitis 244 (7.1) 162 (5.9) 1.2 ( 0.1, 2.4) Bronchitis 135 (4.0) 83 (3.0) 0.9 ( 0.0, 1.8) Urinary tract infection 134 (3.9) 100 (3.7) 0.3 ( 0.7, 1.2) Back pain 142 (4.2) 108 (4.0) 0.2 ( 0.8, 1.2) Headache 169 (4.9) 129 (4.7) 0.2 ( 0.9, 1.3) Hypoglycemia 117 (3.4) 296 (10.9) 7.4 ( 8.8, 6.1) Diarrhea 170 (5.0) 144 (5.3) 0.3 ( 1.4, 0.8) Influenza 145 (4.2) 127 (4.7) 0.4 ( 1.5, 0.6) Upper respiratory tract infection 265 (7.8) 228 (8.4) 0.6 ( 2.0, 0.8) Arthralgia 113 (3.3) 92 (3.4) 0.1 ( 1.0, 0.8) Hypertension 110 (3.2) 89 (3.3) 0.0 ( 1.0, 0.8) Incidences of cardiac disorders similar between groups

29 Hypoglycemia Risk with DPP-4 Inhibitors is Higher with Sulfoylureas and Insulin 1. US FDA Gallwitz B. Diabetes Metab Syndr Obes. 2013;6:1-9. [Epub Jan 4]. 3. Park H, et al. Ann Pharmacother. 2012;46:

30 Risk of Pancreatitis or Pancreatic Cancer with Incretin Therapies Reports of pancreatitis in DPP-4i and GLP-1 RA -treated patients to the FDA Adverse Event Reporting System led to eventual black box warnings for incretin therapies. - Divergent findings from database analyses fold risk of pancreatitis in type 2 diabetes. - Controversial animal and human studies suggested a higher rate of pancreatic metaplasia and cancer with incretin therapies. FDA/EMA statement on pancreatic safety of incretin-based drugs:...assertions concerning a causal association between incretin-based drugs and pancreatitis or pancreatic cancer...are inconsistent with the current data...current knowledge is adequately reflected in the product information and labeling Incretin therapies should be avoided in patients with a history of pancreatitis. Egan AG et al. N Engl J Med 2014;370: ; Li L et al. BMJ 2014;348:g2366

31 When to Use DPP-4 Inhibitors Following metformin with A1c <7.5% - 8%. New diagnosis or after metformin with A1c <7.5%-8% versus SU. New diagnosis with high A1c (>8%) using COMBINATION DPP-4i and metformin.

32 Initial Combination Therapy With Sitagliptin Plus Metformin Study: A1C Results Week Placebo-Adjusted Results Mean A1C = 8.8% LSM A1C Change From Baseline, % n= Sitagliptin 100 mg qd Metformin 500 mg bid Metformin 1,000 mg bid Sitagliptin 50 mg + metformin 500 mg bid Sitagliptin 50 mg + metformin 1,000 mg bid 3.5 Goldstein B et al. Diabetes Care 30: , 2007

33 Combination Sitagliptin Plus Metformin: 24-week Body Weight and Incidence Hypoglycemia Sitagliptin 50 mg + metformin 1,000 mg bid Metformin 1,000 mg bid Sitagliptin 100 mg qd Sitagliptin 50 mg + metformin 500 mg bid Metformin 500 mg bid Placebo 1 0 Weight Change From Baseline, kg Hypoglycemia (%) Rates of Hypoglycemia in Combination With Sitagliptin Placebo Sita 100 MF 500 bid MF 1,000 bid Sita 50 + MF 500 bid Sita 50 + MF 1,000 bid Meta-analysis of Metformin-DPP4 inhibitor vs Metformin: A1c 0.67% lower at 1 year; weight no different; hypoglycemia and GI effects no different.

34 When to Use DPP-4 Inhibitors Following metformin with A1c <7.5% - 8%. New diagnosis or after metformin with A1c <7.5%-8% versus SU. New diagnosis with high A1c (>8%) using COMBINATION DPP-4i and metformin. Full range of renal dysfunction.

35 Sitagliptin Efficacy is Similar Regardless of Renal Function (1-year data) HbA 1c Reductions In 3 Active-Controlled Clinical Trials Normal Renal Function to Mild Renal Impairment Moderate-to-Severe Renal Impairment ESRD on Dialysis Change in HbA 1c From Baseline, % Change in HbA 1c From Baseline, % 52 weeks 54 weeks 54 weeks Change in HbA 1c From Baseline, % Baseline HbA 1c : 7.7% Baseline HbA 1c : 7.8% Baseline HbA 1c : 7.9% SU (glipizide) HbA 1c reduction: 0.7% SU (glipizide) HbA 1c reduction: 0.6% SU (glipizide) HbA 1c reduction: 0.9% Nauck MA et al. Diabetes Obes Metab. 2007;9: ; Arjona Ferreira JC et al. Diabetes Care. 2013;36: ; Arjona Ferreira JC et al. Am J Kidney Dis. 2013;61:

36 When to Use DPP-4 Inhibitors Following metformin with A1c <7.5% - 8%. New diagnosis or after metformin with A1c <7.5%-8% versus SU. New diagnosis with high A1c (>8%) using COMBINATION DPP-4i and metformin. Full range of renal dysfunction. Elderly.

37 When to Use DPP-4 Inhibitors Following metformin with A1c <7.5% - 8%. New diagnosis or after metformin with A1c <7.5%-8% versus SU. New diagnosis with high A1c (>8%) using COMBINATION DPP-4i and metformin. Full range of renal dysfunction. Elderly. Cardiac disease. - Savor Timi Trial (Saxagliptin) - EXAMINE Trial (Alogliptin) - TECOS Trial (Sitagliptin)

38 Saxagliptin TIMI Trial 16,492 type 2 DM patients high risk for CVD received saxagliptin versus placebo plus usual care for median 2.1 years. Hospitalization for heart failure Saxagliptin 3.5% Placebo 2.8% P=0.007 Scirica BM et al. New Engl J Med 2013;369:

39 Other DPP-4 Inhibitor CVD Outcome Trials Alogliptin EXAMINE trial: 5380 patients followed for median 18 months treated with alogliptin versus placebo added to usual therapy. No difference in incidence of major cardiac events. No difference hospitalization for heart failure (3.1% vs 2.9%). Sitagliptin TECOS trial: 14,671 patients followed for median 3 years treated with sitagliptin or placebo added to usual therapy. No difference in incidence of CVD outcomes, heart failure, or pancreatitis. FDA Safety announcement for heart failure Saxagliptin and Alogliptin. White WB et al. N Engl J Med. 2013;369: ; Zannad F et al. Lancet. 2015;385: ; Green JB et al. N Engl J Med. 2015;373:

40 DPP-4 Inhibitors - Summary Act through slowed degradation of the incretin hormones GIP and GLP-1. Efficacy: Moderate A1C improvement. Weight neutral. Cost: Very expensive. Safety: - No added hypoglycemia unless used with sulfonylurea. - No GI side effects. - Debate over increased risk of pancreatitis appears to be insignificant. Dosing adjustments for renal dysfunction EXCEPT linagliptin. No class or agent-specific CVD protection. Hot topics: Congestive heart failure risk with saxagliptin and alogliptin. FDA warning over unexplained severe arthritis validity not established.

41 GLP-1 Receptor Agonists

42 DPP-4 Inhibitors and GLP-1 RAs Increase GLP-1 Activity in Different Ways Active GLP-1 DPP-4 GLP-1 RAs act like GLP-1 but are not readily degraded by DPP-4 < 2 min DPP-4 inhibitors increase GLP-1 by preventing degradation Inactive GLP-1 Crossover study, 2-week segments (N = 61); EXN BID vs SITA. 1. Baggio L, Drucker D. Gastroenterology. 2007;132: DeFronzo RA, et al. Curr Med Res Opin. 2008;24:

43 Increased insulin Lowered glucagon Enhanced insulin sensitivity Slowed motility GLP-1 GIP Increased CV dynamics Satiety Anabolic

44 Properties of GLP-1 Receptor Agonists Versus DPP-4 Inhibitors GLP-1 R agonist DPP-4 inhibitor injectable oral ß-cell function Glucagon A1c reduction 1-2% 0.5-1% Weight 1-5 kg reduction neutral GI side effects Occasional None Hypoglycemia Only with SUs Only with SUs BP and lipids Martin JH et al. Intern Med J 2011;41:

45 The GLP-1 RA Class: Pharmacokinetic Properties GLP-1 RA Short-acting (<24 hours) Long-acting ( 24 hours) Exenatide BID Lixisenatide Daily Liraglutide Daily Exenatide Weekly Albiglutide Weekly Dulaglutide Weekly Semaglutide Weekly

46 A1C and Weight Effects of GLP-1 RAs Differ: Head-to-Head Trials EXN BID 10 mcg DULA 1.5 mg EXN QW 2.0 mg LIRA 1.8 mg ALBI 50 mg AWARD-1 1 DURATION-5 2 LEAD-6 3 HARMONY-7 4 DURATION-6 5 AWARD-6 Long-Acting vs Twice-Daily EXN BID Once-Weekly vs Once-Daily LIRA 1. Wysham C, et al. Diabetes Care. 2014;37: ; 2. Blevins T, et al. J Clin Endocrinol Metab. 2011;96: ; 3. Buse JB, et al. Lancet. 2009;374:39-47; 4. Pratley RE, et al. Lancet Diabetes Endocrinol. 2014;2: ; 5. Buse JB, et al. Lancet. 2013;381: ; 6. Dungan KM, et al. Lancet. 2014;384:

47 When to Use GLP-1 Receptor Agonists As monotherapy or added to other therapy (not DPP-4i) in virtually any patient with type 2 DM. First injectable head to head trials versus basal insulin.

48 Liraglutide vs Once-Daily Insulin Glargine 26-weeks. Baseline A1c 8.2% LIRA 1.8 mg once daily Insulin glargine LIRA GLAR Weight change (kg) P < 0.05 Major hypoglycemia (events/patient-year) Minor hypoglycemia (events/patient-year) Russell-Jones D et al. Diabetologia 2009;52:

49 Failing Oral Therapy: Efficacy of GLP-1 RAs Compared to Basal Insulin EXN BID ALBI LIRA EXN QW DULA GLAR DET 1,a 2,b 3,a 4,a,c 5,d Noninferior vs insulin Noninferior vs insulin P <.05 vs insulin Average weight change: GLP-1 RA -1.8 to -2.7 kg versus insulin +1.4 to +3.0 kg a 26 weeks, BL A1C 8.2% to 8.7%. b 52 weeks, BL A1C 8.3%, 82% on MET + SU background. c 70% on MET + SU background. d 52 weeks, BL A1C 8.1%. 1. Heine R, et al. Ann Intern Med. 2005;143: Pratley R, et al. ADA 73rd Scientific Sessions [abstract 54-LB]. 3. Russell-Jones D, et al. Diabetologia. 2009;52: Davies M, et al. Diabetes Care. 2013;36: Giorgino F, et al. Diabetes. 2014;63(suppl 1):A8

50 When to Use GLP-1 Receptor Agonists As monotherapy or added to other therapy (not DPP-4i) in virtually any patient with type 2 DM. First injectable head to head trials versus basal insulin. - Combination basal insulin + GLP-1 RA agent.

51 Co-formulation of Basal Insulin and GLP-1 RA 26 week open label comparison of fixed dose insulin degludec + Liraglutide (n=834) to insulin degludec (414) or Liraglutide (415). Patients: on metformin ± pioglitazone, A1c 8.3% IDegLira Degludec Liraglutide Final A1c Nausea Weight 6.4% Noninferior Degludec Superior to Liraglutide 6.9% 7.0% 8.8% 3.6% 19.7% -0.5 kg 1.6 kg -3.0 kg Gough SC, et al. Lancet Diabetes Endocrinol 2014;2:

52 When to Use GLP-1 Receptor Agonists As monotherapy or added to other therapy (not DPP-4i) in virtually any patient with type 2 DM. First injectable head to head trials versus basal insulin. - Combination basal insulin + GLP-1 RA agent. Addition to basal insulin rather than prandial insulin.

53 GLP-1 RA versus Prandial insulin Added to Basal Insulin LIRA QD 1,a ASP QD 1,a EXN BID 2,b LIS TID 2,3,b,c ALBI QW 3,c P =.0024 Noninferior Noninferior Outcome LIRA vs ASP 1 EXN BID vs LIS 2 ALBI vs LIS 3 Δ Weight, kg 2.8 d d -0.7 d 0.8 Hypo, EPY e 1.0 d Nausea, % LIRA > ASP, first 2 wk a Added to DEG (26 wk, N = 177); DEG is not approved by the US FDA. b Added to GLAR (30 wk, N = 637). c Added to GLAR (26 wk, N = 566). d P <.05 between groups. e Rates of severe hypoglycemia were low across groups. 1. Mathieu C, et al. Diabetes Obes Metab. 2014;16: Diamant M, et al. Diabetes Care. 2014;37: Rosenstock J, et al. Diabetes Care. 2014;37:

54 When to Use GLP-1 Receptor Agonists As monotherapy or added to other therapy (not DPP-4i) in virtually any patient with type 2 DM. First injectable head to head trials versus basal insulin. - Combination basal insulin + GLP-1 RA agent. Addition to basal insulin rather than prandial insulin. Cardiac disease: - ELIXA trial (Lixisenatide). - LEADER (Liraglutide).

55 Liraglutide LEADER Trial 9,340 type 2 DM patients high risk for CVD received Liraglutide versus placebo plus usual care for median 3.8 years. Primary CV Outcome Death from CV Causes Marso SP et al. New Engl J Med 2016;375:

56 GLP-1 Receptor Agonists - Summary Activation of GLP-1 receptors - insulin secretagogue and inhibit glucagon in a glucose dependent fashion Cost very expensive. Efficacy: Potent lowering of A1c superior to other diabetes therapies, and equivalent to basal insulin. Frequent weight loss, and CVD risk factor benefit. - Superior clinical effects with long acting agents liraglutide (daily), and dulaglutide and exenatide (weekly). Safety: GI side effect nausea/vomiting/diarrhea usually transient. No added hypoglycemia unless used with sulfonylurea. Pancreatic safety appears without toxicity. CVD protection with Liraglutide.

57 Drug Availability for Diabetes 1950 to present Number of unique classes 12 10/ Insulin DPP-4 Inhibitors GLP-1 Receptor Agonists Thiazolidinediones Metformin SUs - Glipizide, Glyburide, Glimepiride Pramlintide Bromocriptine/ Colesevelam Repaglinide, Nateglinide α-glucosidase inhibitors SGLT-2 Inhibitors

58 SGLT2 Inhibitors: Mechanism of Action Glucose Glucose Transporters in the Renal Proximal Tubule S1 segment of proximal tubule 90% Reabsorption 10% Distal S2/S3 segment of proximal tubule SGLT2 SGLT1 Collecting duct Urinary excretion SGLT2 reabsorbs glucose ( 90%) from glomerular filtrate Returned to circulation Normally no glucose in urine As BG increases, SGLT2 capacity is exceeded and glucose is excreted in urine Normal threshold 200 mg/dl Threshold in T2DM 240 mg/dl SGLT2 inhibitors lower threshold for urinary excretion Glucose is spilled into urine at lower BG level Less glucose is returned to circulation Bays H. Diabetes Ther. 2013;4: Chao E, Henry R. Nature Rev Drug Discov. 2010;9: DeFronzo RA, et al. Diabetes Care. 2013;36:

59 Approved SGLT2 Inhibitors in U.S. Dapagliflozin Canagliflozin Empagliflozin Farxiga Invokana Jardiance Tablet 5, 10 mg 100, 300 mg 10, 25 mg Bioavailability >60 T1/ Metabolism Glucuronidation Glucuronidation Glucuronidation Elimination Urine, inactive metabolites Urine and feces Urine and Feces Drug Interactions Not clinically relevant Not clinically relevant Not clinically relevant GFR guidelines Not use if GFR <60 cc/min Not use if GFR <45 cc/min Not use if GFR <45 cc/min Scheen AJ. Drugs 2015;75:33-59.

60 SGLTi vs SU in Metformin Treatment Failure 52 weeks: Baseline A1c 7.7% to 7.9% CANA Glim DAPA Glip EMPA Glim Agent Δ Weight, kg Hypoglycemia, % SGLT SU SGLT SU CANA (300 mg) DAPA (10 mg) EMPA (25 mg) P< All SGLT2i values vs SU comparator Cefalu W, et al. Lancet 2013;382: ; Nauck M, et al. Diabetes Care 2011;34: ; Ridderstråle M, et al. Lancet Diabetes Endocrinol 2014;2(9):

61 SGLT2 Inhibitor Novel Safety Issues Postmarketing reports of serious UTIs urosepsis and/or pylenephritis requiring hospitalization. - Counsel patients to contact HCP if experience UTI symptoms. Euglycemic ketoacidosis: Most common in type 1 DM lowering of insulin doses during metabolic stress (URI, gastroenteritis, etc.). Measure of urinary ketones without hyperglycemia. nausea/vomiting. Discontinue SGLT2i, and treat usual way. Consider discontinue SGLT2i as a preventative measure in likely situations. Patients should avoid excess alcohol, and very low calorie ketogenic diets. Discontinue SGLTi 24 hours before surgery, procedures, etc. Increased bone fracture risk with Canagliflozin: Major contributor falls from hypotension and volume depletion. Modest reduction in BMD due in part to weight loss.

62 When to Use SGLT2 Inhibitors As monotherapy when metformin contraindicated or not tolerated. Following metformin with A1c <7.5% - 8%. As part of dual or triple OHA therapy: - Patients desiring weight loss. Added to basal insulin therapy.

63 When to Use SGLT2 Inhibitors As monotherapy when metformin contraindicated or not tolerated. Following metformin with A1c <7.5% - 8%. As part of dual or triple OHA therapy - Patients desiring weight loss. Added to basal insulin therapy. Cardiac disease. - EMPA Reg Trial (Empagliflozin)

64 Empagliflozin and Cardiac Outcomes in Type 2 Diabetes EMPA REG Trial 7020 patients treated with 2 doses of empagliflozin or placebo for a median 3.1 years. Primary outcome composite of death from CVD, nonfatal MI, or nonfatal stroke. No difference in incidence of stroke or nonfatal MI. With empagliflozin: - 38% reduction CVD death. - 35% reduction in hospitalization for heart failure. - 32% reduction death from any cause % reduction progression of renal disease and clinically relevant renal events Zinman B et al. N Engl J Med. 2015;373: ; Wanner C, et al. N Engl J Med. 2016;375:

65 SGLT2 Inhibitor - Summary Oral canaglflozin, dapagliflozin, empagliflozin. Reduced efficiency with renal dysfunction: CANA GFR cc/min 100 mg, not use <45 cc/min. DAPA not use if GFR <60 cc/min. EMPA not use if GFR <45 cc/min Cost very expensive. Efficacy: A1c lowering <1.0%. Weight loss (variable). Systolic and diastolic BP reduction (3-6 mm Hg). Safety: Low risk of hypoglycemia insulin independent. Genital infections and UTIs prior history of vaginitis. Potentiation of dehydration/hypotension.

66 Case: Irene 43-year-old woman presents to discuss her diabetes. I ve had diabetes for 3 years. I take my metformin exactly as prescribed. And I eat fairly healthy, and walk my dog every day. I m really frustrated my weight is up 6 lbs this year, and my BG is still too high. I need help. I m afraid I m just like my mother, and she died at 55 of a heart attack. PMH hypertension, hyperlipidemia, and diabetes. Meds: Losartan 100 mg, Atorvastatin 20 mg, Metformin XR 2000 mg daily. FBG mg/dl, HS mg/dl BMI: 32 kg/m 2 Waist: 39 inches BP: 132/80 mm Hg (bilaterally) A1C: 8.5% egfr: >60 ml/min/ 1.73 m 2 Cholesterol: 170 mg/dl HDL-C: 36 mg/dl TG: 206 mg/dl LDL-C: 93 mg/dl TSH: 1.5 mg/dl U MA ratio: 7 mg/g Cr

67 Case: Irene 43-year-old woman presents to discuss her diabetes. I ve had diabetes for 3 years. I take my metformin exactly as prescribed. And I eat fairly healthy, and walk my dog every day. I m really frustrated my weight is up 6 lbs this year, and my BG is still too high. I need help. I m afraid I m just like my mother, and she died at 55 of a heart attack. PMH hypertension, hyperlipidemia, and diabetes. Meds: Losartan 100 mg, Atorvastatin 20 mg, Metformin XR 2000 mg daily. FBG mg/dl, HS mg/dl BMI: 32 kg/m 2 Waist: 39 inches BP: 132/80 mm Hg (bilaterally) A1C: 8.5% egfr: >60 ml/min/ 1.73 m 2 Cholesterol: 170 mg/dl HDL-C: 36 mg/dl TG: 206 mg/dl LDL-C: 93 mg/dl TSH: 1.5 mg/dl U MA ratio: 7 mg/g Cr

68 Relative A1c Lowering and Risk of Hypoglycemia Agent Efficacy ( A1C) Hypoglycemia Sulfonylureas 0.85% HIGH Thiazolidinediones 0.42% LOW α-glucosidase inhibitors 0.61% LOW DPP-4 inhibitors 0.5%-0.8% LOW SGLT2 inhibitor % LOW GLP-1 RAs 1.0%-1.9% LOW Insulin unlimited HIGH Monami M et al. Diabetes Res Clin Pract. 2008;79: ; Rosenstock J et al. Diabetes Care. 2012;35: ; Musso G et al. Ann Med. 2012;44: ; Karagiannis T et al. BMJ. 2012;344:e1369. Esposito K etal. Curr Med Res Opin. 2011;27:

69 Relative Weight Effects of DM Therapies Significant Weight Gain Weight Neutral Weight Loss Modest Modest Pioglitazone SUs Glyburide Glipizide Insulin SUs Glimepiride Glipizide XL Repaglinide Nateglinide Insulin Metformin DPP-4 Inhibitors α-glucosidase Inhibitors Colesevelam Bromocriptine GLP-1 Receptor Analogs SGLT-2 Inhibitors Pramlintide Based on: Mitri J, Hamdy O. Expert Opin Drug Safety 2009;8:

70 Agent Efficiency A1c <7% Weight Loss BP and lipid benefits CVD protection Common side effects Sulfonylurea Hypoglycemia, weight gain TZD ± DPP4i ± ± Weight gain, edema GLP-1 RA GI SGLT2i Vaginitis, UTI Basal insulin Hypoglycemia, weight gain

71 Case: Irene Jointly decided to add in GLP-1 RA therapy started on 0.75 mg Dulaglutide weekly. Continued her metformin. Focused on lifestyle habits referred to a dietician for weight management strategies. Testing her BG twice daily fasting alternating with presupper and prebedtime. Follow up by phone every couple of weeks, and reseen in clinic 2 months later.

72 Jointly decided to add in GLP-1 RA therapy started on 0.75 mg Dulaglutide weekly. Continued her metformin. Focused on lifestyle habits referred to a dietician for weight management strategies. She started testing her BG twice daily fasting alternating with presupper and prebedtime. Follow up by phone every couple of weeks, and reseen in clinic 2 months later.

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