CANA DAPA EMPA. Change in Baseline Body Weight (kg) *Doses evaluated in studies cited: CANA=100 or 300 mg, DAPA=5 or 10 mg, EMPA=10 or 25 mg.

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1 CANA DAPA EMPA Change in Baseline Body Weight (kg) PBO SGLT2 inhibitor (low dose)* SGLT2 inhibitor (high dose)* *Doses evaluated in studies cited: CANA=100 or 300 mg, DAPA=5 or 10 mg, EMPA=10 or 25 mg. 41

2 ! SGLT2 inhibition is associated with reductions in BP presumably due to chronic osmotic diuresis caused by glycosuria Decreases in systolic BP have consistently been observed with CANA, DAPA, and EMPA treatment (up to 5 mm Hg with DAPA) Reports of changes in diastolic BP have been smaller and inconsistent! May afford vascular protection, particularly against the risks of stroke and heart failure. These benefits not yet demonstrated in clinical trials Foote C, et al. Diab Vasc Dis Res. 2012;9(2): Haring HU, et al. Diabetes Care. 2014;37(6):

3 ! Observed effects on the serum lipid profile have been modest Small increases in both HDL-C and LDL-C cholesterol Observed changes in triglyceride levels have been variable Foote C, et al. Diab Vasc Dis Res. 2012;9(2):

4 Baseline (%) LS Mean Change (±SE) in HbA 1c From Baseline (%) % (95% CI: -0.55, -0.35) -0.65% (95% CI: -0.74, -0.55) Placebo CANA 100 mg CANA 300 mg Baseline HbA1c % (95% CI: -1.07, -0.75) % (95% CI: -1.24, -0.91) % (95% CI: -1.54, -0.97) % (95% CI: -1.77, -1.20) LS, least squares; SE, standard error; CI, confidence interval. Wilding JP, et al. J Diabetes Complications. 2015;29(3):

5 N Baseline (%) T2DM Duration <5 Years T2DM Duration 5-<10 Years T2DM Duration 10 Years LS Mean Change (±SE) in HbA 1c From Baseline (%) % (95% CI: -0.84, -0.56) -0.96% (95% CI: -1.10, -0.82) Placebo CANA 100 mg CANA 300 mg % (95% CI: -0.90, -0.59) -0.91% (95% CI: -1.06, -0.75) % (95% CI: -0.89, -0.58) -0.85% (95% CI: -1.00, -0.70) Wilding JP, et al. J Diabetes Complications. 2015;29(3):

6 Mean baseline 7.99% 8.04% 7.99% 8.05% 8.05% Change From Baseline HbA 1c (%) (64 mmol/mol) (64 mmol/mol) (64 mmol/mol) (64 mmol/mol) (64 mmol/mol) -1.17% -1.22% (95% CI: , 0.07) P= % (95% CI: , 0.43) P< (95% CI: , 0.48) P< % (95% CI: , 0.48) P< % Change From Baseline HbA 1c (mmol/mol) EMPA 25 mg/linagliptin 5 mg (n=134) EMPA 10 mg/linagliptin 5 mg (n=135) EMPA 25 mg (n=133) EMPA 10 mg (n=132) Linagliptin 5 mg (n=133) Reductions from baseline HbA 1c with EMPA/linagliptin were greater vs linagliptin and EMPA 10 mg, but not vs EMPA 25 mg. Lewin A, et al. Diabetes Care. 2015;38(3):

7 Mean (SE) HbA 1c, % SAXA+DAPA+MET SAXA+MET DAPA+MET Weeks SAXA, saxagliptin. Rosenstock J, et al. Diabetes Care. 2015;38(3):

8 Glucose INS Glucagon n n n Baseline, mg/dl Baseline, µu/ml Baseline, pg/ml Adjusted Mean (95% CI) Change From Baseline in Glucose AUC, mg/dl Adjusted Mean (95% CI) Change From Baseline in INS AUC, µu/ml Adjusted Mean (95% CI) Change From Baseline in Glucagon AUC, pg/ml mg/dl (-6285, -4977) µu/ml (-2520, -1044) pg/ml (-1176, 1429) mg/dl (-3356, -30) SAXA+DAPA+MET SAXA+MET DAPA+MET -102 µu/ml (-841, 638) pg/ml (-3931, -1339) Addition of SAXA and DAPA to MET reduced glucose without increasing INS or glucagon. AUC, area under the curve. Hansen L, et al. Endocr Pract. 2014;20(11):

9 Long-term Treatment with SGLT2 Inhibitors

10 INS Dose (u/day) HbA 1c (%) INS Dose HbA1c ± ± ± % ± 0.07% (60 ± 0.8 mmol/mol) 7.24% ± 0.07% (58 ± 0.8 mmol/mol) 7.08% ± 0.07% (54 ± 0.8 mmol/mol) MDI INS + placebo MDI INS + EMPA 10 mg MDI INS + EMPA 25 mg 52 weeks of EMPA treatment was associated with reduced A1c levels, INS requirements, and body weight in obese patients with T2DM. MDI, multiple daily injection. Week Rosenstock J, et al. Diabetes Care. 2014;37(7):

11 Weight Systolic BP Baseline (kg) LS Mean % Change (±SE) In Body Weight From Baseline LS Mean % Change (±SE) in Systolic BP From Baseline (mm Hg) Time Point (Weeks) *55-80 years of age. Bode B, et al. Diabetes Obes Metab. 2015;17(3): Baseline (mm Hg) Time Point (Weeks) LS mean % change -0.6% (-0.6 kg) -3.0% (-2.7 kg) -3.8% (-3.5 kg) LS mean % change 4.5 mm Hg -1.2 mm Hg -3.0 mm Hg -2.3% (95% CI: -3.1, -1.6) (-2.1 kg) -3.2% (95% CI: -4.0, -2.4) (-2.9 kg) -5.8 mm Hg (95% CI: -8.0, -3.5) -7.5 mm Hg (95% CI: -9.8, -5.2) Placebo CANA 100 mg CANA 300 mg 51

12 HbA 1c (%) Adjusted Mean Change From Baseline Efficacy endpoint evaluation period Time (Weeks) Placebo; HbA 1c baseline 8.0% DAPA; HbA 1c baseline 8.0% DAPA added on to background therapy improved A1c levels without increasing hypoglycemic risk, promoted weight loss, and was well tolerated in patients >65 years old. Leiter LA, et al. J Am Geriatr Soc. 2014;62(7):

13 Safety and Tolerability

14 ! Most common adverse events (AE): Genital mycotic infection (GMIs) Lower urinary tract infection (UTIs) Usually mild in intensity and respond to standard over-the-counter treatment! More often observed in women than in men Risk higher for women prone to fungal infection and uncircumcised men! Meta-analysis of 8 studies found GMIs and UTIs to be more common with SGLT2 inhibitor treatment* vs other antidiabetics AE Odds Ratio 95% CI UTI , 1.90 GMI , 7.45 *CANA or DAPA. Nauck MA. Drug Des Devel Ther. 2014;8: Vasilakou D, et al. Ann Intern Med. 2013;159(4):

15 ! Patients with chronic kidney disease Increased risk of SGLT2 inhibitor-associated hypoglycemia when combined with other background therapies Decreased or lack of efficacy Particularly susceptible to nephrotoxic effects of SGLT2 inhibitors! Patients with history of bladder cancer Possible increased risk of bladder cancer was observed in DAPA trials DAPA should not be used in patients with history of bladder cancer Yale JF, et al. Diabetes Obes Metab. 2013;15(5): Mikhail N. World J Diabetes. 2014;5(6): Peene B, et al. Ther Adv Endocrinol Metab. 2014;5(5):

16 Parameter Response HbA1c! FPG! PPG! Body weight! BP! LDL-C " HDL-C " Triglycerides "! or #$ Genital infections " Vivian EM. Drugs Context. 2014;3: Mikhail N. World J Diabetes. 2014;5(6): UTI " or #$ 56

17 ! Prompt diagnosis of diabetes and achievement of glycemic control is necessary to reduce the risk of microvascular and possibly cardiovascular complications! T2DM management requires individualized treatment, patient education, and support to empower patients to manage their disease! SGLT2 inhibitors: Target hyperglycemia through prevention of renal glucose reabsorption Are effective alone and with oral therapies or INS Are associated with a low risk for hypoglycemia and other side effects 57

18 Thank You!

19 Back-up Slides

20 ! Physical inactivity! Increased caloric intake (obesity)! First-degree relative with diabetes! Race/ethnicity! Delivery of a baby weighing >9 lb or diagnosed with gestational diabetes mellitus! Clinical conditions associated with insulin resistance (eg, severe obesity, metabolic syndrome, acanthosis nigricans)! Polycystic ovarian syndrome American Diabetes Association. Diabetes Care. 2014;37(suppl 1):S14-S80. 60

21 ! A1c >5.7%, IGT, or IFG on previous testing! Hypertension (>140/90 mm Hg or on therapy for hypertension)! HDL cholesterol level 35 mg/dl (0.90 mmol/l) and/or a triglyceride level 250 mg/dl (2.82 mmol/l)! History of cardiovascular disease American Diabetes Association. Diabetes Care. 2014;37(suppl 1):S14-S80. 61

22 ! Liver Excess glucose production in the liver is the primary cause of fasting hyperglycemia Suppression of hepatic glucose production in response to insulin is impaired with T2DM Hepatic glucose production in T2DM individuals fails to suppress normally following a meal! Muscle Glucose uptake after a meal is decreased, resulting in postprandial hyperglycemia DeFronzo RA, Ferrannini E. Diabetes Metab Rev. 1987;3: Magnusson I, et al. J Clin Invest. 1992;90: DeFronzo RA. Diabetes. 2009;58:

23 ! Resistance to the suppressive effect of insulin on lipolysis results in chronically elevated plasma FFA Elevated plasma FFA stimulates hepatic gluconeogenesis, causes hepatic/muscle insulin resistance, and decreases insulin secretion! Excessive production of adipocytokines that are insulin resistance-inducing, inflammatory, and atheroscleroticprovoking! Inadequate production of adipocytokines that are insulinsensitizing (eg, adiponectin)! Decrease insulin-stimulated glucose uptake DeFronzo RA. Diabetes. 2009;58:

24 ! Impaired incretin response in T2DM Reduced insulin secretion in response to GIP and GLP-1 stimulation Decreased suppression of glucagon secretion by GLP-1, contributing to elevated plasma glucagon levels Impaired suppression of postprandial hepatic glucose production (due to reduced insulin secretion and enhanced glucagon secretion)! Defective response is not attributable to changes in GIP or GLP-1 levels, which varies across patients! Underlying mechanisms involve downregulation of GIP receptor expression and/or attenuation of receptor signaling GIP, gastric inhibitory polypeptide, also called glucose-dependent insulinotropic polypeptide; GLP-1, glucagon-like peptide-1. Campbell JE et al. Cell Metab. 2013;17(6): DeFronzo RA. Diabetes. 2009;58:

25 Prevention of Diabetes Onset: Early Intervention

26 Defronzo RA. Diabetes. 2009;58: ; Holman RR. Diabetes Res Clin Pract. 1998;40(suppl):S21-S25; U.K. Prospective Diabetes Study Group. Diabetes. 1995;44: ; Ramlo-Halsted BA, Edelman SV. Prim Care. 1999;26: ; Nathan DM. N Engl J Med. 2002;347:

27 ADA 2015 Guidelines. Diabetes Care 2015;38(S1):S

28 Study Groups Average Follow-up (Years) Incidence of Diabetes* Relative Risk Reduction (%) P Value Da Qing Control, diet, exercise, diet & exercise % (control vs diet); 46% (control vs exercise); 42% (control vs diet and exercise) all <.05 Finnish Diabetes Prevention Study Control, lifestyle % <.001 US DPP PBO, lifestyle % <.001 Indian DPP Control, lifestyle %.018 *per 100 person-years PBO, placebo. Reviewed in Kahn SE et al. Lancet. 2014;383(9922):

29 Study Groups Average Follow-up (Years) Incidence of Diabetes Relative Risk Reduction (%) P Value US DPP PBO, metformin % <.001 Indian DPP Control, metformin %.029 Nepi Antidiabetes Study PBO, glimepiride %.072 STOP-NIDDM PBO, acarbose %.0015 XENDOS PBO, orlistat %.0024 NAVIGATOR PBO, nateglinide % NS ORIGIN Control, insulin glargine %.006 TRIPOD PBO, troglitazone % <.01 US DPP PBO, troglitazone % <.001 DREAM PBO, rosiglitazone % <.001 ACT NOW PBO, pioglitazone % <.001 Reviewed in Kahn SE et al. Lancet. 2014;383(9922):

30 Study Groups Average Follow-up (Years) Incidence of Diabetes Relative Risk Reduction (%) P Value Indian DPP CANOE Control, lifestyle plus metformin PBO, lifestyle plus rosiglitazone % % <.001 Reviewed in Kahn SE et al. Lancet. 2014;383(9922):

31 Class Generic Severe A1c Dosing Injected Weight Hypoglycemia Reduction (times/day) or Oral Change R, Lispro, Aspart, Glulisine N Injected Y NPH, Glargine, Detemir N Injected Y Other Safety Concerns (beyond hypoglycemia and weight gain) Breast Cancer Glipizide ER, Glimepiride Y Oral Y CVD Repaglinide N Oral Y Nateglinide Y Oral Rare Metformin Y Oral N Neutral B12 deficiency, lactic acidosis Acarbose, Miglitol Y Oral N Neutral Pio-, rosi- glitazone Y Oral N CHF, Bone fx, Bladder Ca Pramlintide N Injected N Exenatide N Injected N ARF, Pancreatitis, PancCa Liraglutide N Injected N ARF, Pancreatitis, MTC, PancCa Exenatide QW, Dula- Albiglutide N 1.6* Every 7d Injected N ARF, Pancreatitis, MTC, PancCa Sita-, saxa-, lina-, allo- gliptin N Oral N Neutral Pancreatitis, PancCa Colesevelam N ~ Oral N Neutral Hypertriglyceridemia Bromocriptine QR N ~0.6 1 Oral N Neutral Various in PI Cana-, dapa- gliflozin N Oral N Formulation and dosing information taken from the current prescribing information for each respective therapy. Adapted from: Nathan DM, et al. Diabetes Care. 2009; 32: ; ADA. Diabetes Care. 2010;33:S11-S61; Buse J, et al. In: Williams Textbook of Endocrinology, 12 th ed Dehydration, Genital/urinary tract infections (UTI), Bladder Ca 71

32 Garber AJ, et al. Endocr Pract. 2013;19:

33 0 % Change in HbA 1c CANA 100 mg (-0.81%) CANA 300 mg (-1.11%) Time (weeks) % Change in Body Weight 2 4 CANA 100 mg (Mean change: -2.8 kg) CANA 300 mg (Mean change: -3.9 kg) 6 Stenlof K, et al. Curr Med Res Opin. 2014;30: Time (weeks) 73

34 CANA 100 mg CANA 300 mg Outcome Measure Difference versus placebo Systolic BP 3.7* 5.4* Diastolic BP Triglycerides (mg/dl) LDL-C (mg/dl) HDL-C (mg/dl) 6.8* 6.1 LDL-C/HDL-C Non HDL-C (mg/dl) *P<.001; P<.01. Stenlof K, et al. Diabetes Obes Metab. 2013;15:

35 Del Prato S et al. Diabetes Obes Metab

36 Potential Impact of SGLT2 Inhibition on the Pathology of T2DM

37 Two weeks of DAPA treatment was associated with increased C-Pep0 120/ G0 120 IR, suggesting an improvement in β-cell function *P <.05 vs baseline and vs placebo. Merovci A et al. J Clin Endocrinol Metab. 2015:jc

38 DAPA treatment has been associated with improved insulin sensitivity in addition to reductions in HbA1c and weight in patients with T2DM Merovci A et al. J Clin Invest. 2014;124(2): Mudaliar S et al. Diabetes Technol Ther. 2014;16(3):

39 *P <.05. Merovci A et al. J Clin Invest. 2014;124(2):

40 FPI, fasting plasma insulin; EOS, end of study. *P <.05, **P <.01. Merovci A et al. J Clin Invest. 2014;124(2):

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