FORXIGA Educational Slide Resource

1 732HQ12PM083 Date of preparation: October 2012

Introducing FORXIGA
FORXIGA, a first-in-class SGLT2 inhibitor, removes excess glucose via an insulin-independent mechanism of action and provides: Significant and sustained HbA1c reductions15 Additional benefits of weight loss15 and a reduction in blood pressure1,5 Low incidence of hypoglycaemia1 In one 10 mg tablet a day5* Add on for patients uncontrolled on metformin who need the additional benefit of weight loss and have normal or only mildly impaired renal function
*In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased up to 10 mg. 1. Bailey CJ, et al. Lancet 2010;375:222333; 2. Bailey CJ, et al. Diabetes 2011;60(Suppl. 1):988-P; 3. Nauck MA, et al. Diabetes Care 2011;34:201522; 4. Nauck MA, et al. Diabetes 2011;60(Suppl. 1):Poster 40-LB; 5. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

Overview
Current challenges in Type 2 diabetes The role of the kidney in Type 2 diabetes FORXIGA (dapagliflozin) Mechanism of action Efficacy and safety profile Dosing and administration

Approximately 53 million adults suffer from diabetes in Europe

Prevalence* of diabetes (2079 years) in Europe, 2011

8.1% of the adult population in Europe suffer from diabetes1 By 2030, the prevalence of diabetes in Europe is forecast to rise to 9.5% of the adult population1

*Comparative prevalence. 1. The International Diabetes Federation. Diabetes Atlas, 5th edition (2011). Available at: http://www.idf.org./diabetesatlas/5e/europe. Last accessed May 2012.

Despite advances in treatment, a significant proportion of patients with Type 2 diabetes still fail to reach target HbA1c levels
Percentage of patients not achieving glycaemic goals in Europe
CODE-2 study (19981999)1 Target HbA1c level: 6.5%
100

PANORAMA study (2009)2 Target HbA1c level: 7.0%

Patients not controlled (%)

31% 69%
Failed to reach target Achieved target

80

60

40

20

Nine EU UK countries (n=498) (n=5754)

France (n=750)

Germany Italy (n=793) (n=750)

Spain (n=743)

CODE-2, Cost of Diabetes in Europe - Type 2. 1. Liebl A, et al. Diabetologia 2002;45:S238; 2. De Pablos-Velasco P, et al. Diabetologia 2010;53(Suppl. 1):1012-P.

Diabetes and obesity are closely interlinked

Relationship between BMI and risk of Type 2 diabetes
100 Age-adjusted relative risk for Type 2 diabetes Normal weight 75
Women Men

Overweight

Obese

50

25

0
<23 <2323.9 <2424.9 <2526.9 <2728.9 <2930.9 <3132.9 <3334.9 35

BMI (kg/m2)
*Results are from two different studies. The first study is from a cohort of 27,983 US male health professionals, 4075 years of age in 1986 who completed biennial questionnaires sent out in 1986, 1988, 1990 and 1992 (follow-up: 19871922). The second study is from a cohort of 114,281 US female registered nurses, 3055 years of age in 1976 who completed questionnaires (follow-up: 19761990). BMI, body mass index. Adapted from: 1. Chan J, et al. Diabetes Care 1994;17:9619; 2. Colditz GA, et al. Ann Intern Med 1995;122:4816.

Controlling multiple parameters is essential for effective treatment of patients with Type 2 diabetes

HbA1c
Weight Blood pressure Lipids

Reductions in glycaemic control (HbA1c) and other parameters that are sustained over time can benefit the health of patients with Type 2 diabetes15

1. Stratton IM, et al. BMJ 2000;321:40512; 2. Pi-Sunyer FX. Postgrad Med 2009;121:94107; 3. Williamson DF, et al. Diabetes Care 2000;23:1499504; 4. Patel A, ADVANCE Collaborative Group. Lancet 2007;370:82940; 5. Pyrl K, et al. Diabetes Care 1997;20:61420.

The role of the kidney in Type 2 diabetes and SGLT2 inhibition

Normal glucose homeostasis1,2

Net balance ~0 g/day
Glucose input ~250 g/day: Dietary intake ~180 g/day Glucose production ~70 g/day Gluconeogenesis Glycogenolysis
The kidney filters circulating glucose

Glucose uptake ~250 g/day: Brain ~125 g/day Rest of the body ~125 g/day

The kidney reabsorbs and recirculates glucose

Glucose filtered ~180 g/day

Glucose reabsorbed ~180 g/day

1. Wright EM. Am J Physiol Renal Physiol 2001;280:F1018; 2. Gerich, JE. Diabetes Obes Metab 2000;2:34550.

Glucose handling in Type 2 diabetes1,2

Glucose input >280 g/day: Dietary intake >180 g/day Glucose production ~100 g/day Gluconeogenesis* Glycogenolysis
Average blood glucose concentration 150 mg/dL Kidney filters all circulating glucose

Glucose uptake >250 g/day: Brain ~125 g/day Rest of the body >125 g/day

Increased reabsorption and recirculation of glucose

Glucose filtered ~270 g/day

*Elevated glucose production in patients with Type 2 diabetes attributed to hepatic and renal gluconeogenesis.2 1. Gerich JE. Diabet Med 2010;27:13642; 2. Abdul-Ghani MA, DeFronzo RA. Endocr Pract 2008;14:78290.

Above the renal threshold for glucose (~200 mg/dL), glucose is excreted in the urine (glucosuria)

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Normal renal glucose handling13

Majority of glucose is reabsorbed by SGLT2 (90%)

Proximal tubule
SGLT2 Glucose

Glucose filtration
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Remaining glucose is reabsorbed by SGLT1 (10%)

Minimal to no glucose excretion

SGLT, sodium-glucose co-transporter. 1. Wright EM. Am J Physiol Renal Physiol 2001;280:F1018; 2. Lee YJ, et al. Kidney Int Suppl 2007;106:S2735; 3. Hummel CS, et al. Am J Physiol Cell Physiol 2011;300:C1421.

Existing and novel mechanisms to reduce hyperglycaemia in Type 2 diabetes14

Insulin-dependent mechanisms 1
Insulin action
Thiazolidinediones Metformin
Adipose tissue, muscle and liver

Insulin-independent mechanism
SGLT2 inhibition

Insulin release
Sulphonylureas GLP-1R agonists* DPP4 inhibitors* Meglitinides

Pancreas

Insulin replacement
Insulin

Glucose utilisation

Glucose excretion/caloric loss

*In addition to increasing insulin secretion, which is the major mechanism of action, GLP-1 agonists and DPP4 inhibitors also act to decrease glucagon secretion. DDP4, dipeptidyl peptidase-4; GLP-1R, glucagon-like peptide-1 receptor. 1. Washburn WN. J Med Chem 2009;52:178594; 2. Bailey CJ. Curr Diab Rep 2009;9:3607; 3. Srinivasan BT, et al. Postgrad Med J 2008;84:52431; 4. Rajesh R, et al. Int J Pharma Sci Res 2010;1:13947.

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FORXIGA: A novel insulin-independent approach to remove excess glucose13

Reduced glucose reabsorption FORXIGA
SGLT2

Proximal tubule

FORXIGA

SGLT2 Glucose

Glucose filtration

Increased urinary excretion of excess glucose (~70 g/day, corresponding to 280 kcal/day*)

FORXIGA selectively inhibits SGLT2 in the renal proximal tubule

*Increases urinary volume by only ~1 additional void/day (~375 mL/day) in a 12-week study of healthy subjects and patients with Type 2 diabetes.4 1. Wright EM. Am J Physiol Renal Physiol 2001;280:F1018; 2. Lee YJ, et al. Kidney Int Suppl 2007;106:S2735; 3. Hummel CS, et al. Am J Physiol Cell Physiol 2011;300:C1421; 4. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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The benefits of FORXIGAs unique mechanism of action

FORXIGAs inhibition of SGLT2 results in daily urinary excretion of excess glucose ~70 g, providing:1 Significant HbA1c reductions2,3 Additional benefits of weight loss and a reduction in blood pressure2 FORXIGA acts independently of insulin mechanisms2

Works regardless of -cell function

Complements insulin-dependent mechanisms

Low propensity for hypoglycaemia

1. List JF, et al. Diabetes Care 2009;32:6507; 2. Bailey CJ, et al. Lancet 2010;375:222333; 3. Bailey CJ, et al. Diabetes 2011;60(Suppl. 1):988-P.

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FORXIGA is indicated in adults with Type 2 diabetes to improve glycaemic control as...
Add-on combination therapy In combination with a monotherapy of metformin, a monotherapy of sulphonylureas or a treatment with insulin ( oral antidiabetic drugs) when these, together with diet and exercise, do not provide adequate glycaemic control Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance

The use of FORXIGA with pioglitazone is not recommended. FORXIGA has not been studied in combination with DPP4 inhibitors or GLP-1 analogues. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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FORXIGA clinical data

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FORXIGA: A Comprehensive Phase III clinical development programme with 40% of patients from Europe
Phase III N=5693 Monotherapy n=840 Monotherapy n=558 Low dose n=282 Add-on combination n=2369 Add-on to metformin n=546 Add-on to SU n=596 Add-on to pioglitazone* n=420 Add-on to insulin n=807 Comparator n=2050 Add-on to metformin compared with SU n=814 FORXIGA 5 mg combined with metformin XR n=598 FORXIGA 10 mg combined with metformin XR n=638 Special studies n=434 DXA body composition n=182 Moderate renal impairment n=252 Large CV outcomes trial planned as postmarketing commitment

*The use of FORXIGA with pioglitazone is not recommended; metformin extended release (XR) is not approved or available in all European countries; FORXIGA should not be used in patients with moderate to severe renal impairment (CrCl <60 mL/min or eGFR <60 mL/min/1.73 m2). CrCl, creatinine clearance; CV, cardiovascular; DXA, dual-energy X-ray absorptiometry; eGFR, estimated glomerular filtration rate; SU, sulphonylurea.

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FORXIGA: Significant reductions in HbA1c compared with placebo at the 24-week primary endpoint
FORXIGA 10 mg + metformin 24 weeks Placebo + metformin 0.30%
(n=134)

HbA1c change from baseline (mean adjusted for baseline values)

0.0 -0.2 -0.4 -0.6

0.84% -0.8 -1.0

(n=132)

0.54%
difference p<0.0001

Mean baseline HbA1c 7.92%

Mean baseline HbA1c 8.11%

Changes reported for Week 24 are adjusted for baseline values and are based on last observation carried forward (LOCF). A Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group, 24-week clinical study to evaluate the efficacy and safety of FORXIGA 10 mg + metformin (1500 mg/day) versus placebo + metformin (1500 mg/day) in adult patients with Type 2 diabetes who had inadequate glycaemic control (HbA1c 7% and 10%) on metformin alone. Primary endpoint: HbA1c reduction at 24 weeks. Bailey CJ, et al. Lancet 2010;375:222333.

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FORXIGA: Reductions in HbA1c were sustained over time

0.2 Adjusted mean change from baseline HbA1c (%) 0.0 -0.2 -0.4 -0.6 -0.8 -1.0 0 8 16 24 37 50 63 Study week 76 89 102
FORXIGA 10 mg + metformin
(Mean baseline HbA1c 7.95%)

Primary endpoint 24 weeks (n=133) (n=132)

Placebo + metformin
(Mean baseline HbA1c 8.13%)

+0.02%
(95% Cl, 0.20 to 0.23%; n=28)

0.80%
difference

0.78%
(95% Cl, 0.97 to 0.60%; n=57)

Data are mean change from baseline after adjustment for baseline value. Data after rescue are excluded. Analyses were obtained by longitudinal repeated measures analyses. CI, confidence interval. Bailey CJ, et al. Diabetes 2011;60(Suppl. 1):988-P.

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FORXIGA also had the additional benefit of weight loss over time
24 weeks (LOCF analysis)1 2.0 Adjusted mean change from baseline body weight (kg) 1.0 0.0 0.9 kg -1.0 -2.0 1.7 kg -3.0 -4.0 2.9 kg
(n=133) (n=136)

102 weeks (repeated measures analysis)2

FORXIGA 10 mg + metformin Placebo + metformin

FORXIGA 10 mg + metformin

Placebo + metformin

+1.4 kg
(n=73)

3.1 kg
difference

2.0 kg
difference p<0.0001

(n=95)

In a separate dedicated weight loss study, weight loss in patients treated with FORXIGA came from fat mass reduction3
Data are mean change from baseline after adjustment for baseline value (mean baseline weight: FORXIGA 86.3 kg, placebo 87.7 kg). 24-week data are based on LOCF analysis excluding data after rescue; 102-week data are based on longitudinal repeated measures analysis and include data after rescue. 1. Bailey CJ, et al. Lancet 2010;375:222333; 2. Bailey CJ, et al. Diabetes 2011;60(Suppl. 1):988-P; 3. Bolinder J, et al. J Clin Endocrinol Metab 2012;97:102031.

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FORXIGA: Comparable HbA1c reduction to a sulphonylurea at the 52-week primary endpoint

FORXIGA 10 mg + metformin 52 weeks Glipizide + metformin

0 Adjusted mean change from baseline HbA1c (%) -0.1 -0.2 -0.3 -0.4 -0.5 -0.6

0.52%
(95% Cl, 0.60 to 0.44%) n=400 Mean baseline HbA1c 7.69%

0.52%
(95% Cl, 0.60 to 0.44%)
n=401 Mean baseline HbA1c 7.74%

Data are adjusted mean change from baseline and 95% CI derived from analysis of covariance using the full analysis set and LOCF values. A Phase III, multicentre, randomised, double-blind, parallel-group, 52-week, glipizide-controlled non-inferiority study to evaluate the efficacy and safety of FORXIGA 10 mg + metformin (1500 mg/day) versus glipizide + metformin (1500 mg/day) in patients with inadequate glycaemic control (HbA1c >6.5% and 10%) on metformin alone. Nauck MA, et al. Diabetes Care 2011;34:201522.

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FORXIGA: Reductions in HbA1c were sustained over 104 weeks

0.2 Adjusted mean change from baseline HbA1c (%) 0.0 -0.2 -0.4 -0.6 -0.8 -1.0
Glipizide + metformin (n=401) FORXIGA 10 mg + metformin
(n=400)

0.14%
(95% Cl, 0.25 to 0.03%; n=208)

0.32%
(95% Cl, 0.42 to 0.21%; n=233)

12

18

26

34

42

52

65

78

91

104

Study week

Data are adjusted mean change from baseline and 95% CI derived from a repeated measures mixed model. 1. Nauck MA, et al. Diabetes Care 2011;34:201522; 2. Nauck MA, et al. Diabetes 2011;60(Suppl. 1):Poster 40-LB.

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Lower incidence of hypoglycaemia with FORXIGA compared with a sulphonylurea

45 40 Patients with 1 episode of hypoglycaemia (%) 35 30 25 20 15 10 5 0 FORXIGA 10 mg + metformin 52 weeks

Nauck MA, et al. Diabetes Care 2011;34:201522.

p<0.0001

40.8% (n=401)

3.5% (n=406) Glipizide + metformin

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FORXIGA: Additional benefit of weight loss sustained over time

Glipizide + metformin

2.0 1.5 1.0 0.5 0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 -3.5 -4.0

(n=401) Mean baseline weight 87.6 kg

Adjusted mean change from baseline weight (kg)

+1.36 kg
(95% Cl, 0.88 to 1.84 kg; n=211)

5.06 kg difference
(95% Cl, 5.73 to 4.4 kg)

FORXIGA 10 mg + metformin
(n=400) Mean baseline weight 88.4 kg

3.70 kg
(95% Cl, 4.16 to 3.24 kg; n=234)

12 18

26

34

42

52 Study week

65

78

91

104

Data are adjusted mean change from baseline and 95% CI derived from a repeated measures mixed model. 1. Nauck MA, et al. Diabetes Care 2011;34:201522; 2. Nauck MA, et al. Diabetes 2011;60(Suppl. 1):Poster 40-LB.

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FORXIGA: Reduction in blood pressure

In a prespecified pooled analysis of 12 placebo-controlled studies, FORXIGA 10 mg reduced systolic and diastolic blood pressure versus placebo at Week 241
Systolic blood pressure 0.0 Mean change in blood pressure (mmHg) -1.0 -2.0 2.1 mmHg -3.0 -4.0 -5.0
Baseline blood pressure2

Diastolic blood pressure

FORXIGA 10 mg Control groups

FORXIGA 10 mg

Control groups

0.5 mmHg 0.9 mmHg

(n=1096) (n=1096)

(n=949)

4.4 mmHg
(n=949)
126 mmHg 129 mmHg 77 mmHg 79 mmHg

FORXIGA is not indicated for the management of high blood pressure. Mean seated systolic and diastolic blood pressure were based on a placebo-controlled, pooled analysis from the 24-week, short-term, double-blind treatment period, including data after rescue. N is the number of subjects with non-missing baseline and Week 24 (LOCF) values in the randomised full analysis set. Change in blood pressure was primarily assessed as safety or exploratory efficacy endpoints in the Phase III clinical programme; therefore, the background antihypertensive medications were not controlled. 1. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012; 2. BMS/AZ data on file.

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Pooled safety and tolerability data

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Safety and tolerability data from a comprehensive clinical programme

The overall incidence of adverse events (short-term treatment) in subjects treated with FORXIGA 10 mg was similar to placebo
Adverse reactions in placebo-controlled studies of FORXIGA (24-week data regardless of glycaemic rescue)
System organ class Infections and infestations Very common (10%) Common* (1% to <10%) Vulvovaginitis, balanitis and related genital infections UTIs Hypoglycaemia (when used with a SU or insulin) Uncommon (0.1% to <1%) Vulvovaginal pruritus

Metabolism and nutrition disorders

Volume depletion Thirst Constipation Hyperhidrosis Back pain Dysuria Polyuria Dyslipidaemia Haematocrit increased Nocturia Blood creatinine increased Blood urea increased

Gastrointestinal disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders Renal and urinary disorders Investigations

SU, sulphonylurea; UTI, urinary tract infection. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Rate of hypoglycaemia depends on background therapy being used

Across all studies, events of hypoglycaemia were comparable between FORXIGA or placebo* The frequency of hypoglycaemia depended on the type of background therapy used in each study Studies of FORXIGA as add-on to sulphonylurea and add-on to insulin therapies had higher rates of hypoglycaemia
Frequency of minor episodes of hypoglycaemia FORXIGA Placebo All studies <4% <4% Add-on to sulphonylurea 6.0% 2.1% Add-on to insulin 40.3% 34.0%

*In a prespecified pooled analysis of 12 placebo-controlled studies. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Events of volume depletion similar to control at 24 weeks

Frequency of reactions related to volume depletion* FORXIGA 10 mg Control

*Including dehydration, hypovolaemia, or hypotension.

All events 0.8% 0.4%

Serious events occurred in <0.2% of patients and were comparable between groups

FORXIGA is not recommended for initiation of therapy in patients who are volume depleted. Temporary interruption of Forxiga is recommended for patients who develop volume depletion until the depletion is corrected. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Genital infections and urinary tract infections*

Most genital infections and UTIs were mild to moderate, responded to initial course of standard therapy, and rarely led to discontinuation of FORXIGA Events of genital infection (vulvovaginitis, balanitis and related genital infections) and UTIs with FORXIGA 10 mg versus placebo: Frequency at 24 weeks FORXIGA 10 mg Placebo Genital infections Overall 4.8% 0.9% Female patients 9.7% 3.4% UTIs 4.3% 3.7%

Pyelonephritis was uncommon and occurred at a similar frequency to control

*In a prespecified pooled analysis of 12 placebo-controlled studies; Genital infection includes the preferred terms, listed in order of frequency reported: Vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, and vulval abscess. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Cardiovascular safety
FORXIGA is not associated with an increase in cardiovascular risk in patients with Type 2 diabetes*
2.5

Frequency of primary episodes (%)

2.0

Hazard ratio 0.82 (95% CI 0.58, 1.15) 1.99 % per patient per year 1.64% per patient per year

1.5

1.0

0.5

0.0

FORXIGA

Control

*In a meta-analysis of cardiovascular events in 19 double-blind clinical studies of FORXIGA 2.510 mg adjudicated by an independent committee. Cardiovascular death, stroke, myocardial infarction or hospitalisation for unstable angina.
FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Dosing and administration

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FORXIGA: A convenient, once-daily tablet

In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased to 10 mg No known drugdrug interactions with other commonly prescribed Type 2 diabetes treatments
FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Considerations for FORXIGA dosage and administration (1)

The efficacy of FORXIGA is dependent on renal function FORXIGA is not recommended for use in patients with moderate to severe renal impairment (CrCl <60 mL/min or eGFR <60 mL/min/1.73 m2) The monitoring of renal function is recommended as follows: Prior to initiation of FORXIGA and at least yearly, thereafter Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter For renal function approaching moderate renal impairment, at least 2 to 4 times per year. If renal function falls below CrCl <60 mL/min or eGFR <60 mL/min/1.73 m2, FORXIGA treatment should be discontinued

*eGFR calculated with Modification of Diet in Renal Disease Formula. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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Considerations for FORXIGA dosage and administration (2)

FORXIGA is not recommended in: Patients aged 75 years or <18 years Patients treated concomitantly with pioglitazone Patients receiving loop diuretics FORXIGA is also not recommended for initiation of therapy in patients who are volume depleted Temporary interruption of FORXIGA is recommended for patients who develop volume depletion until the depletion is corrected Caution should be exercised in patients for whom a FORXIGA-induced drop in blood pressure could pose a risk A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with FORXIGA
FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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FORXIGA: Considerations for patients

As with all medicines, patients will benefit most if they understand what they are taking and the importance of lifestyle and exercise as adjuncts to successful treatment outcomes: FORXIGA has a simple mechanism of action that means that excess glucose is removed via the urine FORXIGA reduces blood glucose levels and has the additional benefit of weight loss For the best outcomes, adherence is important as well healthy eating and exercise

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Summary
FORXIGA, a first-in-class SGLT2 inhibitor, removes excess glucose via an insulin-independent mechanism of action and provides: Significant and sustained HbA1c reductions15 Additional benefits of weight loss15 and a reduction in blood pressure1,5 Low incidence of hypoglycaemia1 In one 10 mg tablet a day5* Add on for patients uncontrolled on metformin who need the additional benefit of weight loss and have normal or only mildly impaired renal function
*In patients with severe hepatic impairment, a starting dose of 5 mg is recommended. If well tolerated, the dose may be increased up to 10 mg. 1. Bailey CJ, et al. Lancet 2010;375:222333; 2. Bailey CJ, et al. Diabetes 2011;60(Suppl. 1):988-P; 3. Nauck MA, et al. Diabetes Care 2011;34:201522; 4. Nauck MA, et al. Diabetes 2011;60(Suppl. 1):Poster 40-LB; 5. FORXIGA. Summary of product characteristics. Bristol-Myers Squibb/AstraZeneca EEIG, 2012.

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