Efficacy - Jardiance® (empagliflozin) tablets

FOR ADULTS WITH TYPE 2 DIABETES, ALONG WITH DIET AND EXERCISE

A1C results when adding JARDIANCE to metformin

In addition, JARDIANCE reduced weight and SBP as early as 24 weeks in a placebo-controlled, glucose-lowering study of JARDIANCE as add-on to metformin*

A1C REDUCTION FROM BASELINE

Mean change from baseline (7.9%), (n=213)

UP TO

-0.8^%

at week 24

Adjusted mean changes of -0.1% from a baseline of 7.9% for placebo (n=207), -0.7% from a baseline of 7.9% for JARDIANCE 10 mg (n=217), and -0.8% for JARDIANCE 25 mg (n=213), respectively. Difference from placebo + metformin (adjusted mean) was -0.6% for both JARDIANCE 10 mg and 25 mg; p<0.0001 vs placebo.

Subgroup analysis, baseline ≥8.5% (n=48)¹

UP TO

-1.5^%

at week 24

In a prespecified subgroup analysis of patients with baseline <8.5%, adjusted mean changes in A1C were -0.02% for placebo (n=157), -0.5% for JARDIANCE 10 mg (n=160), and -0.5% for JARDIANCE 25 mg (n=165). Difference from placebo (adjusted mean) was -0.5% for JARDIANCE 10 mg and -0.5% for JARDIANCE 25 mg; p<0.0001 vs placebo. In a subgroup analysis of patients with baseline ≥8.5%, adjusted mean changes in A1C were -0.5% for placebo (n=50), -1.2% for JARDIANCE 10 mg (n=57), and -1.5% for JARDIANCE 25 mg (n=48). Difference from placebo (adjusted mean) was -0.73% for JARDIANCE 10 mg and -1.0% for JARDIANCE 25 mg.

WEIGHT REDUCTION FROM BASELINE

Mean change from baseline (BMI 29.7, 181 lb), (n=213)

UP TO

-5.2 LB

at week 24

Adjusted mean changes of -0.5% reduction in body weight (-0.9 lb) from a baseline of 176 lb for placebo (n=207), -2.5% (-4.5 lb) from a baseline of 180 lb for JARDIANCE 10 mg (n=217), and -2.9% (-5.2 lb) from a baseline of 181 lb for JARDIANCE 25 mg, respectively; p<0.0001 vs placebo.

Subgroup analysis, baseline BMI≥35 (237 lb), (n=41)¹

UP TO

-7.4 LB

at week 24

UP TO

-10.5 LB

at week 76

In a prespecified subgroup analysis at week 24, adjusted mean changes in weight for placebo were -0.9 lb (BMI <25, n=52), -0.9 lb (BMI 25 - <30, n=83), -1.0 lb (BMI 30 - <35, n=43), and -0.7 lb (BMI ≥35, n=29). Adjusted mean changes in weight for JARDIANCE 10 mg and 25 mg were -3.5 lb and -3.4 lb (BMI <25, n=45, n=40), -4.1 lb and -5.1 lb (BMI 25 - <30, n=96, n=81), -6.1 lb and -6.2 lb (BMI 30 - <35, n=43, n=51), and -5.8 lb and -7.4 lb (BMI ≥35, n=33, n=41), respectively. Difference from placebo (adjusted mean) for JARDIANCE 10 mg and 25 mg were -2.7 lb and -2.5 lb (BMI <25), -3.1 lb and -4.1 lb (BMI 25 - <30), -5.0 lb and -5.2 lb (BMI 30 - <35), and -5.0 lb and -6.6 lb (BMI ≥35), respectively. In a prespecified subgroup analysis at week 76, adjusted mean changes in weight for placebo were -1.1 lb (BMI <25, n=52), -1.2 lb (BMI 25 - <30, n=83), -0.9 lb (BMI 30 - <35, n=43), and 0.5 lb (BMI ≥35, n=29). Adjusted mean changes in weight for JARDIANCE 10 mg and 25 mg were -3.1 lb and -3.7 lb (BMI <25, n=45, n=40), -5.0 lb and -4.6 lb (BMI 25 - <30, n=96, n=81), -6.0 lb and -6.2 lb (BMI 30 - <35, n=43, n=51), and -8.2 lb and -10.5 lb (BMI ≥35, n=33, n=41), respectively. Difference from placebo (adjusted mean) for JARDIANCE 10 mg and 25 mg were -1.9 lb and -2.6 lb (BMI <25), -3.8 lb and -3.3 lb (BMI 25 - <30), -5.1 lb and -5.3 lb (BMI 30 - <35), and -8.7 lb and -11.0 lb (BMI ≥35), respectively.

SYSTOLIC BLOOD PRESSURE REDUCTION FROM BASELINE²

Systolic blood pressure was reduced by up to -4.8 mmHg from a baseline of 130 mmHg at week 24

Placebo-corrected mean changes of -4.1 mmHg from a baseline of 129.6 mmHg for JARDIANCE 10 mg and -4.8 mmHg from a baseline of 130.0 mmHg for JARDIANCE 25 mg; JARDIANCE vs placebo p<0.0001 for both doses.

^*JARDIANCE is not indicated for weight loss or blood pressure reduction. Weight loss and SBP reduction were secondary endpoints.³

TRIAL DESIGN

Add-on to metformin: A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE (10 mg, 25 mg) administered orally once daily over 24 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control despite treatment with metformin ≥1500 mg alone. Six hundred thirty-seven treated patients received placebo + metformin (N=207), JARDIANCE 10 mg + metformin (N=217), or JARDIANCE 25 mg + metformin (N=213). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.²

BMI=body mass index; SBP=systolic blood pressure.

References

Reduced Risk of CV Death

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Do more to fight CV death: Add JARDIANCE as part of your standard of care

HR=0.62 (95% Cl: 0.49-0.77)

PATIENTS WERE ACTIVELY MANAGED WITH STANDARD OF CARE MEDICATIONS^1†

CARDIOVASCULAR MEDICATIONS

including ACEIs/ARBs, aspirin, statins, and beta blockers.
TYPE 2 DIABETES MEDICATIONS

including metformin, insulin, DPP-4 inhibitors, GLP-1 agonists, SUs, and TZDs.

Trial Design

PRIMARY COMPOSITE ENDPOINT

JARDIANCE demonstrated a 14% RRR (HR=0.86 [95% Cl: 0.74-0.99]; p=0.04).

The absolute risk reduction for the composite endpoint was 1.6%.

There was no change in risk of nonfatal MI (HR=0.87 [95% CI: 0.70-1.09]) or nonfatal stroke (HR=1.24 [95% CI: 0.92-1.67]); the 14% RRR in CV events was due to a reduction in the risk of CV death (HR=0.62 [95% CI: 0.49-0.77]).

Number needed to treat (NNT) to prevent one CV death (median 3.1 years)¹

NNT is the number of patients that need to be treated to prevent one death.

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Without JARDIANCE added to their standard of care, more patients died of CV events

JARDIANCE reduced the risk of CV death early and results were consistent for both dosing strengths¹

38% RRR IN CV DEATH

2.2% ARR* HR=0.62 (95% Cl: 0.49-0.77)

Early and sustained reduction in CV death

Placebo
+ CV and glucose-lowering medications (N=2333)
JARDIANCE
+ CV and glucose-lowering medications (N=4687)

CVD Subgroup Analysis

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Reduced risk of CV death was observed in patients with different types of established CV disease and T2D^2‡

POST-HOC ANALYSIS: REDUCTION IN RISK OF CV DEATH ACROSS CVD SUBGROUPS

PERIPHERAL ARTERY DISEASE
CORONARY ARTERY DISEASE
HISTORY OF MI
HISTORY OF STROKE

REDUCTIONS WERE SEEN IN PATIENTS WITH AND WITHOUT A PRIOR CV EVENT

Post-hoc Analysis: CV death was analyzed in subgroups by type of CV disease at baseline. Differences between treatment groups were assessed using Cox regression analysis in patients treated with ≥1 dose of study drug. The post-hoc analysis was not designed to determine statistical significance.
Rate of CV death (%) across CVD subgroups: All values depict JARDIANCE vs placebo, respectively. With PAD, 4.5 vs 7.5; without, 3.5 vs 5.5. With CAD, 3.7 vs 5.8; without, 3.8 vs 5.9. With history of MI, 4.6 vs 7.6; without, 2.8 vs 4.4. With history of stroke, 4.3 vs 8.0; without, 3.5 vs 5.2.

A1C Subgroup Analysis

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

JARDIANCE demonstrated consistent reductions in CV death across A1C subgroups^2§

A1C AT BASELINE

<7.0%
7.0% - <8.0%
8.0% - <9.0%
≥9.0%

A1C CHANGE FROM BASELINE

Reduction of ≥0.3%
Reduction of <0.3% or increase

Post-hoc Analysis: Risk of CV death was analyzed in the placebo and pooled JARDIANCE groups according to baseline A1C and change in A1C from baseline to the last value in the trial. A Cox proportional hazards model was used to assess the differences between the treatment groups. The post-hoc analysis was not designed to determine statistical significance.
Rate of CV death (%) across A1C subgroups: All values depict JARDIANCE vs placebo, respectively. <7.0%: 2.4 (N=297) vs 7.9 (N=127); 7.0%–<8.0%: 3.7 (N=2042) vs 6.1 (N=1029); 8.0%–<9.0%: 3.7 (N=1534) vs 5.4 (N=795); ≥9.0%: 4.2 (N=812) vs 5.5 (N=382).

^*Absolute rates for CV death: 5.9% placebo vs 3.7% JARDIANCE. Pooled data from JARDIANCE 10 mg and JARDIANCE 25 mg; similar magnitude of reduction was shown with both doses.
^†Type 2 diabetes medications were kept stable for the first 12 weeks.
^‡Established CVD consisted of peripheral artery disease, coronary artery disease, or a history of MI or stroke.¹
^§A pre-specified analysis included subgroups of patients with A1C <8.5% and ≥8.5%.¹

ACEIs=angiotensin-converting enzyme inhibitors; ARBs=angiotensin II receptor blockers; ARR=absolute risk reduction; CAD=coronary artery disease; CI=conﬁdence interval; CV=cardiovascular; CVD=cardiovascular disease; DPP-4=dipeptidyl peptidase-4; GLP-1=glucagon-like peptide 1; HR=hazard ratio; MI=myocardial infarction; PAD=peripheral artery disease; RRR=relative risk reduction; SU=sulfonylurea; T2D=type 2 diabetes; TZD=thiazolidinedione.

References

AS PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

The EMPA-REG OUTCOME Trial studied 7020 patients over a median of 3.1 years¹

Patients studied had:

Established CV disease

evidenced by coronary artery disease, peripheral artery disease, or a history of myocardial infarction or stroke.

Established CV Disease Definitions

Type 2 diabetes

A1C baseline of ≥7%-≤10%

Patients were randomized to receive placebo or JARDIANCE, an SGLT2 inhibitor:

Placebo + standard of care (N=2333)
JARDIANCE 10 mg + standard of care (N=2345)
JARDIANCE 25 mg + standard of care (N=2342)

These patients were receiving standard of care medications¹^*

CARDIOVASCULAR MEDICATIONS
ACEIs/ ARBs	STATINS	ASPIRIN	BETA BLOCKERS
81%	77%	83%	65%

TYPE 2 DIABETES MEDICATIONS
METFORMIN	TWO OR MORE TYPE 2 DIABETES MEDICATIONS
74%	~70%

Investigators were encouraged to manage CV risk factors and blood glucose by actively adjusting all medications in order to achieve appropriate treatment goals in all treatment groups.

THE EMPA-REG OUTCOME TRIAL was a prospective study designed to investigate CV outcomes. It was not a treat-to-target study designed to evaluate glucose lowering.

^*Percentages reflect medications taken at baseline. Type 2 diabetes medications were kept stable for the first 12 weeks.

References

ACROSS MULTIPLE TRIALS

JARDIANCE has a demonstrated safety and tolerability profile

The safety profile in the EMPA-REG OUTCOME Trial was consistent with that of previous trials

COMMON AEs IN EMPA-REG OUTCOME TRIAL¹
	PLACEBO	JARDIANCE^*
Urinary tract infection	18.1%	18.0%
Genital mycotic infection	1.8%	6.4%

COMMON AEs IN MONOTHERAPY AND COMBINATION THERAPY TRIALS^†
	PLACEBO (N=995)	JARDIANCE 10 MG (N=999)	JARDIANCE 25 MG (N=977)
Urinary tract infection	7.6%	9.3%	7.6%
UTIs: Males	3.2%	3.6%	4.1%
UTIs: Females	16.6%	18.4%	17.0%
Female genital mycotic infections	1.5%	5.4%	6.4%
Upper respiratory tract infection	3.8%	3.1%	4.0%
Increased urination	1.0%	3.4%	3.2%
Dyslipidemia	3.4%	3.9%	2.9%
Arthralgia	2.2%	2.4%	2.3%
Male genital mycotic infections	0.4%	3.1%	1.6%
Nausea	1.4%	2.3%	1.1%

SELECT AEs IN EMPA-REG OUTCOME TRIAL^1,2
	PLACEBO	JARDIANCE 10 MG	JARDIANCE 25 MG
Lower limb amputation^‡	1.8%	1.8%	2.0%
Bone fracture	3.9%	3.9%	3.7%

JARDIANCE as monotherapy or add-on to metformin demonstrated similar hypoglycemia rates compared with placebo

MONOTHERAPY (24 WEEKS)
PLACEBO (N=229)	JARDIANCE 10 mg (N=224)	JARDIANCE 25 mg (N=223)
Overall (plasma glucose ≤70 mg/dL)	0.4%	0.4%	0.4%
Severe (requiring assistance regardless of blood glucose)	0%	0%	0%

ADD-ON TO METFORMIN (24 WEEKS)
PLACEBO (N=206)	JARDIANCE 10 mg (N=217)	JARDIANCE 25 mg (N=214)
Overall (plasma glucose ≤70 mg/dL)	0.5%	1.8%	1.4%
Severe (requiring assistance regardless of blood glucose)	0%	0%	0%

When used in combination with sulfonylurea or insulin, hypoglycemia rates were higher

ADD-ON TO METFORMIN + SULFONYLUREA (24 WEEKS)
PLACEBO (N=225)	JARDIANCE 10 mg (N=224)	JARDIANCE 25 mg (N=217)
Overall (plasma glucose ≤70 mg/dL)	8.4%	16.1%	11.5%
Severe (requiring assistance regardless of blood glucose)	0%	0%	0%

ADD-ON TO BASAL INSULIN ± ORALS^§,|| (18 WEEKS)
PLACEBO (N=170)	JARDIANCE 10 mg (N=169)	JARDIANCE 25 mg (N=155)
Overall (plasma glucose ≤70 mg/dL)	20.6%	19.5%	28.4%
Severe (requiring assistance regardless of blood glucose)	0.0%	0.0%	1.3%

A LOWER DOSE OF INSULIN AND INSULIN SECRETAGOGUES (EG, SULFONYLUREAS) MAY BE REQUIRED TO REDUCE THE RISK OF HYPOGLYCEMIA WHEN JARDIANCE IS USED IN COMBINATION WITH THESE AGENTS

^*Pooled data from JARDIANCE 10 mg and JARDIANCE 25 mg.¹
^†Adverse events, excluding hypoglycemia, reported in pooled, placebo-controlled clinical studies in ≥2% of patients treated with JARDIANCE and greater than placebo.
^‡In the EMPA-REG OUTCOME Trial, procedures such as amputations were classified as therapeutic procedures and were not routinely captured as adverse events. Post-hoc analyses of amputations in the clinical trial database were performed by searching concomitant therapies, comment fields for adverse event listings, and case narratives.²
^§Basal insulin study: No insulin adjustment during the first 18 weeks.
^||Orals included metformin and/or a sulfonylurea.
AE=adverse event; UTI=urinary tract infection.

Study Designs

References

The 2020 American Diabetes Association® Standards of Care recommends SGLT2 inhibitors, which includes empagliflozin as a 2nd-line treatment¹ option when adult patients with T2D have established CV disease - independent of baseline A1C

The ADA® Standards of Care recommends an SGLT2 inhibitor as a 2nd-line treatment option when A1C is above target and when there is a need for weight loss^1*

Both the ADA® Standards of Care and the American College of Cardiology Expert Consensus Decision Pathway recommend SGLT2 inhibitors to help manage cardiovascular outcomes.^1,2

*JARDIANCE is not indicated for weight loss or blood pressure reduction.³

ACC=American College of Cardiology;
ADA=American Diabetes Association;
SGLT2=sodium glucose co-transporter-2.

See the recommendation at www.diabetes.org.

References

INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

JARDIANCE is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease.

JARDIANCE is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: History of serious hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, severe renal impairment, end-stage renal disease, or dialysis.

WARNINGS AND PRECAUTIONS

Hypotension: Empagliflozin causes intravascular volume contraction and symptomatic hypotension may occur. Before initiating JARDIANCE, assess and correct volume status in the elderly, and in patients with renal impairment, low systolic blood pressure, or on diuretics. Monitor for hypotension.

Ketoacidosis: Ketoacidosis, a serious life-threatening condition requiring urgent hospitalization, has been identified in patients with type 1 and type 2 diabetes mellitus receiving SGLT2 inhibitors, including empagliflozin. Fatal cases of ketoacidosis have been reported in patients taking empagliflozin. Patients who present with signs and symptoms of metabolic acidosis should be assessed for ketoacidosis, even if blood glucose levels are less than 250 mg/dL. If suspected, discontinue JARDIANCE, evaluate, and treat promptly. Before initiating JARDIANCE, consider risk factors for ketoacidosis. Patients may require monitoring and temporary discontinuation in situations known to predispose to ketoacidosis. For patients who undergo scheduled surgery, consider temporarily discontinuing JARDIANCE for at least 3 days prior to surgery.

Acute Kidney Injury and Impairment in Renal Function: Empagliflozin causes intravascular volume contraction and can cause renal impairment. Acute kidney injury requiring hospitalization and dialysis has been identified in patients taking SGLT2 inhibitors, including empagliflozin; some reports involved patients younger than 65 years of age. Before initiating JARDIANCE, consider factors that may predispose patients to acute kidney injury. Consider temporary discontinuation in settings of reduced oral intake or fluid losses. Monitor patients for signs and symptoms of acute kidney injury. If it occurs, discontinue JARDIANCE and treat promptly.

Empagliflozin increases serum creatinine and decreases eGFR. Patients with hypovolemia may be more susceptible to these changes. Before initiating JARDIANCE, evaluate renal function and monitor thereafter. More frequent monitoring is recommended in patients with eGFR <60 mL/min/1.73 m². Discontinue JARDIANCE in patients with a persistent eGFR <45 mL/min/1.73 m².

Urosepsis and Pyelonephritis: Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including empagliflozin. Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate for signs and symptoms of urinary tract infections and treat promptly.

Hypoglycemia: The use of JARDIANCE in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. A lower dose of insulin or the insulin secretagogue may be required.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases requiring urgent surgical intervention have occurred in both females and males. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, institute prompt treatment and discontinue JARDIANCE.

Genital Mycotic Infections: Empagliflozin increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with JARDIANCE (angioedema). If hypersensitivity reactions occur, discontinue JARDIANCE, treat promptly, and monitor until signs and symptoms resolve.

Increased Low-Density Lipoprotein Cholesterol (LDL-C): Monitor and treat as appropriate.

MOST COMMON ADVERSE REACTIONS (≥5%): Urinary tract infections and female genital mycotic infections.

DRUG INTERACTIONS: Coadministration with diuretics may enhance the potential for volume depletion.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended, especially during the second and third trimesters.

Lactation: JARDIANCE is not recommended while breastfeeding.

Geriatric Use: JARDIANCE is expected to have diminished efficacy in elderly patients with renal impairment. Renal function should be assessed more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in patients ≥75 years treated with empagliflozin.

CL-JAR-100056 01.27.2020

Please see JARDIANCE Prescribing Information, including Medication Guide.

FOR ADULTS WITH TYPE 2 DIABETES, ALONG WITH DIET AND EXERCISE

A1C results when adding JARDIANCE to metformin

In addition, JARDIANCE reduced weight and SBP as early as 24 weeks in a placebo-controlled, glucose-lowering study of JARDIANCE as add-on to metformin*

A1C REDUCTION FROM BASELINE

WEIGHT REDUCTION FROM BASELINE

SYSTOLIC BLOOD PRESSURE REDUCTION FROM BASELINE²

Systolic blood pressure was reduced by up to -4.8 mmHg from a baseline of 130 mmHg at week 24

*JARDIANCE is not indicated for weight loss or blood pressure reduction. Weight loss and SBP reduction were secondary endpoints.³

TRIAL DESIGN

Reduced Risk of CV Death

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Do more to fight CV death: Add JARDIANCE as part of your standard of care

PATIENTS WERE ACTIVELY MANAGED WITH STANDARD OF CARE MEDICATIONS1†

CARDIOVASCULAR MEDICATIONS

TYPE 2 DIABETES MEDICATIONS

PRIMARY COMPOSITE ENDPOINT

Number needed to treat (NNT) to prevent one CV death (median 3.1 years)1

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Without JARDIANCE added to their standard of care, more patients died of CV events

38% RRR IN CV DEATH

2.2% ARR* HR=0.62 (95% Cl: 0.49-0.77)

CVD Subgroup Analysis

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

Reduced risk of CV death was observed in patients with different types of established CV disease and T2D2‡

POST-HOC ANALYSIS: REDUCTION IN RISK OF CV DEATH ACROSS CVD SUBGROUPS

A1C Subgroup Analysis

FOR ADULTS WITH ESTABLISHED CV DISEASE AND TYPE 2 DIABETES

JARDIANCE demonstrated consistent reductions in CV death across A1C subgroups2§

A1C AT BASELINE

A1C CHANGE FROM BASELINE

AS PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

The EMPA-REG OUTCOME Trial studied 7020 patients over a median of 3.1 years1

Patients studied had:

Established CV disease

Type 2 diabetes

Patients were randomized to receive placebo or JARDIANCE, an SGLT2 inhibitor:

These patients were receiving standard of care medications1*

Which of these medications do you commonly prescribe for adults with established CV disease and type 2 diabetes?

Check all that apply

ACROSS MULTIPLE TRIALS

JARDIANCE has a demonstrated safety and tolerability profile

JARDIANCE as monotherapy or add-on to metformin demonstrated similar hypoglycemia rates compared with placebo

When used in combination with sulfonylurea or insulin, hypoglycemia rates were higher

The 2020 American Diabetes Association® Standards of Care recommends SGLT2 inhibitors, which includes empagliflozin as a 2nd-line treatment1 option when adult patients with T2D have established CV disease - independent of baseline A1C

How important is the American Diabetes Association® Standards of Care when choosing treatment for your patients?

INDICATIONS AND LIMITATIONS OF USE

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

USE IN SPECIAL POPULATIONS

^*JARDIANCE is not indicated for weight loss or blood pressure reduction. Weight loss and SBP reduction were secondary endpoints.³

PATIENTS WERE ACTIVELY MANAGED WITH STANDARD OF CARE MEDICATIONS^1†

Number needed to treat (NNT) to prevent one CV death (median 3.1 years)¹

Reduced risk of CV death was observed in patients with different types of established CV disease and T2D^2‡

JARDIANCE demonstrated consistent reductions in CV death across A1C subgroups^2§

The EMPA-REG OUTCOME Trial studied 7020 patients over a median of 3.1 years¹

These patients were receiving standard of care medications¹^*

The 2020 American Diabetes Association® Standards of Care recommends SGLT2 inhibitors, which includes empagliflozin as a 2nd-line treatment¹ option when adult patients with T2D have established CV disease - independent of baseline A1C