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

Choose Jardiance® (empagliflozin) tablets as early as first line to help your patients go beyond A1C control

A1C reductions when used as monotherapy and add-on to metformin

JARDIANCE reduced A1C as early as 24 weeks in 2 placebo-controlled, glucose-lowering studies of JARDIANCE as monotherapy and as add-on to metformin.

T2D efficacy A1C Reductions
  • * Adjusted mean changes of 0.1% from a baseline of 7.9% for placebo (n=228), -0.7% from a baseline of 7.9% for JARDIANCE 10 mg (n=224), and -0.8% for JARDIANCE 25 mg (n=224), respectively. Difference from placebo (adjusted mean) was -0.7% from a baseline of 7.9% for JARDIANCE 10 mg and -0.9% for JARDIANCE 25 mg; P<0.0001 vs placebo.1
  • † 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.
  • ‡ In patients with HbA1c concentrations ≥8.5% at baseline, adjusted mean changes from baseline in HbA1c were .01% with placebo (n=51), -1.44% with JARDIANCE 10 mg (n=54), and -1.43% with JARDIANCE 25 mg (n=45). In patients with HbA1c concentrations ≤8.5% at baseline, mean differences of -0.49% from a baseline of ~7.5% for JARDIANCE 10 mg and -0.68% from a baseline of ~7.5% for JARDIANCE 25 mg.3
  • § 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. 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.1

SUSTAINED A1C REDUCTIONS AT WEEK 761,4

Monotherapy: At week 76, adjusted mean changes of 0.13% from a baseline of 8.0% for placebo (n=228), -0.6% from a baseline of 7.2% for JARDIANCE 10 mg (n=224), and -0.7% for JARDIANCE 25 mg (n=224), respectively. Difference vs placebo (adjusted mean) was -0.8% for JARDIANCE 10 mg and -0.9% for JARDIANCE 25 mg; P<0.001.4

Add-on to metformin: At week 76, adjusted mean changes of -0.01% from a baseline of 7.9% for placebo (n=207), -0.62% from a baseline of 7.9% for JARDIANCE 10 mg (n=217), and -0.74% for JARDIANCE 25 mg (n=213), respectively. Difference from placebo + metformin (adjusted mean) was -0.61% for JARDIANCE 10 mg and -0.73% for JARDIANCE 25 mg; P<0.0001 vs placebo.1

  

Open

Monotherapy trial design:

A Phase III, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of JARDIANCE administered orally once daily over 24 weeks in treatment-naïve patients with type 2 diabetes mellitus with insufficient glycemic control. A total of 676 treated patients received placebo (n=228), JARDIANCE 10 mg (n=224), or JARDIANCE 25 mg (n=224). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.1

Add-on to metformin trial design:

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE 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

  

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

Weight reductions when used as monotherapy and add-on to metformin*

In addition, JARDIANCE reduced weight as early as 24 weeks in 2 placebo-controlled, glucose-lowering studies of JARDIANCE as monotherapy and as add-on to metformin.*

 

T2D efficacy Weight Reductions

* JARDIANCE is not indicated for weight loss. Change in body weight from baseline was a secondary endpoint.

  • † Adjusted mean changes of -0.4% reduction in body weight (-0.7 lb) from a baseline of 172 lb for placebo (n=228), -2.8% (-5.0 lb) from a baseline of 172 lb for JARDIANCE 10 mg (n=224), and -3.2% (-5.5 lb) from a baseline of 172 lb for JARDIANCE 25 mg (n=224), respectively; P<0.0001 vs placebo.1,3
  • ‡ 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 181 lb for JARDIANCE 10 mg (n=217), and -2.9% (-5.2 lb) from a baseline of 181 lb for JARDIANCE 25 mg (n=213); P<0.0001 vs placebo.
  • § 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.1
  • || 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.1

   

Open

Monotherapy trial design:

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE (10 mg, 25 mg) administered orally over 24 weeks in drug-naïve patients with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise. Six hundred seventy-six treated patients received placebo (n=228), JARDIANCE 10 mg (n=224), or JARDIANCE 25 mg (n=224). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.1

Add-on to metformin trial design:

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.

 

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

SBP reductions when using as monotherapy and add-on to metformin

In addition, JARDIANCE reduced SBP as early as 24 weeks in 2 placebo-controlled, glucose-lowering studies of JARDIANCE as monotherapy and as add-on to metformin.*

 

T2D efficacy SBP reductions

* JARDIANCE is not indicated for SBP reduction. SBP reduction was a secondary endpoint.

  • † Placebo-corrected mean changes of -2.6 mmHg from a baseline of 133 mmHg for JARDIANCE 10 mg (P=0.0231) and -3.4 mmHg from a baseline of 129.9 mmHg for JARDIANCE 25 mg (P=0.0028).3
  • ‡ 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.2

  

Open

Monotherapy trial design:

A Phase III, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study of JARDIANCE administered orally once daily over 24 weeks in treatment-naïve patients with type 2 diabetes mellitus with insufficient glycemic control. A total of 676 treated patients received placebo (n=228), JARDIANCE 10 mg (n=224), or JARDIANCE 25 mg (n=224). The primary endpoint was A1C change from baseline. Weight change and blood pressure change from baseline were secondary endpoints.1

Add-on to metformin trial design:

A Phase III, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of JARDIANCE 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

  • mmHg=millimeter of mercury; SBP=systolic blood pressure.

Choose JARDIANCE—proven to help adult patients across four indications

JARDIANCE is indicated for:

Kidney

Adults with chronic kidney disease

Reduction in risk of sustained eGFR decline, ESKD, CV death, and hospitalization

Kidney

Adults with heart failure

Reduction in risk of CV death and hHF

Kidney

Adults with T2D and eCVD

Reduction in risk of CV death

Kidney

Adults with T2D

Improvement of glycemic control along with diet and exercise

Major guideline recommendations support the use of SGLT2is like JARDIANCE for appropriate patients5-8

JARDIANCE is not recommended:

  • for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase their risk of diabetic ketoacidosis.
  • for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.
  • for the treatment of CKD in patients with polycystic kidney disease or patients requiring or with a recent history of IV immunosuppressive therapy or >45 mg of prednisone or equivalent for kidney disease. JARDIANCE is not expected to be effective in these populations.
  • CV=cardiovascular; eCVD=established cardiovascular disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; hHF=hospitalization for heart failure; IV=intravenous; SGLT2i=sodium-glucose cotransporter-2 inhibitor; T2D=type 2 diabetes.

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INDICATIONS AND LIMITATIONS OF USE

JARDIANCE is indicated:

  • to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure
  • to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression
  • to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease
  • as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus

JARDIANCE is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase their risk of diabetic ketoacidosis.

JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR <30 mL/min/1.73 m2. JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action.

JARDIANCE is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease. JARDIANCE is not expected to be effective in these populations.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS: Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred.

WARNINGS AND PRECAUTIONS

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis: JARDIANCE increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes and fatal ketoacidosis has occurred with JARDIANCE. Type 2 diabetes and pancreatic disorders are also risk factors for ketoacidosis and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using JARDIANCE. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse. Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Assess patients who present with signs and symptoms of metabolic ketoacidosis, regardless of blood glucose levels. If suspected, discontinue JARDIANCE, treat promptly and monitor for resolution before restarting. Consider ketone monitoring in patients with type 1 diabetes mellitus as well as in others at risk for ketoacidosis. Withhold JARDIANCE in clinical situations known to predispose to ketoacidosis and resume when clinically stable. Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue JARDIANCE and seek medical attention immediately if signs and symptoms occur.

Volume Depletion: JARDIANCE can cause intravascular volume depletion which may manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors, including JARDIANCE. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR <60 mL/min/1.73 m2), elderly patients or patients on loop diuretics. In patients with volume depletion, correct this condition before initiating JARDIANCE. After initiating, monitor for signs and symptoms of volume depletion and renal function.

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

Hypoglycemia: In adult patients, the use of JARDIANCE in combination with insulin or insulin secretagogues can increase the risk of hypoglycemia. In pediatric patients aged 10 years and older, the risk of hypoglycemia was higher with JARDIANCE regardless of insulin use. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin.

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Serious, life-threatening cases requiring urgent surgical intervention have occurred in both females and males receiving JARDIANCE. 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: JARDIANCE increases the risk for genital mycotic infections, especially in patients with prior infections. Monitor and treat as appropriate.

Lower Limb Amputation: Lower limb amputations have been observed in patients with chronic kidney disease taking JARDIANCE. Peripheral artery disease, and diabetic foot infection (including osteomyelitis), were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of diabetic foot, peripheral artery disease (including previous amputation) or diabetes. Counsel patients receiving JARDIANCE about the importance of routine preventative foot care and monitor for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment.

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.

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

DRUG INTERACTIONS:

Diuretics: Coadministration with diuretics may enhance the potential for volume depletion. Monitor for signs and symptoms.
Lithium: Concomitant use with lithium may decrease serum lithium concentrations. Monitor more frequently during JARDIANCE initiation and dosage changes.

USE IN SPECIAL POPULATIONS

Pregnancy: JARDIANCE is not recommended during the second and third trimesters.
Lactation: JARDIANCE is not recommended while breastfeeding.
Geriatric Use: JARDIANCE is expected to have diminished glycemic efficacy in elderly patients with renal impairment. Assess renal function more frequently in elderly patients. The incidence of volume depletion-related adverse reactions and urinary tract infections increased in T2D patients ≥75 years treated with empagliflozin.

CL-JAR-100162 09.21.2023

For more information, please see Prescribing Information, and Medication Guide.

References

  1. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc.

  2. Häring HU, Merker L, Seewaldt-Becker E, et al; EMPA-REG MET Trial Investigators. Empagliflozin as add-on to metformin in patients with type 2 diabetes: a 24-week, randomized, double-blind, placebo-controlled trial. Diabetes Care. 2014;37(6):1650-1679.

  3. Roden M, Weng J, Eilbracht J, et al; EMPA-REG MONO Trial Investigators. Empagliflozin monotherapy with sitagliptin as an active comparator in patients with type 2 diabetes: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2013;1(3):208-219.

  4. Roden M, Merker L, Christiansen AV, et al. Safety, tolerability and effects on cardiometabolic risk factors of empagliflozin monotherapy in drug naïve patients with type 2 diabetes: a double blind extension of a phase III randomized controlled trial. Cardiovasc Diabetol. 2015;(14):154.

  5. American Diabetes Association. Standards of medical care in diabetes—2023. Diabetes Care. 2023;46(suppl 1):S1-S291.

  6. Blonde L, Umpierrez GE, Reddy SS, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: developing a diabetes mellitus comprehensive care plan—2022 update. Endocr Pract. 2022;28:923-1049.

  7. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. KDIGO 2022 clinical practice guideline for diabetes management in chronic kidney disease. Kidney Int. 2022;102(55):S1-S127.

  8. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022;145:e895-e1032.