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CVOT Results

CARMELINA® CV Outcome Trial Result

TRADJENTA was evaluated for CV safety in a 2-year long CARMELINA® CV Outcome Trial1

CARMELINA Trial, Logo
the first DPP-4i CV safety trial with nearly 7000 adult patients with type 2 diabetes and established CV disease and/or renal disease
Proportion of Adults Studied in CVOT, Icon

Proportion of adult patients studied:

  • Elderly* (57%)
  • Established CV disease (57%)
  • Prevalent kidney disease (74%)
  • Established CV and prevalent kidney disease (33%)
Primary Composite Outcome in CVOT, Icon

Primary composite outcome was defined as the time to first occurrence of 3P-MACE:

  • CV death
  • Nonfatal MI
  • Nonfatal stroke

TRADJENTA is not indicated for reduction in 3P-MACE.

TRADJENTA demonstrated CV safety with noninferiority to placebo for 3P-MACE

Primary endpoint: Time to 3P-MACE

Safety Data from a CVOT
med_vector
TRADJENTA was noninferior to placebo for CV events in adult patients with type 2 diabetes and established CV disease and/or renal disease

(HR=1.02 [95% CI: 0.89-1.17]; P<.0.001 for noninferiority)

CARMELINA® Adverse Events

Adverse events occurred in 2697 (77.2%) and 2723 (78.1%) patients in the linagliptin and placebo groups; 1036 (29.7%) and 1024 (29.4%) had 1 or more episodes of hypoglycemia; and there were 9 (0.3%) vs 5 (0.1%) events of adjudication-confirmed acute pancreatitis.

CARMELINA® Trial Design

Randomized, double-blind, placebo-controlled, multicenter, noninferiority trial conducted at 605 clinical sites in 27 countries comparing the use of TRADJENTA administered once daily and placebo with usual care in patients with type 2 diabetes at high risk of CV and/or kidney events. A total of 6979 patients received TRADJENTA 5 mg (N=3494) or placebo (N=3485) and were followed for a median of 2.2 years. The primary endpoint was the reduction in risk of 3P-MACE, defined by the composite of CV death, nonfatal myocardial infarction, or nonfatal stroke.1

*Elderly was defined as patients ≥65 years of age.1

Defined as albuminuria (UACR ≥30 mg/g creatinine or ≥30 μg albumin/min or ≥30 mg albumin/24 h) and previous macrovascular disease (≥1 of the following: confirmed history of myocardial infarction; advanced coronary artery disease; high-risk single-vessel coronary artery disease; history of ischemic or hemorrhagic stroke; presence of carotid artery disease; presence of peripheral artery disease).1

Defined as eGFR <60 mL/min/1.73 m2 and/or UACR >300 mg/g creatinine.1

Reference: 1. Rosenstock J, Perkovic V, Johansen OE, et al; CARMELINA Investigators. Effect of linagliptin vs placebo on major cardiovascular events in adults with type 2 diabetes and high cardiovascular and renal risk: the CARMELINA randomized clinical trial. JAMA. 2019;321(1):69-79.
CI=confidence interval; CV=cardiovascular; eGFR=estimated glomerular filtration rate; HR=hazard ratio; MI=myocardial infarction; 3P-MACE=3-point major adverse cardiovascular event; UACR=urine albumin-to-creatinine ratio.
 

Learn more about the safety profile of TRADJENTA

 

Your eligible commercially insured patients
may pay as little as $10/month*
*See eligibility terms and conditions

Important Safety Information  

CONTRAINDICATIONS: Hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred.

WARNINGS AND PRECAUTIONS

Pancreatitis: Acute pancreatitis, including fatal pancreatitis, has been reported in patients taking TRADJENTA. Take careful notice of potential signs and symptoms of pancreatitis and, if suspected, promptly discontinue and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using TRADJENTA.

Indication and Limitations of Use  

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

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

TRADJENTA has not been studied in patients with a history of pancreatitis, and it is unknown if using TRADJENTA increases the risk of developing pancreatitis in these patients.

Heart Failure: Heart failure has been observed with two other members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Consider the risks and benefits of TRADJENTA in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment. Monitor patients for signs and symptoms. Advise patients of the symptoms of heart failure and to immediately report such symptoms. If heart failure develops consider discontinuation of TRADJENTA.

Use with Medications Known to Cause Hypoglycemia: The use in combination with insulin or insulin secretagogues increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions: Discontinue TRADJENTA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with TRADJENTA.

Severe and Disabling Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider TRADJENTA as a possible cause for severe joint pain and/or disabling arthralgia and discontinue, if appropriate.

Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

MOST COMMON ADVERSE REACTIONS (≥5%): Nasopharyngitis, hypoglycemia (when used in combination with sulfonylurea)

DRUG INTERACTIONS: The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Alternative treatments should be used.

USE IN SPECIFIC POPULATIONS: Use during pregnancy only if clearly needed. Exercise caution when administering to a nursing woman.

CL-TJ-100049 03.30.2020

Please see Prescribing Information and Medication Guide.

Reference: 1. Bailey RA, Wang Y, Zhu V, Rupnow MF. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7:415.

 

Important Safety Information  

CONTRAINDICATIONS: Hypersensitivity to linagliptin or any of the excipients in TRADJENTA, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred.

WARNINGS AND PRECAUTIONS

Pancreatitis: Acute pancreatitis, including fatal pancreatitis, has been reported in patients taking TRADJENTA. Take careful notice of potential signs and symptoms of pancreatitis and, if suspected, promptly discontinue and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using TRADJENTA.

Indication and Limitations of Use  

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

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

TRADJENTA has not been studied in patients with a history of pancreatitis, and it is unknown if using TRADJENTA increases the risk of developing pancreatitis in these patients.

Heart Failure: Heart failure has been observed with two other members of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Consider the risks and benefits of TRADJENTA in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment. Monitor patients for signs and symptoms. Advise patients of the symptoms of heart failure and to immediately report such symptoms. If heart failure develops consider discontinuation of TRADJENTA.

Use with Medications Known to Cause Hypoglycemia: The use in combination with insulin or insulin secretagogues increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions: Discontinue TRADJENTA, assess for other potential causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes. Use caution in a patient with a history of angioedema to another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with TRADJENTA.

Severe and Disabling Arthralgia: Severe and disabling arthralgia has been reported in patients taking DPP-4 inhibitors. Consider TRADJENTA as a possible cause for severe joint pain and/or disabling arthralgia and discontinue, if appropriate.

Bullous Pemphigoid: There have been reports of bullous pemphigoid requiring hospitalization. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

MOST COMMON ADVERSE REACTIONS (≥5%): Nasopharyngitis, hypoglycemia (when used in combination with sulfonylurea)

DRUG INTERACTIONS: The efficacy of TRADJENTA may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Alternative treatments should be used.

USE IN SPECIFIC POPULATIONS: Use during pregnancy only if clearly needed. Exercise caution when administering to a nursing woman.

CL-TJ-100049 03.30.2020

Please see Prescribing Information and Medication Guide.