IN ADDITION TO DIET AND EXERCISE, TO IMPROVE GLYCEMIC CONTROL IN ADULT PATIENTS WITH TYPE 2 DIABETES. NOT FOR TYPE 1 DIABETES OR DIABETIC KETOACIDOSIS.

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Efficacy

Monotherapy and Add-On Studies

 
 

As monotherapy and as add-on therapy to metformin, metformin and a sulfonylurea (SU), and basal insulin1-5*

Primary endpoint: Placebo-adjusted mean difference in A1C at 24 weeks

A1C Reduction Chart – Monotherapy and Add-on Therapy

TRADJENTA was also studied as an initial combination with pioglitazone. Baseline A1C=8.6%; placebo-adjusted mean difference in A1C at 24 weeks=--0.5% (n=252, CI95%[-0.7,-0.3])1† ††

 

Add-on to Basal Insulin

 
 

As add-on therapy to basal insulin, TRADJENTA provided statistically significant A1C reduction1,2*

With incidence of hypoglycemia similar to placebo


Primary endpoint result: –0.7% placebo-adjusted mean difference in A1C at 24 weeks; TRADJENTA n=618; (FAS [LOCF]; P<0.0001)*

Safety endpoint: Incidence of investigator-reported hypoglycemia1,2†

Incidence of Hypoglycemia vs Placebo Chart, As Add-On to Basal Insulin
Study Designs
Severe Hypoglycemic Events at 52 Weeks 
TRADJENTA
n(%)
Placebo
n(%)
11 (1.7%)
7 (1.1%)
Mean change from baseline in the daily dose of basal insulin1§‖
  • +0.1 IU for TRADJENTA and +0.4 IU for placebo at 24 weeks
  • +2.5 IU for TRADJENTA and +4.1 IU for placebo at 52 weeks

Study Designs

2-year Noninferiority Study VS. an SU

 
 

In a 2-year noninferiority study, efficacy comparable to glimepiride in patients receiving metformin ≥1500 mg/day
with a lower incidence of hypoglycemia and comparative weight difference1,2*

Primary endpoint result: A1C reduction was demonstrated to be noninferior compared with glimepiride (1-sided noninferiority; P=0.0004). Patients in the FAS (LOCF) population achieved an adjusted mean A1C reduction of 0.2% (n=764) from baseline at 104 weeks vs an adjusted A1C mean reduction of 0.4% with glimepiride (n=755)

A conclusion in favor of the noninferiority of TRADJENTA to glimepiride may be limited to patients with a baseline A1C comparable to those included in the study (66% of patients had baseline A1C <8% and 91% had A1C <9%)

Primary endpoint: Adjusted mean difference in A1C between linagliptin and glimepiride at 104 weeks1*

A1C Reduction Linagliptin vs. Glimepiride Graph, As Add-On to Metformin
Study Designs

Secondary endpoint: Incidence of hypoglycemia1†

Incidence of Hypoglycemia - Tradjenta vs Glimepiride, As Add-On to Metformin
Study Designs

Secondary endpoint: Adjusted mean body weight (lb) change from baseline over 104 weeks §

Mean Body Weight Change - Tradjenta vs Glimepiride, As Add-On to Metformin
Study Designs
 
  • Patients treated with TRADJENTA were observed to have an adjusted mean decrease in body weight from baseline of 1.4 kg, whereas patients on glimepiride had an adjusted mean increase in body weight of 1.3 kg at 104 weeks, resulting in a comparative weight difference (linagliptin minus glimepiride) of 2.7 kg between the 2 treatment arms.

Data in Adult Patients with Type 2 Diabetes and Severe Renal Impairment

 
 

Statistically significant A1C reductions in adult patients with type 2 diabetes and severe renal impairment1,2*

Placebo-adjusted mean difference in A1C

Chart: Placebo-adjusted mean difference in A1C
Chart: Placebo-adjusted mean difference in A1C
Study Designs  

Efficacy

 
 

As monotherapy and as add-on therapy to metformin, metformin and a sulfonylurea (SU), and basal insulin1-5*

Primary endpoint: Placebo-adjusted mean difference in A1C at 24 weeks

A1C Reduction Chart – Monotherapy and Add-on Therapy

TRADJENTA was also studied as an initial combination with pioglitazone. Baseline A1C=8.6%; placebo-adjusted mean difference in A1C at 24 weeks=--0.5% (n=252, CI95%[-0.7,-0.3])1† ††

 
 
 

As add-on therapy to basal insulin, TRADJENTA provided statistically significant A1C reduction1,2*

With incidence of hypoglycemia similar to placebo


Primary endpoint result: –0.7% placebo-adjusted mean difference in A1C at 24 weeks; TRADJENTA n=618; (FAS [LOCF]; P<0.0001)*

Safety endpoint: Incidence of investigator-reported hypoglycemia1,2†

Incidence of Hypoglycemia vs Placebo Chart, As Add-On to Basal Insulin
Study Designs
Severe Hypoglycemic Events at 52 Weeks 
TRADJENTA
n(%)
Placebo
n(%)
11 (1.7%)
7 (1.1%)
Mean change from baseline in the daily dose of basal insulin1§‖
  • +0.1 IU for TRADJENTA and +0.4 IU for placebo at 24 weeks
  • +2.5 IU for TRADJENTA and +4.1 IU for placebo at 52 weeks

Study Designs

 
 

In a 2-year noninferiority study, efficacy comparable to glimepiride in patients receiving metformin ≥1500 mg/day
with a lower incidence of hypoglycemia and comparative weight difference1,2*

Primary endpoint result: A1C reduction was demonstrated to be noninferior compared with glimepiride (1-sided noninferiority; P=0.0004). Patients in the FAS (LOCF) population achieved an adjusted mean A1C reduction of 0.2% (n=764) from baseline at 104 weeks vs an adjusted A1C mean reduction of 0.4% with glimepiride (n=755)

A conclusion in favor of the noninferiority of TRADJENTA to glimepiride may be limited to patients with a baseline A1C comparable to those included in the study (66% of patients had baseline A1C <8% and 91% had A1C <9%)

Primary endpoint: Adjusted mean difference in A1C between linagliptin and glimepiride at 104 weeks1*

A1C Reduction Linagliptin vs. Glimepiride Graph, As Add-On to Metformin
Study Designs

Secondary endpoint: Incidence of hypoglycemia1†

Incidence of Hypoglycemia - Tradjenta vs Glimepiride, As Add-On to Metformin
Study Designs

Secondary endpoint: Adjusted mean body weight (lb) change from baseline over 104 weeks §

Mean Body Weight Change - Tradjenta vs Glimepiride, As Add-On to Metformin
Study Designs
 
  • Patients treated with TRADJENTA were observed to have an adjusted mean decrease in body weight from baseline of 1.4 kg, whereas patients on glimepiride had an adjusted mean increase in body weight of 1.3 kg at 104 weeks, resulting in a comparative weight difference (linagliptin minus glimepiride) of 2.7 kg between the 2 treatment arms.
 
 

Statistically significant A1C reductions in adult patients with type 2 diabetes and severe renal impairment1,2*

Placebo-adjusted mean difference in A1C

Chart: Placebo-adjusted mean difference in A1C
Chart: Placebo-adjusted mean difference in A1C
Study Designs  

DOSING

The only single-strength DPP-4i* with no dose adjustment, regardless of renal function

Dosing and Renal Function
Dosing and Renal Function
*One 5-mg tablet, once daily for adult patients with type 2 diabetes.
Refers to categories of renal impairment.
Primarily nonrenal excretion with 5% elimination via the kidney and 80% excreted via the bile and gut within 4 days of dosing.
When TRADJENTA is used in combination with an insulin secretagogue (eg, sulfonylurea) or insulin, a lower dose of the insulin secretagogue or insulin may be required to reduce the risk of hypoglycemia.

TRADJENTA SAFETY PROFILE

Demonstrated safety profile evaluated in more than 6000 patients

Adverse Reactions Table
Adverse Reactions Table
  • Other adverse reactions reported in clinical studies with treatment of TRADJENTA tablets were hypersensitivity (e.g., urticaria, angioedema, localized skin exfoliation, or bronchial hyperreactivity) and myalgia.
  • In the clinical trial program, pancreatitis was reported in 15.2 cases per 10,000 patient-years of exposure while being treated with TRADJENTA compared with 3.7 cases per 10,000 patient-years of exposure while being treated with comparator (placebo and active comparator, sulfonylurea [SU]). Three additional cases of pancreatitis were reported following the last administered dose of linagliptin.
  • In the placebo-controlled studies, hypoglycemia was reported in 6.6% of patients treated with linagliptin vs 3.6% of patients treated with placebo. When linagliptin was administered in combination with metformin and an SU, 22.9% of patients reported hypoglycemia vs 14.8% of patients administered placebo in combination with metformin and an SU.
  • In the study of patients receiving TRADJENTA as add-on therapy to a stable dose of insulin for up to 52 weeks, no significant difference in the incidence of investigator-reported hypoglycemia was noted compared with placebo (31.4% vs 32.9%, respectively). The incidence of hypoglycemia was also similar in both groups (21.4% TRADJENTA; 22.9% placebo) in the first 24 weeks of the study. At 52 weeks, severe hypoglycemic events were reported in 11 (1.7%) TRADJENTA patients compared with 7 (1.1%) for placebo.
  • In a study of TRADJENTA as add-on to pre-existing antidiabetic therapy in patients with severe renal impairment, the incidence of hypoglycemia was higher in patients treated with linagliptin (63%) vs patients treated with placebo (49%). Severe hypoglycemic events were reported in 4.4% of patients treated with linagliptin vs 4.6% of patients treated with placebo in this trial.
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INDICATION AND IMPORTANT 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.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRADJENTA is contraindicated in patients with a history of hypersensitivity reaction to linagliptin, such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity.

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.

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 (e.g., sulfonylurea) increases the risk of hypoglycemia. A lower dose of insulin or insulin secretagogue may be required.

Hypersensitivity Reactions

Serious hypersensitivity reactions have been reported in patients treated with TRADJENTA including anaphylaxis, angioedema, and exfoliative skin conditions. Onset of these reactions occurred within the first 3 months after initiation of treatment, with some occurring after the first dose. If a serious hypersensitivity reaction is suspected, discontinue, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other DPP-4 inhibitors. 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 linagliptin 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 in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue TRADJENTA.

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with 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-100001 8.21.17

Please see Prescribing Information and Medication Guide.