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What is Tradjenta (linagliptin)?
Tradjenta (linagliptin) is an oral diabetes medicine that is combined with diet and exercise to improve blood glucose levels in patients with type 2 diabetes. It should not be used for treating type 1 diabetes or diabetic ketoacidosis because it would not be effective in these conditions.
Common side effects of Tradjenta include:
- stuffy or runny nose,
- sore throat,
- allergic reactions,
- muscle pain,
- increased uric acid levels, and
Serious side effects of Tradjenta include:
Other drugs that increase activity CYP3A4 may also reduce the blood concentration of Tradjenta.
What are the side effects of Tradjenta (linagliptin)?
The most common side effects of Tradjenta are:
- Stuffy or runny nose
- Sore throat
- Allergic reactions
- Muscle pain
- Increased uric acid levels
Hypoglycemia may occur when Tradjenta is combined with insulin or a sulfonylurea-type drug.
Possible serious side effects include:
- Severe joint pain
- Severe allergic reactions (anaphalaxis)
Tradjenta (linagliptin) side effects list for healthcare professionals
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety evaluation of Tradjenta 5 mg once daily in patients with type 2 diabetes is based on 14 placebo-controlled trials, 1 active-controlled study, and one study in patients with severe renal impairment. In the 14 placebo-controlled studies, a total of 3625 patients were randomized and treated with Tradjenta 5 mg daily and 2176 with placebo. The mean exposure in patients treated with Tradjenta across studies was 29.6 weeks. The maximum follow-up was 78 weeks.
Tradjenta 5 mg once daily was studied as monotherapy in three placebo-controlled trials of 18 and 24 weeks’ duration and in five additional placebo-controlled studies lasting ≤18 weeks. The use of Tradjenta in combination with other antihyperglycemic agents was studied in six placebo-controlled trials: two with metformin (12 and 24 weeks’ treatment duration); one with a sulfonylurea (18 weeks’ treatment duration); one with metformin and sulfonylurea (24 weeks’ treatment duration); one with pioglitazone (24 weeks’ treatment duration); and one with insulin (primary endpoint at 24 weeks).
In a pooled dataset of 14 placebo-controlled clinical trials, adverse reactions that occurred in ≥2% of patients receiving Tradjenta (n = 3625) and more commonly than in patients given placebo (n = 2176), are shown in Table 1. The overall incidence of adverse events with Tradjenta were similar to placebo.
Table 1: Adverse Reactions Reported in ≥2% of Patients Treated with Tradjenta and Greater than Placebo in Placebo-Controlled Clinical Studies of Tradjenta Monotherapy or Combination Therapy
|Number (%) of Patients|
|Tradjenta 5 mg|
n = 3625
n = 2176
|Nasopharyngitis||254 (7.0)||132 (6.1)|
|Diarrhea||119 (3.3)||65 (3.0)|
|Cough||76 (2.1)||30 (1.4)|
Rates for other adverse reactions for Tradjenta 5 mg vs placebo when Tradjenta was used in combination with specific anti-diabetic agents were: urinary tract infection (3.1% vs 0%) and hypertriglyceridemia (2.4% vs 0%) when Tradjenta was used as add-on to sulfonylurea; hyperlipidemia (2.7% vs 0.8%) and weight increased (2.3% vs 0.8%) when Tradjenta was used as add-on to pioglitazone; and constipation (2.1% vs 1%) when Tradjenta was used as add-on to basal insulin therapy.
Following 104 weeks’ treatment in a controlled study comparing Tradjenta with glimepiride in which all patients were also receiving metformin, adverse reactions reported in ≥5% of patients treated with Tradjenta (n = 776) and more frequently than in patients treated with a sulfonylurea (n = 775) were back pain (9.1% vs 8.4%), arthralgia (8.1% vs 6.1%), upper respiratory tract infection (8.0% vs 7.6%), headache (6.4% vs 5.2%), cough (6.1% vs 4.9%), and pain in extremity (5.3% vs 3.9%).
Other adverse reactions reported in clinical studies with treatment of Tradjenta 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 year exposure while being treated with Tradjenta compared with 3.7 cases per 10,000 patient year exposure while being treated with comparator (placebo and active comparator, sulfonylurea). Three additional cases of pancreatitis were reported following the last administered dose of linagliptin.
In the placebo-controlled studies, 199 (6.6%) of the total 2994 patients treated with Tradjenta 5 mg reported hypoglycemia compared to 56 patients (3.6%) of 1546 placebo-treated patients. The incidence of hypoglycemia was similar to placebo when Tradjenta was administered as monotherapy or in combination with metformin, or with pioglitazone.
When Tradjenta was administered in combination with metformin and a sulfonylurea, 181 of 792 (22.9%) patients reported hypoglycemia compared with 39 of 263 (14.8%) patients administered placebo in combination with metformin and a sulfonylurea. Adverse reactions of hypoglycemia were based on all reports of hypoglycemia. A concurrent glucose measurement was not required or was normal in some patients. Therefore, it is not possible to conclusively determine that all these reports reflect true hypoglycemia.
In the study of patients receiving Tradjenta as add-on therapy to a stable dose of insulin for up to 52 weeks (n=1261), no significant difference in the incidence of investigator reported hypoglycemia, defined as all symptomatic or asymptomatic episodes with a self-measured blood glucose ≤70 mg/dL, was noted between the Tradjenta-(31.4%) and placebo-(32.9%) treated groups.
During the same time period, severe hypoglycemic events, defined as requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, were reported in 11 (1.7%) of Tradjenta treated patients and 7 (1.1%) of placebo treated patients. Events that were considered life-threatening or required hospitalization were reported in 3 (0.5%) patients on Tradjenta and 1 (0.2%) on placebo.
Use In Renal Impairment
Tradjenta was compared to placebo as add-on to pre-existing antidiabetic therapy over 52 weeks in 133 patients with severe renal impairment (estimated GFR <30 mL/min). For the initial 12 weeks of the study, background antidiabetic therapy was kept stable and included insulin, sulfonylurea, glinides, and pioglitazone. For the remainder of the trial, dose adjustments in antidiabetic background therapy were allowed.
In general, the incidence of adverse events including severe hypoglycemia was similar to those reported in other Tradjenta trials. The observed incidence of hypoglycemia was higher (Tradjenta, 63% compared to placebo, 49%) due to an increase in asymptomatic hypoglycemic events especially during the first 12 weeks when background glycemic therapies were kept stable.
Ten Tradjenta-treated patients (15%) and 11 placebo-treated patients (17%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying finger stick glucose ≤54 mg/dL). During the same time period, severe hypoglycemic events, defined as an event requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions, were reported in 3 (4.4%) Tradjenta-treated patients and 3 (4.6%) placebo-treated patients. Events that were considered life-threatening or required hospitalization were reported in 2 (2.9%) patients on Tradjenta and 1 (1.5%) patient on placebo.
Renal function as measured by mean eGFR and creatinine clearance did not change over 52 weeks’ treatment compared to placebo.
Changes in laboratory findings were similar in patients treated with Tradjenta 5 mg compared to patients treated with placebo.
Increase in Uric Acid
Changes in laboratory values that occurred more frequently in the Tradjenta group and ≥1% more than in the placebo group were increases in uric acid (1.3% in the placebo group, 2.7% in the Tradjenta group).
Increase in Lipase
In a placebo-controlled clinical trial with Tradjenta in type 2 diabetes mellitus patients with micro-or macroalbuminuria, a mean increase of 30% in lipase concentrations from baseline to 24 weeks was observed in the Tradjenta arm compared to a mean decrease of 2% in the placebo arm. Lipase levels above 3 times upper limit of normal were seen in 8.2% compared to 1.7% patients in the Tradjenta and placebo arms, respectively.
No clinically meaningful changes in vital signs were observed in patients treated with Tradjenta.
Additional adverse reactions have been identified during postapproval use of Tradjenta. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
What drugs interact with Tradjenta (linagliptin)?
Inducers Of P-Glycoprotein Or CYP3A4 Enzymes
Rifampin decreased linagliptin exposure, suggesting that the efficacy of Tradjenta may be reduced when administered in combination with a strong P-gp or CYP3A4 inducer. Therefore, use of alternative treatments is strongly recommended when linagliptin is to be administered with a strong P-gp or CYP3A4 inducer.
Tradjenta (linagliptin) is an oral diabetes medicine that is combined with diet and exercise to improve blood glucose levels in patients with type 2 diabetes. It should not be used for treating type 1 diabetes or diabetic ketoacidosis because it would not be effective in these conditions. Common side effects of Tradjenta include stuffy or runny nose, sore throat, allergic reactions, muscle pain, diarrhea, increased uric acid levels, and cough. Low blood sugar (hypoglycemia) may occur when Tradjenta is combined with insulin or a sulfonylurea-type drug. Drug interactions of Tradjenta include rifampin, which decreases the blood concentration of Tradjenta by stimulating breakdown of Tradjenta by CYP3A4 liver enzymes. There are no adequate studies of Tradjenta in pregnant women. It is unknown if Tradjenta is secreted in human breast milk. Consult your doctor before breastfeeding.
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People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
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A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
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Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Type 1 vs. Type 2 Diabetes: Differences
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Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.