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.
TRADJENTA SAFETY PROFILE
Demonstrated safety profile evaluated in more than 6000 patients
- Other adverse reactions reported in clinical trials with treatment of TRADJENTA tablets were hypersensitivity (eg, 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 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%) due to an increase in asymptomatic hypoglycemic events especially during the first 12 weeks when background glycemic therapies (insulin, sulfonylurea, glinides and pioglitazone) were kept stable. Severe hypoglycemic events were reported in 4.4% of patients treated with linagliptin vs 4.6% of patients treated with placebo in this trial.