In the 18-week study, 76 patients were randomized to placebo and 151 to TRADJENTA 5 mg; in the 24-week study, 167 patients were randomized to placebo and 336 to TRADJENTA 5 mg. These doses represent approximately 943 times (rats) and 1943 times (rabbits) the 5 mg clinical dose, based on exposure. Participants with an estimated (based on the four variables modified diet in renal disease [MDRD] equation) GFR value of <30 mL/min were eligible to participate in the study. Therapy was stopped in patients on oral antihyperglycemic therapy for a period of 6 weeks (4 weeks followed by a 2week, open-label, placebo run-in period).
The use of Tradjenta in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin was associated with a higher rate of hypoglycemia compared with placebo in clinical trials There have been postmarketing reports of serious hypersensitivity reactions in patients treated with Tradjenta. The mean difference between groups in A1C change from baseline was 0.2% with 2-sided 97.5% confidence interval (0.1%, 0.3%) for the intent-to-treat population using last observation carried forward. Ten TRADJENTA-treated patients (15%) and 11 placebo-treated patients (17%) reported at least one episode of confirmed symptomatic hypoglycemia (accompanying 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.Changes in laboratory values that occurred more frequently in the TRADJENTA group and ≥1% more than in the placebo group were increases in In a placebo-controlled clinical trial with TRADJENTA in type 2 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. Instruct patients to seek medical advice if severe joint pain occurs Inform patients that bullous pemphigoid has been reported during use of Tradjenta. Patients who failed to meet specific glycemic goals during the studies were treated with metformin rescue. The trial compared the risk of major adverse cardiovascular events (MACE) between Tradjenta and placebo when these were added to standard of care treatments for diabetes and other cardiovascular risk factors. As is typical for trials of agents to treat type 2 diabetes, the mean reduction in A1C with Tradjenta appears to be related to the degree of A1C elevation at baseline.
Do not use TRADJENTA for a condition for which it was not prescribed. Three additional cases of pancreatitis were reported following the last administered dose of linagliptin.Table 2 summarizes the incidence of hypoglycemia in placebo-controlled studies of Tradjenta. In patients with moderate hepatic impairment (Child-Pugh class B), AUCss of linagliptin was about 14% lower and Cmax,ss was approximately 8% lower than in healthy subjects. Your body can also make too much sugar. Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.
For some people, it may also be used to lower the risk of heart attack, stroke, or death. The Kaplan-Meier curve depicting time to first occurrence of MACE is shown in Figure 1.The cardiovascular risk of Tradjenta was evaluated in CAROLINA, a multi-center, multi-national, randomized, double-blind, parallel group trial comparing Tradjenta (N=3023) to glimepiride (N=3010) in adult patients with type 2 diabetes mellitus and a history of established cardiovascular disease and/or multiple cardiovascular risk factors. For the initial 12 weeks of the study, background antidiabetic therapy was kept stable and included insulin, sulfonylurea, glinides, and pioglitazone. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity.No adverse developmental outcome was observed when linagliptin was administered to pregnant Wistar Han rats and Himalayan rabbits during the period of organogenesis at doses up to 240 mg/kg and 150 mg/kg, respectively. These reactions include Angioedema has also been reported with other dipeptidyl There have been postmarketing reports of severe and disabling There have been no clinical studies establishing conclusive evidence of Advise the patient to read the FDA-approved patient labeling (Instruct patients to read the Medication Guide before starting TRADJENTA therapy and to reread it each time the prescription is renewed. These results were consistent with the completers analysis.Patients treated with linagliptin had a mean baseline body weight of 86 kg and were observed to have an adjusted mean decrease in body weight of 1.1 kg at 52 weeks and 1.4 kg at 104 weeks.
The time to onset of symptoms following initiation of drug therapy varied from one day to years. In the CARMELINA trial Bullous pemphigoid was reported in 7 (0.2%) patients treated with Tradjenta compared to none in patients treated with placebo in the CARMELINA trial Disease-associated maternal and/or embryo/fetal riskActive-Controlled Study vs Glimepiride in Combination with MetforminAdd-On Combination Therapy with Metformin and a SulfonylureaFigure 1 Kaplan-Meier: Time to First Occurrence of MACE in the CARMELINA TrialFigure 2 Time to First Occurrence of 3P-MACE in CAROLINAWhat should I tell my doctor before taking Tradjenta?Keep Tradjenta and all medicines out of the reach of children.General information about the safe and effective use of Tradjenta.We comply with the HONcode standard for trustworthy health information -