official website and that any information you provide is encrypted In the CARMELINA trial [see Clinical Studies (14)], acute pancreatitis was reported in 9 (0.3%) patients treated with TRADJENTA and in 5 (0.1%) patients treated with placebo. Randomization was stratified by baseline A1C (<8.5% vs 8.5%) and use of a prior oral antidiabetic drug (none vs monotherapy). Labels, All Index Uses Warnings Before taking Side effects Dosage Interactions What is linagliptin? Linagliptin is associated with only moderate reductions in HbA1c (by 0.4% and 0.69% in pivotal clinical studies)6,19 and is more suitable as add-on combination therapy than as single-agent treatment. Glycemic endpoints measured were A1C and FPG. Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors. ), More about getting RSS News & Updates from DailyMed. In the TRADJENTA treatment arm of the CARMELINA trial [see Clinical Studies (14)], 2200 (63%) patients had renal impairment (eGFR <60 mL/min/1.73 m2). The labeling for linagliptin also includes data from a 24-week, randomized, double-blind, placebo-controlled study of linagliptin in combination with a sulfonylurea and metformin in patients with type-2 diabetes.6 The most commonly used sulfonylureas were glimepiride, 31%; glibenclamide, also known as glyburide (Micronase, Pfizer), 26%; and gliclazide (not available in the U.S.), 26%. However, the dose is usually not more than 25 mg of empagliflozin and 5 mg of linagliptin per day. The half-life of the metabolite was 10.8 hours. The results of CARMELINA, including the contribution of each component to the primary composite endpoint, are shown in Table 13. TRADJENTA has not been studied in patients with a history of pancreatitis. In fertility studies in rats, linagliptin had no adverse effects on early embryonic development, mating, fertility, or bearing live young up to the highest dose of 240 mg/kg (approximately 943-times the clinical dose based on AUC exposure). Assessment of the pharmacokinetic interaction between the novel DPP-4 inhibitor linagliptin and a sulfonylurea, glyburide, in healthy subjects. Figure 1 Kaplan-Meier: Time to First Occurrence of MACE in the CARMELINA Trial. Additional clinical trials are needed to further delineate the clinical profile of linagliptin in combination therapy. being able to get an erection, but not having it last long enough for sex. A randomized, placebo-controlled phase 3 study evaluated the effect of linagliptin monotherapy on glycemic control and on markers of beta-cell function in patients with inadequately controlled type-2 diabetes.19 A total of 503 patients were randomly assigned to linagliptin 5 mg (n = 336) or placebo (n = 167) once daily. 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. All rights reserved. Acute pancreatitis, including fatal pancreatitis, has been reported in patients treated with TRADJENTA. 0597-0140-70, In combination with a sulfonylurea, linagliptin provided a statistically significant improvement from baseline in HbA1c levels, compared with placebo and a sulfonylurea at 18 weeks (adjusted means, 0.5% vs. 0.1%, respectively; P value not stated). Patients on an antihyperglycemic agent (52%) underwent a drug washout period of 4 weeks' duration. Citations, 5.2 Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues, 7.1 Inducers of P-glycoprotein or CYP3A4 Enzymes, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20% to 25% in women with HbA1c >10. government site. Linagliptin, a new DPP-4 inhibitor, offers another option for the treatment of inadequately controlled type-2 diabetes in patients who are already receiving metformin or a sulfonylurea. Placebo-corrected mean changes in fasting plasma glucose for the three linagliptin doses were 1.1 mmol/L (P = 0.002), 1.9 mmol/L (P < 0.0001), and 1.6 mmol/L (P = 0.0001), respectively.21, The incidence of AEs was similar for all treatment groups. Table 1 presents a comparison of the pharmacokinetic characteristics of the three available DPP-4 inhibitors.68,18, Key Pharmacokinetic Characteristics of the DPP-4 Inhibitors. TRADJENTA may be administered with or without food. The trial population included 17% patients 75 years of age and 62% patients with renal impairment defined as eGFR <60 mL/min/1.73 m2. The primary endpoint was the change from baseline in HbA1c after 24 weeks of treatment. Ring A, Port A, Graefe-Mody EU, et al. View NDC Code(s)NEW! Patients with a baseline A1C of 7% and 10% were included in the study including 709 patients with renal impairment (eGFR <90 mL/min), most of whom (n=575) were categorized as mild renal impairment (eGFR 60 to <90 mL/min). Therapy was stopped in patients on oral antihyperglycemic therapy for a period of 6 weeks (4 weeks followed by a 2-week, open-label, placebo run-in period). 1 INDICATIONS AND USAGE TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Files, Presentations Coadministration of TRADJENTA with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia [see Warnings and Precautions (5.2)]. The usual dose is 5mg a day. Patients experienced relief of symptoms upon discontinuation of the medication. Disease-associated maternal and/or embryo/fetal risk. Plasma AUC of linagliptin increased in a less than dose-proportional manner in the dose range of 1 to 10 mg. Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the CARMELINA and CAROLINA trademarks under license. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Tradjenta is an oral diabetes medicine that helps control blood sugar levels. Patients were eligible to enter the trial if they were adults with type 2 diabetes, with HbA1c of 6.5% to 10%, and had either albuminuria and previous macrovascular disease (39% of enrolled population), or evidence of impaired renal function by eGFR and Urinary Albumin Creatinine Ratio (UACR) criteria (42% of enrolled population), or both (18% of enrolled population). In these 18- and 24-week studies, the changes from baseline in A1C were -0.4% and -0.4%, respectively, for those given TRADJENTA, and 0.1% and 0.3%, respectively, for those given placebo. A total of 730 patients with type 2 diabetes participated in 2 double-blind, placebo-controlled studies, one of 18 weeks' and another of 24 weeks' duration, to evaluate the efficacy and safety of TRADJENTA monotherapy. If you have had pancreatitis in the past, it is not known if you have a higher chance of getting pancreatitis while you take TRADJENTA. Side effects that you should report to your care team as soon as possible: Allergic reactionsskin rash, itching, hives, swelling of the face, lips, tongue, or throat. symptoms of heart failure --shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain. Sarashina A, Sesoko S, Nakashima M, et al. Take TRADJENTA exactly as your healthcare provider tells you to take it. No increase in QTc was observed with either the recommended dose of 5 mg or the 100 mg dose. Dosage form: oral tablet (5 mg) Drug class: Dipeptidyl peptidase 4 inhibitors Medically reviewed by Drugs.com on Mar 27, 2023. ***18-week study. being unable to get an erection at any time. A single dose of oral linagliptin ranging from 2.5 to 600 mg/day produced different t max values, from 0.7 to 3 h, . Patients with severe hepatic impairment (Child-Pugh class C) had comparable exposure of linagliptin in terms of AUC0-24 and approximately 23% lower Cmax compared with healthy subjects. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of B1 1356, an inhibitor of dipeptidyl peptidase 4, in healthy male volunteers. Randomization was stratified by baseline HbA1c (<8.5% vs 8.5%), and the previous use of antidiabetic drugs (metformin alone vs metformin plus one other OAD). Efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type-2 diabetes: A randomized, double-blind, placebo-controlled study. Reductions in the pharmacokinetic parameters seen in patients with hepatic impairment did not result in reductions in DPP-4 inhibition. Sign up for free and stay up to date on research advancements, health tips, current health topics, and expertise on managing health. 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. Del Prato S, Barnett AH, Huisman H, et al. Copy the URL below and paste it into your RSS Reader application. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. Review of the safety and efficacy of linagliptin as add-on therapy to metformin in patients with type-2 diabetes: A randomized, double-blind, placebo-controlled study. No adverse functional, behavioral, or reproductive outcome was observed in offspring following administration of linagliptin to Wistar Han rats from gestation day 6 to lactation day 21 at a dose 49-times the maximum recommended human dose, based on exposure. Executive summary: Standards of medical care in diabetes, 2011. See the end of this Medication Guide for a complete list of ingredients in TRADJENTA. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. The pharmacokinetics of linagliptin is similar in healthy subjects and in patients with type 2 diabetes. Linagliptin doses of 1 mg, 5 mg, and 10 mg provided mean, placebo-corrected reductions in HbA1c of 0.40% (P = 0.01 vs. placebo), 0.73% (P < 0.0001), and 0.67% (P < 0.0001), respectively. Warnings Linagliptin is used together with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. conducted a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of initial combination therapy with linagliptin and pioglitazone in patients with inadequately controlled type-2 diabetes.23 A total of 707 patients were assigned to receive linagliptin 5 mg plus pioglitazone 30 mg once daily (n = 259) or placebo plus pioglitazone 30 mg once daily (n = 130). If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of TRADJENTA. ***Hypoglycemic incidence included both asymptomatic events (not accompanied by typical symptoms and plasma glucose concentration of 70 mg/dL) and symptomatic events with typical symptoms of hypoglycemia and plasma glucose concentration of 70 mg/dL. GLP-1 and GIP are involved in the physiological regulation of glucose homeostasis. Patients who failed to meet specific glycemic goals during the study were treated with pioglitazone rescue. View Labeling Archives, Boehringer Ingelheim Promeco, S.A. de C.V. 29 Linagliptin-metformin oral tablet is used along with diet and exercise to improve control of blood sugar levels in adults with type 2 diabetes. the unsubscribe link in the e-mail. For the remainder of the trial, dose adjustments in antidiabetic background therapy were allowed. 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