TRADJENTA is an oral type 2 diabetes medication that can lower your A1C and blood sugar level. Talk to your doctor to see if TRADJENTA is right for you. (FDA) has approved updates to the full U.S. Prescribing Information (PI) for TRADJENTA ® (linagliptin) tablets and JENTADUETO ® (linagliptin and metformin. For patients with renal impairment, no dose adjustment for linagliptin is required. Linagliptin should not be used in patients with type 1 diabetes or for the.

Author: Daitilar Mezilar
Country: Chad
Language: English (Spanish)
Genre: Health and Food
Published (Last): 25 December 2015
Pages: 17
PDF File Size: 4.68 Mb
ePub File Size: 19.94 Mb
ISBN: 732-8-53865-610-6
Downloads: 32139
Price: Free* [*Free Regsitration Required]
Uploader: Mazshura

Rescue therapy was required by 5. Early safety data for linagliptin were provided by several dose-ranging studies.

Efficacy and Safety of Linagliptin (Tradjenta) in Adults With Type-2 Diabetes Mellitus

Economic costs of diabetes in the U. Dosing schedules tradjenta pi the three available DPP-4 tradjenta pi are presented in Table 2. For full prescribing information visit: The labeling for linagliptin also includes data from a week, randomized, double-blind, placebo-controlled study of linagliptin in traadjenta with a sulfonylurea and metformin in patients with type-2 diabetes.

tradjenta pi Since it was founded inthe family-owned company has tradjenta pi committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine. Boehringer Ingelheim Tradjenta pi, Inc. In another placebo-controlled study of tradjenta pi monotherapy 1, 5, or 10 mgno episodes of hypoglycemia were reported in patients with type-2 diabetes.

In a study of men with type-2 diabetes who received oral linagliptin 1 mg, 2. Other AEs reported in clinical studies of linagliptin included hypersensitivity and myalgia. The clinical safety of linagliptin has been assessed more than 4, patients who had type-2 diabetes.


The efficacy of linagliptin may be reduced when the drug is coadministered with a strong CYP3A4 or P-glycoprotein inducer e. In another study, Forst et al.

February 1, Estimated Study Completion Date: The DPP-4 inhibitor linagliptin does not prolong the QT interval at therapeutic and supratherapeutic doses.

If your A1C is still too high, maybe it’s a sign

Effect of linagliptin monotherapy tradjenha glycaemic control and markers tradjenta pi beta-cell function in patients tradjenta pi inadequately controlled type-2 diabetes: To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Hypoglycemia rarely develops in patients with type-2 diabetes during treatment with linagliptin, and the drug has a neutral effect on weight. Neither the 5-mg dose nor the mg dose of linagliptin increased the QT tradjenta pi, corrected for heart ip.

November tradjenta pi, Last Update Posted: Please review our tradjenta pi policy. You are encouraged to report negative side effects of prescription drugs to the FDA. In addition, diabetes is a major risk factor for heart disease and stroke and is the seventh leading cause of death in the U. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together tradjenta pi focus on patient needs.

The primary endpoint was the change from baseline in HbA 1c at week 12 in patients receiving combination therapy compared with those receiving metformin.


FDA Internet Application Site (Accessdata) Error

All Accepts Healthy Volunteers: Fasting plasma glucose was tradjenta pi reduced with linagliptin compared with placebo by 0. If metformin is contraindicated or is therapeutically tradjenta pi, the most commonly used second-line oral agents include sulfonylureas, such li glimepiride Amaryl, sanofi-aventis ; meglitinides glinidessuch as repaglinide Prandin, Novo Nor-disk ; and alpha-glucosidase inhibitors, such as acarbose Precose, Bayer.

In a randomized, placebo-controlled, double-blind, four-period crossover study, Ring et al. Similarly, tradjenta pi a study of linagliptin 1—10 mg in healthy Japanese men, no AEs were considered to be drug-related, and there were no episodes of hypoglycemia.

Evaluation of the pharmacokinetic interaction after multiple oral tradjenta pi of linagliptin and digoxin in healthy volunteers.

Boehringer Ingelheim Boehringer Ingelheim. The reductions in HbA 1c achieved with linagliptin, tradjenta pi, tradjjenta less than those achieved with metformin, a sulfonylurea, or pioglitazone. QT Interval Prolongation No significant changes in electrocardiographic parameters were observed in clinical studies of linagliptin.

TGA eBS – Product and Consumer Medicine Information

trafjenta Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal tradjenta pi. In a subgroup of patients with a baseline glycosylated hemoglobin HbA 1c of 9. National diabetes tradjenta pi sheet: