In the U.S., linagliptin 5 mg is marketed under the trade name Tradjenta™ (linagliptin) tablets and was approved by the
"The Phase III clinical trial program has demonstrated efficacy with linagliptin in the treatment of adults with type 2 diabetes," said Prof.
Studies show linagliptin has a demonstrated efficacy and safety profile, reducing hemoglobin A1C (HbA1C or A1C) levels by a mean of -0.6 to -0.7 percent(2,3) (compared to placebo). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months and is used as a marker to determine the efficacy of glucose-lowering therapies.
"Linagliptin is primarily excreted unmetabolized via bile and gut, meaning no dose adjustment is needed in adult patients with kidney or liver impairment," said Prof.
The approval of linagliptin in
In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to that seen with linagliptin (53.8 percent versus 55.0 percent).
The most frequently reported adverse reaction was hypoglycemia observed with the triple combination of linagliptin plus metformin plus sulfonylurea.
"The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes," said
What is TRADJENTA?
TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
It is not known if TRADJENTA is safe and effective when used with insulin.
Important Safety Information
Who should not take TRADJENTA?
Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.
Symptoms of a serious allergic reaction to TRADJENTA are rash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.
What should I tell my doctor before taking TRADJENTA?
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin. If you take TRADJENTA with another medicine that can cause low blood sugar (hypoglycemia), such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, or feeling jittery.
Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.
TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.
Tell your doctor if you are pregnant or planning to become pregnant or are breastfeeding or plan to breastfeed.
What are the possible side effects of TRADJENTA?
The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.
You are encouraged to report negative side effects of prescription drugs to the
For more safety information, please see Patient Information and full Prescribing Information.
To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com or call
Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.
Approximately 25.8 million Americans(7) and an estimated 220 million people worldwide(8) have type 1 and type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.(7) Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.(9)
Boehringer Ingelheim and
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim,
As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2010, Boehringer Ingelheim posted net sales of approximately
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in
About Lilly Diabetes
For more than 85 years, Lilly has been a worldwide leader in pioneering industry-leading solutions to support people living with and treating diabetes. Lilly introduced the world's first commercial insulin in 1923, and remains at the forefront of medical and delivery device innovation to manage diabetes. Lilly is also committed to providing solutions beyond therapy — practical tools, education, and support programs to help overcome barriers to success along the diabetes journey. At Lilly, the journeys of each person living with or treating diabetes inspire ours. For more information, visit www.lillydiabetes.com.
This press release contains forward-looking statements about linagliptin tablets for the treatment of type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that linagliptin will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the
(1)Trajenta™ (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
(2)Taskinen MR, Rosenstock J, Tamminen I, et al: Safety and efficacy of linagliptin as add-on therapy to metformin in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Diabetes Obes Metab 2011;13:65-74.
(3)Del Prato S, Barnett AH, Huisman H, et al: Effect of linagliptin monotherapy on glycaemic control and markers of B-cell function in patients with inadequately controlled type 2 diabetes: a randomised controlled trial. Diabetes Obes Metab 2011;13:193-287.
(4)Barnett AH, Harper R, Toorawa R, et al: Linagliptin monotherapy improves glycaemic control in type 2 diabetes patients for whom metformin therapy is inappropriate, 46th Annual Meeting of the
(5)Owens DR, Swallow R, Woerle HJ, et al: Linagliptin improves glycemic control in type 2 diabetes patients inadequately controlled by metformin and sulfonylurea without weight gain and low risk of hypoglycemia, 70th American Diabetes Association Scientific Sessions.
(6)Lewin AJ, Arvay L, Liu D, et al: Safety and efficacy of linagliptin as add-on therapy to a sulphonylurea in inadequately controlled type 2 diabetes, 46th Annual Meeting of the
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