New medicine approved by FDA to treat type 2 diabetes

(ARA) - Diabetes (both type 1 and type 2) affects approximately 25.8 million Americans and an estimated 220 million people worldwide. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of diabetes cases. Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

Now there is good news for people with type 2 diabetes. Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) recently approved TRADJENTA(TM) (linagliptin) tablets, a new prescription medication used along with diet and exercise, to lower blood sugar in adults with type 2 diabetes.

TRADJENTA (pronounced TRAD gen ta) can be used alone or with other commonly used medications for type 2 diabetes - metformin, sulfonylurea or pioglitazone. TRADJENTA lowered hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo) in clinical trials.

A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months.

TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

"Many people with type 2 diabetes are not able to control their blood sugar with diet and exercise alone and may also require one or more medications," says Dr. John Gerich, professor of medicine, at the University of Rochester School of Medicine. "The FDA approval of TRADJENTA is exciting because there is only one dose to remember for patients, regardless of kidney or liver impairment. With TRADJENTA, physicians will have another option for managing type 2 diabetes, a potentially devastating condition."

TRADJENTA is a tablet that can be taken once a day, with or without food. It lowers blood sugar by increasing incretin levels, which increase insulin levels after meals and throughout the day.

It was approved based on a clinical trial program which included approximately 4,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating TRADJENTA alone and with other commonly-used medications for type 2 diabetes.

TRADJENTA lowered fasting plasma glucose (FPG) compared to placebo, when used as monotherapy and in combination with metformin, sulfonylurea or pioglitazone. FPG is used to determine glucose levels in a fasting state, usually upon waking up in the morning.

It also lowered two-hour post-prandial glucose (PPG) levels compared with placebo as monotherapy and when used in combination with metformin. PPG is used to determine glucose levels after meals, usually two hours after eating.

To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com or call Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling (800) 542-6257.

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(TM) (linagliptin) tablets 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(R), Rimactane(R), Rifater(R), Rifamate(R)), 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 FDA.  Visit http://www.fda.gov/medwatch or call (800) FDA-1088.