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 (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,” Dr. John Gerich said, 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.
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