FDA approves new treatment for Type 2 diabetes
The
U.S. Food and Drug Administration on May 2, 2011 approved Tradjenta
(linagliptin) tablets, used with diet and exercise, to improve blood
glucose control in adults with Type 2 diabetes.
People with Type 2
diabetes do not produce or respond normally to insulin, a hormone that
regulates the amount of glucose in the blood. Over time, high blood
glucose levels can increase the risk for serious complications,
including heart disease, blindness, and nerve and kidney damage.
"This
approval provides another treatment option for the millions of
Americans with Type 2 diabetes," said Mary Parks, M.D., director of the
Division of Metabolism and Endocrinology Products in the FDA’s Center
for Drug Evaluation and Research. “It is effective when used alone or
when added to existing treatment regimens.”
Type 2 diabetes is the
most common form of the disease, affecting between 90 percent and 95
percent of the 24 million people in the United States with diabetes.
Tradjenta increases the level of hormones that stimulate the release of
insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 or
DPP-4, which leads to better blood glucose control.
Tradjenta was
demonstrated to be safe and effective in eight double-blind,
placebo-controlled clinical studies involving about 3,800 patients with
Type 2 diabetes. The studies showed improvement in blood glucose control
compared with placebo.
Tradjenta has been studied as a
stand-alone therapy and in combination with other Type 2 diabetes
therapies including metformin, glimepiride, and pioglitazone. Tradjenta
has not been studied in combination with insulin, and should not be used
to treat people with Type 1 diabetes or in those who have increased
ketones in their blood or urine (diabetic ketoacidosis).
Tradjenta
will be dispensed with an FDA-approved Patient Package Insert that
explains the drug’s uses and risks. The most common side effects of
Tradjenta are upper respiratory infection, stuffy or runny nose, sore
throat, muscle pain, and headache.
Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Conn., and Indianapolis-based Eli Lilly Co.
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