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FDA approves linagliptin for type 2 diabetes
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The FDA recently approved linagliptin tablets, used in conjunction with diet and exercise, to improve blood glucose control in adults with type 2 diabetes.
Linagliptin (Tradjenta, Boehringer Ingelheim Pharmaceuticals) increases the level of hormones that stimulate the release in insulin after a meal by blocking the enzyme dipeptidyl peptidase-4.
The drug 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.
“This approval provides another treatment option for the millions of Americans with type 2 diabetes,” Mary Parks, MD, director of the division of metabolic and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “It is effective when used alone or when added to existing treatment regimens.”
Linagliptin has been studied as a standalone therapy and in combination with other type 2 diabetes therapies including metformin, glimepiride and pioglitazone (Actos, Takeda). It 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 diabetic ketoacidosis.
An FDA-approved patient package insert will be dispensed with linagliptin to explain the drug’s uses and risks. The most common adverse effects associated with linagliptin are upper respiratory infection, stuffy or runny nose, sore throat, muscle pain and headache.
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