FDA approves new type 2 diabetes drug
The FDA has approved a new drug treatment to help improve blood glucose levels in type 2 diabetics—Boehringer Ingelheim and Eli Lilly's linagliptin (Tradjenta).
The drug is used in combination with diet and exercise and has been proven to be safe and effective in type 2 diabetes patients in eight double-blind, placebo-controlled studies enrolling an estimated 3,800 patients, according to the FDA.
"This approval provides another treatment option for the millions of Americans with type 2 diabetes," said Mary Parks, MD, 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 affects between 90 to 95 percent of the 24 million patients diagnosed with diabetes in the U.S., and linagliptin works by increasing a patient’s hormone level to stimulate the release of insulin after a meal by blocking the dipeptidyl peptidase-4 (DPP-4) enzyme.
The FDA said that the drug has been evaluated as a stand-alone treatment and in combination with other type 2 diabetes therapy including metformin, glimepiride (Amaryl, Sanofi-Aventis) and pioglitazone (Actos, Takeda Pharmaceuticals). However, the agency linagliptin has not been evaluated in combination with insulin and thus should not be used to treat type 1 diabetic patients or those who have diabetic ketoacidosis.
The FDA said that while the most common side effects of the drug are upper respitory infection, linagliptin will be marketed alongside a FDA Patient Package Insert outlining the drug’s benefits, as well as its risks.
The drug is used in combination with diet and exercise and has been proven to be safe and effective in type 2 diabetes patients in eight double-blind, placebo-controlled studies enrolling an estimated 3,800 patients, according to the FDA.
"This approval provides another treatment option for the millions of Americans with type 2 diabetes," said Mary Parks, MD, 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 affects between 90 to 95 percent of the 24 million patients diagnosed with diabetes in the U.S., and linagliptin works by increasing a patient’s hormone level to stimulate the release of insulin after a meal by blocking the dipeptidyl peptidase-4 (DPP-4) enzyme.
The FDA said that the drug has been evaluated as a stand-alone treatment and in combination with other type 2 diabetes therapy including metformin, glimepiride (Amaryl, Sanofi-Aventis) and pioglitazone (Actos, Takeda Pharmaceuticals). However, the agency linagliptin has not been evaluated in combination with insulin and thus should not be used to treat type 1 diabetic patients or those who have diabetic ketoacidosis.
The FDA said that while the most common side effects of the drug are upper respitory infection, linagliptin will be marketed alongside a FDA Patient Package Insert outlining the drug’s benefits, as well as its risks.