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FDA Approves New Diabetes Drug

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On May 2, the US Food and Drug Administration (FDA) approved the diabetes medicine linagliptin (brand name Tradjenta), developed by Boehringer Ingelheim Pharmaceuticals, Inc., and Eli Lilly and Company. Tradjenta is a new member of the class of drugs known as DPP-4 inhibitors. (Saxagliptin [Januvia] and sitagliptin [Onglyza] are the other members of this drug class.)

DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions.

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In clinical trials, Tradjenta has been associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) of up to 0.7% compared to placebo (inactive treatment), and has also been shown to reduce fasting glucose and after-meal glucose levels.

The tablets will be offered in a 5-milligram dose to be taken once daily, with or without food. Tradjenta is approved for use alone or in combination with metformin (Glucophage and others), sulfonylureas (DiaBeta, Glynase, Micronase, Glucotrol, Glucotrol XL, Amaryl), or pioglitazone (Actos) in adults with Type 2 diabetes. No dose adjustment is recommended for people with kidney or liver impairment.

This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). The most common side effects in people using Tradjenta are stuffy or runny nose and sore throat.

For more information, see the press release on the Eli Lilly Web site or see Tradjenta’s Web site.

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