Tradjenta (linagliptin), the new type 2 diabetes drug from Boehringer Ingelheim and Eli Lilly, has been approved for use as add-on therapy to insulin by the US Food and Drug Administration (FDA).
The prescription medication lowers blood sugar in adults with type 2 diabetes, and can be used as monotherapy or in combination with other commonly prescribed medicines to treat type 2 diabetes, such as metformin, sulfonylureas or insulin.
Its labelling has now been updated in the US to include the drug’s use as an add-on to insulin therapy in treatment of diabetes.
The FDA’s approval was based on data from a 52-week, phase III trial, which showed that use of Tradjenta in combination with insulin improved glycemic control better than insulin alone, with similar incidence of hypoglycemia (low blood sugar) noted in both treatment groups.
John Smith, senior vice president for clinical development and medical affairs at Boehringer Ingelheim Pharmaceuticals, said the health regulator’s decision means Tradjenta can be “an effective add-on therapy with a demonstrated safety profile to help adult patients on insulin to improve their blood sugar control”.
He added that the drug is the first member of its class (DPP-4 inhibitors) to be approved at one dosage strength (5 mg, once-daily), meaning no dose adjustment is required regardless of declining renal function or hepatic impairment.

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