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FDA OKs BI/Lilly's Tradjenta as add-on to insulin

World News | August 20, 2012


Selina McKee

FDA OKs BI/Lilly's Tradjenta as add-on to insulin

US regulators have approved a label change for Boehringer Ingelheim/Eli Lilly's Tradjenta that includes its use as an add-on therapy to insulin in adult patients with Type II diabetes.

The DPP-4 inhibitor received its first green light in the US back in May 2011 to improve blood glucose control in adults with type 2 diabetes, in tandem with diet and exercise, and can now be used as monotherapy or in combination with other commonly prescribed diabetes drugs such as metformin, sulfonylurea, pioglitazone or insulin.

The drug increases the level of hormones that stimulate the release of insulin after a meal, by inhibiting the enzyme dipeptidyl peptidase-4 (DPP-4), which leads to better blood glucose control. 

Indeed, the US Food and Drug Administration's decision came on the back of data from a 52-week, randomised, double-blind, placebo-controlled Phase III  trial which showed that adding Tradjenta (linagliptin) to insulin "produced better glucose control than insulin alone, with a similar incidence of (hypoglycemia) low blood sugar in both treatment groups", the firms said.

In addition, the drug is the first member of its class to be cleared for use at one dosage strength - 5 mg once-daily - and the groups claims there is no need for dose adjustment regardless of kidney function or liver impairment.

"Many people with type II diabetes taking insulin also require additional medication...[and]...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," commented John Smith, senior vice president for clinical development and medical affairs at Boehringer Ingelheim Pharmaceuticals.

The new additions to the label also includes data from a clinical study in people with severe chronic renal impairment, which showed that the use of the drug plus other glucose-lowering therapies provided a statistically-significant improvement in glycated haemoglobin compared to placebo, which is particularly pertinent as around 40% of Type II diabetics have some degree of renal impairment.

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