Linagliptin Approved in Canada for Type 2 Diabetes

Megan Brooks

October 04, 2011

October 4, 2011 — Canadian regulators yesterday approved linagliptin (Trajenta, Boehringer Ingelheim Canada and Eli Lilly Canada) for improving blood glucose control in adults with type 2 diabetes, either as a stand-alone or in combination with other type 2 diabetes medications.

Health Canada's approval of linagliptin comes on the heels of US Food and Drug Administration approval of the drug in May 2011. The drug was approved in Europe in August 2011.

Taken orally, linagliptin boosts the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 (DPP-4).

No Need for Dose Adjustments

Unlike other DPP-4 inhibitors, linagliptin has only 5% renal excretion, meaning no dose adjustment is needed in adults with mild or moderate renal impairment, David Lau, MD, PhD, chair of the Diabetes and Endocrine Research Group and professor of medicine, biochemistry and molecular biology, University of Calgary, Alberta, Canada, notes in a statement.

"This is convenient for both patients and physicians because one dose is the right dose for all adult patients," he adds. The approved dose is 5 mg once daily.

Linagliptin has been studied as monotherapy (vs placebo) and in combination with other diabetes medications, such as metformin and/or a sulfonylurea, in more than 6000 adults with type 2 diabetes. In clinical trials, linagliptin reduced hemoglobin A1c levels up to 0.7% compared with placebo, the company notes.

Linagliptin alone or with metformin and/or a sulfonylurea also led to significant reductions in fasting plasma glucose and 2-hour postprandial glucose levels compared with placebo, the company says.

Linagliptin was shown to have a favorable safety and tolerability profile. In a pooled analysis of placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to that seen with linagliptin (54% vs 55%).

The most commonly reported adverse reaction was hypoglycemia observed with the triple combination of linagliptin plus metformin plus a sulfonylurea (15% with linagliptin vs 8% with placebo). None of these events were classified as severe. Weight did not change significantly from baseline in clinical trials, the company notes.

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