Health Canada approves Trajenta (linagliptin) for type 2 diabetes

Boehringer Ingelheim Canada and Eli Lilly Canada today announced that Health Canada has approved Trajenta™ (linagliptin), a new oral therapy to improve glycemic control in Canadian adults with type 2 diabetes. Trajenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first of its class to be approved at one dosage strength with no dose adjustment required in patients with mild or moderate renal impairment.

Trajenta can be used as a monotherapy in conjunction with diet and exercise in patients for whom metformin is inappropriate due to contraindications or intolerance, or in combination with other commonly prescribed medications for type 2 diabetes in conjunction with diet and exercise - providing Trajenta with the broadest indication of the DPP-4i class of medications in the Canadian market. Studies show that Trajenta is efficacious with a favourable safety and tolerability profile, reducing hemoglobin A1c levels up to 0.7 per cent compared to placebo. A1c is used as a marker in people with diabetes to determine the efficacy of glucose-lowering therapies.

"Trajenta is an important new option for patients with Type 2 diabetes.  Unlike other DPP-4 inhibitors, Trajenta has only five per cent renal excretion, meaning no dose adjustment is needed in adult patients with mild or moderate renal impairment," says David Lau, M.D., Ph.D., FRCPC, endocrinologist, Chair, Diabetes and Endocrine Research Group, Professor of Medicine, Biochemistry & Molecular Biology, University of Calgary. "This is convenient for both patients and physicians, because one dose is the right dose for all adult patients."

As type 2 diabetes progresses, there is an increasing risk of declining renal function. About 67 per cent of type 2 diabetes patients are at high risk of declining renal function and approximately 30 per cent already have declining renal function. Diabetes patients with declining renal function have an increased risk of serious complications including hypoglycaemic episodes.

Some of the currently available anti-diabetic medications are predominantly cleared through the kidneys before leaving the body.  One of the challenges is that as kidney function declines, patients on these medications often have to adjust the dose of their medication, or stop taking it altogether. Metformin and sulfonylrueas, which are two of the most commonly prescribed oral medications in Canada, as well as the DDP-4 inhibitors currently available, are either not indicated for use in patients with compromised renal function, or must be adjusted and monitored carefully as a patient's renal function declines.

"The approval of Trajenta marks the first regulatory milestone for the Boehringer Ingelheim and Eli Lilly and Company alliance in Canada," said Dr. Ted Witek, President and CEO, Boehringer Ingelheim Canada. "Together our companies are dedicated to providing type 2 diabetes patients with a new treatment option to improve glycemic control without the concerns of dose adjustments for patients with mild to moderate renal impairment."

"We are extremely proud to offer a new treatment option that could potentially help the millions of people with Type 2 diabetes in Canada," said Michael Mason, President and General Manager, Eli Lilly Canada.  "Trajenta is the first of what we hope will be many new treatment options this alliance brings to improve patient care in diabetes."

Source:

BOEHRINGER INGELHEIM

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