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MARLINA-T2D trial results show Tradjenta reduces blood sugar in adults with T2D at risk for kidney impairment
Ridgefield, Connecticut | Monday, June 13, 2016, 17:00 Hrs  [IST]

Results from the MARLINA-T2D trial demonstrated that Tradjenta (linagliptin), which is marketed by Boehringer Ingelheim and Eli Lilly and Company, reduced blood sugar in adults with type 2 diabetes (T2D) who are at risk for kidney impairment, with a renal safety profile similar to that seen in other trials. The findings were presented at the American Diabetes Association 76th Scientific Sessions in New Orleans.

"Up to half of people with type 2 diabetes experience long-term problems with kidney function," said Professor Per-Henrik Groop, professor of nephrology, and chief physician at the division of nephrology, Helsinki University Central Hospital, Helsinki, Finland and principal investigator of the MARLINA-T2D trial. "Diabetes treatment options are generally limited for this group. These results support the use of Tradjenta, with just one dose for all patients, including those with type 2 diabetes who have early signs of kidney disease."

In people who have diabetes, high levels of blood glucose can damage the kidneys' filters. Over time, the damage can increase risk for developing kidney impairment. One of the first signs of damaged kidneys and early stage kidney disease is leakage of the protein albumin out of the kidneys into the urine — a condition known as albuminuria that indicates risk for further worsening of kidney function.

MARLINA-T2D examined the safety and efficacy of Tradjenta versus placebo in 360 patients with T2D and albuminuria (defined as urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g creatinine). At 24 weeks, Tradjenta was associated with a significant 0.6 percent reduction in A1C (a measure of average blood glucose over the past two to three months) versus placebo. Change in albuminuria, as measured by UACR, was non-significant with Tradjenta versus placebo. Tradjenta was well tolerated in the trial, with a renal safety profile consistent with that of previous clinical trials.

"The treatment of type 2 diabetes is rarely a simple matter—people with this condition are often dealing with a multitude of complications, including problems with their kidneys," said Professor Hans-Juergen Woerle, global vice president medicine, Boehringer Ingelheim. "The MARLINA-T2D trial results further support the use of Tradjenta as a once-daily therapy that does not require dose adjustment regardless of renal function."

Tradjenta is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Tradjenta is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

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