Results from the MARLINA-T2DTM trial demonstrated that Trajenta® (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 will be presented tomorrow at the American Diabetes Association 76th Scientific Sessions® in New Orleans.
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“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 Trajenta®, 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 the 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-T2DTM examined the safety and efficacy of Trajenta® 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, Trajenta® 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 Trajenta® versus placebo. Trajenta® was well tolerated in the trial, with a kidney (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-T2DTM trial results further support the use of Trajenta® as a once-daily therapy that does not require dose adjustment regardless of renal function.”
Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. as Tradjenta® (linagliptin), as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with T2D. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
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