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Boehringer Ingelheim And Lilly Initiate MARLINA Clinical Trial To Evaluate Use Of Tradjenta® (linagliptin) Tablets In Patients With Type 2 Diabetes And Albuminuria

RIDGEFIELD, Conn. and INDIANAPOLIS, March 19, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the initiation of a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with type 2 diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio (UACR) 30-3000 mg/g creatinine), while remaining on current standard therapy for diabetic nephropathy. The name of the clinical trial is MARLINA (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin), and it can be found on ClinicalTrials.gov under identifier number, NCT01792518.

In diabetes, high levels of blood glucose can damage the kidneys' filters. Over time, damage to the kidneys' filters can leave people with type 2 diabetes at risk for developing renal impairment. One of the first signs of damaged kidneys and early-stage renal disease is having the protein albumin leak out of the kidneys into the urine. 1 

"What is of particular interest is that this study will evaluate the glycemic efficacy and safety of linagliptin therapy in patients with type 2 diabetes whose kidneys are excreting significant amounts of albumin, a marker of both kidney damage as well as an overall increased cardiovascular risk," 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 trial.

The primary endpoint of MARLINA is the change from baseline in HbA1c after 24 weeks of treatment. The study is expected to be completed in 2014.

"The initiation of this new trial marks an important study as it may provide us with further insight into treating patients with type 2 diabetes who also have renal disease," said Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim. "MARLINA demonstrates our ongoing commitment to diabetes research and the development of products aimed at meeting the specific needs of the diabetes community."

Linagliptin, marketed in the U.S. as TRADJENTA ® , is a once-daily tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). With linagliptin, no dose adjustment is required regardless of declining renal function.

To learn more about TRADJENTA and for full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

About MARLINA Study DesignMARLINA is a 24-week, Phase IIIb, multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the glycemic efficacy of once-daily administration of linagliptin 5 mg in patients with type 2 diabetes with micro- or macroalbuminuria (30-3000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker.

What are TRADJENTA (linagliptin) tablets?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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