Boehringer Ingelheim, one of the world’s 20 leading pharmaceutical companies, and Eli Lilly and Company have started a phase IIIb trial “MARLINA” to evaluate the glycaemic efficacy and safety of linagliptin in type 2 diabetes patients with prevalent albuminuria, and urinary albumin-to-creatinine (UACR) ratio 30-3000 mg/g creatinine, in addition to current standard therapy for diabetic nephropathy.

"With linagliptin, no dose adjustment is required even for patients with declining renal 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 trial. "What is of particular interest is that this study will evaluate the glycaemic 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."

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

"The initiation of this new trial reinforces our ongoing commitment to the field of type 2 diabetes" said Professor Klaus Dugi, corporate senior vice president Medicine, Boehringer Ingelheim. "It is important to find more treatment options, especially for those patients who are at risk of renal and cardiovascular disease and who have limited choices of treatment.”

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory authorities worldwide approved linagliptin for the treatment of adult patients with type 2 diabetes as monotherapy or in combination with metformin, metformin plus sulphonylurea, and as add-on therapy to insulin. In the US, linagliptin is also approved for use in this population with sulphonylurea and with pioglitazone. With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta (linagliptin) and in the US as Tradjenta (linagliptin) tablets, as a once-daily tablet that is used along with diet and exercise to improve glycaemic control in adults with type 2 diabetes. 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). With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.

Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies’ strengths as two of the world’s leading pharmaceutical companies, combining Boehringer Ingelheim’s solid track record of research-driven innovation and Lilly’s innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.