Boehringer Ingelheim and Lilly initiate MARLINA™ clinical trial to evaluate use of Trajenta® (linagliptin) in patients with type 2 diabetes and albuminuria

“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.1 With linagliptin, no dose adjustment is required regardless of declining renal function or hepatic impairment.^1,2

About MARLINA™ Study Design

MARLINA™ is a Phase IIIb, multicentre, multinational, randomised, double-blind, placebo controlled, parallel group study to evaluate the glycaemic efficacy of once daily administration of linagliptin (5 mg for 24 weeks) in type 2 diabetes patients, with micro- or macroalbuminuria (30-3000mg/g creatinine) in addition to current standard treatment for diabetic nephropathy (ACEi or ARB).

About Linagliptin

Linagliptin (5 mg, once daily) is marketed in Europe as Trajenta® (linagliptin) and in the U.S. 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.^1,2

About Diabetes

An estimated 371 million people worldwide have type 1 and type 2 diabetes.³ Type 2 diabetes is the most common type, accounting for an estimated 90% of all diabetes cases.⁴ Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.⁵

Boehringer Ingelheim and Eli Lilly and Company

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. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

References

1. Jentadueto® (linagliptin/metformin HCI) tablets. Highlights of Prescribing Information. Initial US Approval: 2012.
2. EMA. Trajenta® (linagliptin) tablets. EMA Summary of Product Characteristics. 2011.
3. International Diabetes Federation. IDF Diabetes Atlas Poster (2012 Update – 5th Edition). 2012.
4. World Health Organization. Fact Sheet No. 312 What is Diabetes? 2009 [cited 2013 January 2013]; Available from: http://www.who.int/mediacentre/factsheets/fs312/en/index.html#
5. International Diabetes Federation. What is Diabetes? IDF Diabetes Atlas. 2011; (5th Edition).

*MARLINA™ (efficacy, safety & Modification of Albuminuria in type 2 diabetes subjects with Renal disease with LINAgliptin).