Boehringer, Lilly launch phase 3 diabetes trials

Hannah Blake

pharmaphorum

Boehringer Ingelheim and Eli Lilly have launched phase 3 clinical trials to evaluate the glycemic efficacy and safety of linagliptin in patients with type 2 diabetes with prevalent albuminuria, while remaining on current standard therapy for diabetic nephropathy.

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.

The primary endpoint of the phase 3 clinical trials called MARLINA is the change from baseline in HbA1c after 24 weeks of treatment.

"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. MARLINA demonstrates our ongoing commitment to diabetes research and the development of products aimed at meeting the specific needs of the diabetes community."

Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim.

The phase 3 clinical study is expected to be completed in 2014.

Boehringer and Lilly began their diabetes alliance in January 2011, focusing on three pipeline compounds, including linagliptin. In the United States, linagliptin is marketed as Tradjenta.