English Court Rules Against Lilly in Alimta Vitamin Dosage Regimen Patent Lawsuit

Data from a retrospective pooled analysis of eight phase III trials (two 18-week and six 24-week) of linagliptin 5 mg once-daily, showed reductions from baseline A1c at 18 (eight trials) and 24 (six trials) weeks compared to placebo in African-American adults with type 2 diabetes (T2D), Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company announced. In addition, similar proportions of patients in the linagliptin and placebo groups experienced adverse events, including the incidence of investigator-reported hypoglycemia. These data were presented at the American Association of Clinical Endocrinologists (AACE) 23rd Annual Scientific & Clinical Congress in Las Vegas.[1]

"African-Americans have an increased risk of developing type 2 diabetes and are less likely to achieve glycemic targets due to genetic and environmental factors, yet they are underrepresented in clinical trials," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The findings from this retrospective pooled data analysis help support the efficacy and safety profile of linagliptin as a treatment option for African-American adults with type 2 diabetes. We are proud to contribute to the clinical knowledge about oral glucose-lowering drugs specifically in the African-American population."

According to the Centers for Disease Control and Prevention (CDC), African-Americans, along with other minority groups, are at a higher risk for T2D than the rest of the population.[2]

References

1. Thrasher J et al. Efficacy and Safety of TRADJENTA in Black/African American Patients with Type 2 Diabetes (T2D): Pooled Analysis From 8 Randomized, Placebo-controlled Phase 3 Trials. Presented at the American Association of Clinical Endocrinologists (AACE) 23rd Annual Scientific & Clinical Congress, 15–19 May, Las Vegas, Nevada.

2. Centers for Disease Control and Prevention. Groups Especially Affected by Diabetes. http://www.cdc.gov/diabetes/consumer/groups.htm. Accessed on 1 May 2014.