Data from phase III trials supports safety, efficacy of linagliptin in treating T2D in African-American adults
Published on May 16, 2014 at 8:08 AM
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 (NYSE: LLY) announced. Additionally, 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.
"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, M.D., Ph.D., 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.