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RIDGEFIELD, Conn. and
May 15, 2014 /PRNewswire/ -- 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
"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.
2About the Retrospective Pooled Analysis The retrospective pooled analysis from eight randomized, placebo-controlled phase III trials included 336 adults with T2D from North and
South America who self-reported their race as African-American. Of the participants, 173 received linagliptin 5 mg and 163 received placebo once-daily, either as monotherapy or add-on to various glucose-lowering regimens, for 18 weeks (two trials) or 24 weeks (six trials). The primary efficacy endpoint was change in A1c from baseline to 18 weeks or 24 weeks. Mean baseline A1c levels were 8.53 percent in the linagliptin group and 8.61 percent in the placebo group. Safety was assessed according to incidence and intensity of adverse events (AEs), including the incidence and intensity of hypoglycemia.
Key findings from the retrospective pooled analysis:
Placebo-adjusted mean change (95 percent CI) in hemoglobin A1c levels (a measure of average blood glucose) from baseline of –0.69 percent (–0.92, –0.46) at week 18 (eight trials) and −0.64 percent (−0.90, −0.39) at week 24 (six trials).
Similar proportions of patients in the linagliptin and placebo groups experienced AEs (65.3 percent and 68.1 percent, respectively) with a lower percentage of patients experiencing drug-related AEs in the linagliptin group compared with placebo (9.2 percent and 13.5 percent, respectively).
Incidence of hypoglycemia was similar across groups (12.1 percent on linagliptin, 11.7 percent on placebo).
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily, 5-mg tablet used along with diet and exercise to improve glycemic control in adults with T2D. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. TRADJENTA has not been studied in patients with a history of pancreatitis.