RIDGEFIELD, Conn. and INDIANAPOLIS, Aug. 15, 2013 /PRNewswire/ -- Data published in The Lancet showed that elderly people with type 2 diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (TRADJENTA ®), marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (Lilly; NYSE: LLY), experienced significant reductions in blood glucose levels (HbA1c) compared with those receiving placebo. In addition, the overall safety and tolerability profile of linagliptin was similar to placebo. 1
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 (increased ketones in the blood or urine). TRADJENTA has not been studied in patients with a history of pancreatitis and it is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using TRADJENTA.
"Elderly individuals represent approximately 15 percent of people with type 2 diabetes worldwide, 2" said Professor Anthony H. Barnett, MD, FRCP, Heart of England NHS Foundation Trust and University of Birmingham, United Kingdom. "This study may help inform treatment decisions for improving glycemic control in the elderly."
The publication reports on a 24-week, double-blind, parallel-group, multinational, phase III study in 241 elderly people (=70 years; mean age, 74.9 years) with T2D randomized to receive linagliptin 5 mg (n=162) or placebo (n=79), in addition to existing glucose-lowering drugs (i.e. metformin and/or sulfonylurea and/or basal insulin). The primary endpoint was change in HbA1c from baseline (7.8 percent for linagliptin versus 7.7 percent for placebo) to week 24. Key results from the study showed that the mean change from baseline in HbA1c with linagliptin was -0.64 percent (p<0.0001) after 24 weeks, which showed superiority versus placebo, adjusted for a mean 0.04 percent HbA1C increase for placebo . In addition, analysis of a secondary endpoint showed that the placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin was -20.7 mg/dL (-1.15 mmol/L; p<0.0001).