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Positive Phase III Results for Diabetes Drug Linagliptin (Tradjenta) in Elderly Patients

Drug achieves significant reduction in blood glucose versus placebo (August 15)

According to data published in The Lancet, elderly people with type 2 diabetes (T2D) treated for 24 weeks with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta, Boehringer Ingelheim/Eli Lilly) 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 that of placebo.

Tradjenta (linagliptin) is approved for use as a once-daily 5-mg tablet along with diet and exercise to improve glycemic control in adults with T2D.

The publication reports on a 24-week, double-blind, phase III study in 241 elderly people (mean age, 74.9 years) with T2D who were randomly assigned to receive linagliptin 5 mg (n = 162) or placebo (n = 79) in addition to glucose-lowering drugs (i.e., metformin and/or sulfonylurea and/or basal insulin). The study’s primary endpoint was the 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).

Source: Eli Lilly; August 15, 2013.

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