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Phase III studies show linagliptin improved blood glucose control in Asian adults with type 2 diabetes
Date:6/22/2013

bA1c of 7.95 percent) at 24 weeks among Asian patients from China, Malaysia, and the Philippines, compared with a reduction of 0.18 percent (from a mean baseline HbA1c of 8.09 percent) in the placebo group (placebo-corrected difference of -0.50 percent; 95 percent confidence interval [CI]: -0.71, -0.28; p<0.0001). In a pre-defined subgroup of patients with a baseline HbA1c of at least 8.5 percent, treatment with linagliptin resulted in a placebo-adjusted reduction in HbA1c of 0.91 percent (p<0.0001) at 24 weeks.3 HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.3

Results from the second study showed an HbA1c reduction of 0.66 percent (from a mean baseline HbA1c of 7.99 percent) at 24 weeks among Asian patients from China, Malaysia, and the Philippines who received linagliptin added to metformin at 24 weeks, versus a reduction of 0.14 percent (from a mean baseline HbA1c of 8.00 percent) among patients receiving placebo added to metformin (placebo-corrected difference in HbA1c was -0.52 percent; 95 percent CI: -0.70, -0.34; p<0.0001).[4]

In both studies, the incidence of adverse events (AEs) was similar in each treatment group compared with placebo. The incidence of AEs for linagliptin were 28.0 percent in the monotherapy study and 27.3 percent in the add-on therapy study, and comparable to the placebo arm (28.3 percent and 28.0 percent, respectively). In the monotherapy study, drug-related AEs were reported in 3.0 percent of linagliptin patients and 2.0 percent of placebo patients; in the add-on trial, drug-related AEs were reported in 2.4 percent of linagliptin pati
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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