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

ents and 0.0 percent of placebo patients. In addition, investigator-defined hypoglycemia occurred in 0.5 percent of linagliptin patients and 0.0 percent of placebo patients in the monotherapy study, and in 1.0 percent of patients in both groups of the add-on study.3, 4

About the Studies
The first study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of linagliptin monotherapy for 24 weeks in Asian patients with inadequately controlled type 2 diabetes mellitus. The study included a total of 300 patients with T2D from China (n=261), Malaysia (n=22) and the Philippines (n=17). Patients who were treatment naïve or who had been treated with one antihyperglycemic drug were randomized to either linagliptin 5 mg daily or placebo following a 4-week washout period of prior drugs. The primary endpoint was change from baseline in mean HbA1c after 24 weeks.3 Mean HbA1c levels at baseline were 7.95 percent for patients in the linagliptin group and 8.09 percent for patients in the placebo group.

The second study, also a randomized, double-blind, placebo-controlled trial, evaluated the efficacy and safety of linagliptin as add-on therapy to metformin in Asian patients with inadequately controlled type 2 diabetes mellitus. The study included a total of 306 patients with T2D from China (n=265), Malaysia (n=17) and the Philippines (n=24). Antihyperglycemic drugs other than metformin were washed out for 4 weeks prior to randomization to either linagliptin 5mg daily or placebo added to metformin. The primary endpoint of the study was change from baseline in mean HbA1c after 24 weeks.4 Mean HbA1c levels at baseline were 7.99 percent for patients in the linagliptin group and 8.00 percent for pa
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SOURCE Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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