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Eli Lilly And Co And Boehringer Ingelheim Pharmaceuticals, Inc. Announces Retrospective Analysis Of Linagliptin Data In Sub-Populations With Type 2 Diabetes


Monday, 6 May 2013 06:39pm EDT 

Eli Lilly And Co and Boehringer Ingelheim Pharmaceuticals, Inc. announced results from two new pooled analyses of phase III data with dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin. Data were included from Hispanic/Latino adults with type 2 diabetes (T2D), a population that is disproportionately affected by T2D. Data pooled from six phase III studies showed that treatment with linagliptin reduced glucose levels (HbA1c) versus placebo in this patient population. In a second retrospective analysis, data were pooled from two phase III studies that included people with long-standing T2D (>/=10 years). Analysis showed reductions in HbA1c from baseline with linagliptin versus placebo. Sub-population of Hispanic/Latino Adults with T2D The findings from first presentation were derived from six randomized, double-blind, placebo-controlled phase III studies of linagliptin 5 mg/d given as monotherapy or in addition to common glucose-lowering therapies. Of six studies included in analysis, two were 18 weeks in duration and four were 24 weeks in duration. Total of 731 American Hispanic/Latino patients (467 who received linagliptin and 264 who received placebo) were included in the full analysis set (FAS), which was comprised of all randomized patients treated with at least one dose of the study drug, and who had their HbA1c measured at baseline and at least once during treatment period. Primary efficacy endpoint was change in HbA1c from baseline to 18 or 24 weeks. 

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