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Retrospective analysis of linagliptin data in sub-populations with type 2 diabetes presented at AACE 22nd Annual Scientific & Clinical Congress
Date:5/6/2013

sup> A 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 the treatment period.1 The primary efficacy endpoint was change in HbA1c from baseline to 18 or 24 weeks.1  Baseline HbA1c levels were 8.25% in the linagliptin group and 8.23% in the placebo group.1

Key findings of the retrospective analysis for the linagliptin treatment group included1:

  • 0.58% reduction in HbA1c compared to placebo after 24 weeks of treatment (95% confidence interval [CI]-0.74, -0.42; p<0.0001)
  • 14.6% reported drug-related AEs vs. 18.4% for placebo

About Poster No. 1119 - Sub-population of Adults with Long-standing T2D
For the second retrospective analysis, researchers pooled data from two phase III studies of 202 patients with a reported T2D duration of ≥10 years, who received either linagliptin 5 mg/d (n=122) or placebo (n=80).2  The average exposure to both treatments was 169 days.2  A total of 192 patients (117 linagliptin and 75 placebo) were included in the FAS.2  The primary endpoint was change in HbA1c from baseline to 24 weeks.2  Baseline HbA1c levels were 8.07% in the linagliptin group and 8.45% in the placebo group.2

Key findings of the retrospective analysis for the linagliptin treatment group included2:

  • 0.66% reduction in HbA1c compared to placebo after 24 weeks of treatment (CI: -0.95, -0.38; p<0.0001)
  • 21.3% reported treatment-related AEs
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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