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Retrospective Analysis Of Linagliptin Data In Sub-populations With Type 2 Diabetes Presented At AACE 22nd Annual Scientific & Clinical Congress

RIDGEFIELD, Conn. and INDIANAPOLIS, May 6, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from two new pooled analyses of phase III data with the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin, presented at the American Association of Clinical Endocrinologists (AACE) 22 nd Annual Scientific & Clinical Congress.

In one retrospective pooled analysis, data were included from Hispanic/Latino adults with type 2 diabetes (T2D), a population that is disproportionately affected by T2D. 1 Data pooled from six phase III studies showed that treatment with linagliptin reduced glucose levels (HbA 1c) 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).  The analysis showed reductions in HbA 1c from baseline with linagliptin versus placebo. 

"Response to treatment can vary between sub-populations of adults with type 2 diabetes," said Christophe Arbet-Engels, MD, PhD, vice president, clinical development and medical affairs metabolic, Boehringer Ingelheim Pharmaceuticals, Inc. "Those with long-standing type 2 diabetes or of Hispanic/Latino origin are often difficult to treat or under-treated."

About Poster No. 1118 - Sub-population of Hispanic/Latino Adults with T2DThe findings from the 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. 1 Of the six studies included in the analysis, two were 18 weeks in duration and four were 24 weeks in duration. 1 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 HbA 1c measured at baseline and at least once during the treatment period. 1 The primary efficacy endpoint was change in HbA 1c from baseline to 18 or 24 weeks. 1  Baseline HbA 1c 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 included 1:
  • 0.58% reduction in HbA 1c 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 T2DFor 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 HbA 1c from baseline to 24 weeks. 2  Baseline HbA 1c 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 included 2:
  • 0.66% reduction in HbA 1c compared to placebo after 24 weeks of treatment (CI: -0.95, -0.38; p<0.0001)
  • 21.3% reported treatment-related AEs vs. 16.3% in the placebo arm

Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily 5mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes.  Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).  Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.

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