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Boehringer Ingelheim Unveils Diabetes Pipeline
Date:6/6/2009

eline to week 12.(1) Out of the 333 randomized patients, 268 patients received double-blind treatment with linagliptin (1 mg, n=65; 5 mg, n=66; 10 mg, n=66) or placebo.(1) An open-label arm with 65 patients on glimepiride was added for descriptive control.(1)

Additional results from the study

The addition of linagliptin to metformin treatment for 12 weeks resulted in clinically relevant and statistically significant reductions in HbA1c and fasting blood sugar or fasting plasma glucose (FPG) levels (p-values of less than 0.05%):(1)

  • Statistically significant reductions in mean HbA1c levels with linagliptin 5 mg and 10 mg compared with metformin alone (both p<0.001) were observed from week four though week 12.(1)
  • In addition, all linagliptin doses showed significant reductions in FPG levels compared with metformin alone (placebo-corrected mean changes from baseline; -19.2 mg/dL for 1 mg, -34.7 mg/dL for 5 mg, and -29.0 mg/dL for 10 mg).(1)
  • In the open-label comparator arm, the placebo-corrected mean change from baseline in HbA1c was -0.90 percent.(1)
  • More than 85% of the patients receiving the 5mg and 10mg doses of linagliptin demonstrated greater that or equal to 80% DPP-4 inhibition at trough at week 12(1)
  • HbA1c reductions of at least 0.5 percent were achieved in 44 percent to 53 percent of patients on linagliptin, but only in 13 percent of the patients receiving metformin alone.(1)

About type 2 diabetes

There are approximately 23.6(5) million Americans and 246 million people worldwide(6) with diabetes. Type 2 diabetes is the most common type of diabetes accounting for more than 90% of all diabetes cases in the developed world.(7) Every ten seconds two people develop diabetes and one person dies from diabetes-related causes around the world.(6) Each
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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