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Boehringer Ingelheim Announces Pivotal Phase III Data Showing Linagliptin Reduced Blood Sugar Compared to Placebo in People With Type 2 Diabetes
Date:6/26/2010

seen in patients with elevated blood sugar levels at baseline (HbA1c greater than or equal to 9.0 percent).(1)
  • The proportion of patients reporting at least one adverse event (AE) was similar for both groups (52.4 percent linagliptin; 58.7 percent placebo).  Hypoglycemia occurred in one patient in each of the groups (0.3 percent linagliptin; 0.6 percent placebo).  Serious AEs were reported in both groups (3.0 percent linagliptin; 4.2 percent placebo) but were not determined by the investigators to be drug related.(1)
  • Patients who received linagliptin as an add-on to metformin with baseline HbA1c greater than or equal to 7.0 percent were more likely to achieve an HbA1c <7.0 percent than those receiving metformin + placebo (26.2 percent versus 9.2 percent, p=0.0001).(2)
    • Linagliptin + metformin showed a statistically significant change in placebo-adjusted postprandial glucose (PPG) levels of -67.1 mg/dl compared to placebo + metformin (p<0.0001).
    • The proportion of patients reporting at least one AE was similar for both groups (52.8 percent linagliptin; 55.4 percent placebo).  Hypoglycemia occurred in five placebo patients (2.8 percent) and three linagliptin patients (0.6 percent), two of which were considered drug-related by the investigator.(2)
  • Patients who received linagliptin as add-on to metformin and sulfonylurea with baseline HbA1c greater than or equal to 7.0 percent were significantly more likely to achieve a target HbA1c  less than or equal to 7.0 percent when treated with linagliptin (29.2 percent) compared to placebo (8.1 percent, p<0.0001).(3)
    • The proportion of patients reporting a severe AE in the linagliptin and placebo groups was 2.4 percent and 1.5 percent
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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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