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Linagliptin Demonstrated Significant HbA1c Reduction in Elderly People With Type 2 Diabetes With Inadequate Glycemic Control
Date:8/15/2013

drugs (i.e. metformin and/or sulfonylurea and/or basal insulin). The primary endpoint was change in HbA1c from baseline (7.8 percent for linagliptin versus 7.7 percent for placebo) to week 24. Key results from the study showed that the mean change from baseline in HbA1c  with linagliptin was -0.64 percent (p<0.0001) after 24 weeks, which showed superiority versus placebo, adjusted for a mean 0.04 percent HbA1C increase for placebo . In addition, analysis of a secondary endpoint showed that the placebo-adjusted mean reduction in fasting plasma glucose from baseline with linagliptin was -20.7 mg/dL (-1.15 mmol/L; p<0.0001). 

The percentage of people with any adverse event was the same in both treatment groups (75.9 percent). Common adverse events included hypoglycemia (low blood glucose; 22.8 percent and 16.5 percent for linagliptin and placebo, respectively), nasopharyngitis (common cold; 10.5 percent in the linagliptin arm and 8.9 percent on placebo), diarrhea (5.6 percent in the linagliptin arm and 2.5 percent on placebo), hyperglycemia (high blood glucose; 5.6 percent and 10.1 percent for linagliptin and placebo, respectively), back pain (7 percent for linagliptin), fall (4.3 percent and 2.5 percent for linagliptin and placebo, respectively) and urinary tract infection (4.3 percent in the linagliptin arm and 6.3 percent on placebo). One patient per group had a drug-related adverse event leading to discontinuation of the study.  Investigator-defined hypoglycemia occurred in 24.1 percent of the linagliptin group and 16.5 percent of the placebo group.

"Elderly people with type 2 diabetes have different challenges managing their blood sugar levels," said Christophe Arbet-Engels, MD, PhD, vice president, metabolic clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "This study shows linagliptin may help to reduce blood sugar levels in elderly people with inadequat
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SOURCE Eli Lilly and Company; Boehringer Ingelheim
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