"Linagliptin is primarily excreted unmetabolized via bile and gut, meaning no dose adjustment is needed in adult patients with kidney or liver impairment," said Prof. Anthony Barnett, professor of medicine and clinical director of the Department of Diabetes and Endocrinology, Heart of England NHS Foundation Trust, Birmingham, UK. "This means that linagliptin is available at only one dose."
The approval of linagliptin in Europe was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes. Included in the program were placebo-controlled studies evaluating linagliptin as monotherapy(4) and in combination with the commonly prescribed oral antihyperglycemic medications metformin and/or sulfonylurea.(2,5-6) In two monotherapy studies, linagliptin showed a statistically significant mean difference in A1C from placebo of -0.6 to -0.7 percent.(3-4) In patients who were not adequately controlled on metformin or metformin plus sulfonylurea, the addition of linagliptin also resulted in a statistically significant mean difference in A1C from placebo of -0.6 percent.(2,5) The incidence of hypoglycemia was similar to placebo and weight did not change significantly from baseline.(2,5)
In the pooled analysis of the placebo-controlled trials, the overall incidence of adverse events in patients treated with placebo was similar to that seen with linagliptin (53.8 percent versus 55.0 percent).
The most frequently reported adverse reaction was hypoglycemia observed with the triple combination of linagliptin plus metformin plus sulfonylurea.
"The EU approval of linagliptin marks another major regulatory milestone for the Boehringer Ingelheim and Lilly alliance in diabetes," said Enrique Conterno, president of Lilly Diabetes. "Linagliptin can be an important treatment option for adults living with type 2 diabetes."
|SOURCE Eli Lilly and Company|
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