Linagliptin Controlled Type II Diabetes In Asian Clinical Trials
Tech & Pharma
June 24, 2013
Two phase III clinical studies show that linagliptin improved blood glucose control in Asian adults with type II diabetes.
AsianScientist (Jun. 24, 2013) – Results from two phase III clinical studies by Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company show that linagliptin, as monotherapy and in combination with metformin, improved blood glucose control in Asian adults with type II diabetes.
The study data from two randomized phase III clinical trials were presented at the American Diabetes Association 73rd Scientific Sessions®.
A combination of both genetic and environmental influences is attributed to the higher rate of type II diabetes in people of Asian descent. If the current trend continues, it is estimated that more than 60 percent of the world’s diabetes population will be in Asia by 2030.
“The results of these two studies continue to support use of linagliptin in Asian adults with type II diabetes,” said Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Adults of Asian descent with type II diabetes tend to develop the condition at a younger age than those from Western populations, regardless of their body weight.”
In the first study, linagliptin monotherapy demonstrated a 0.68 percent reduction in HbA1c (from a mean baseline HbA1c of 7.95 percent) at 24 weeks among Asian patients from China, Malaysia, and the Philippines, compared with a reduction of 0.18 percent (from a mean baseline HbA1c of 8.09 percent) in the placebo group. In a pre-defined subgroup of patients with a baseline HbA1c of at least 8.5 percent, treatment with linagliptin resulted in a placebo-adjusted reduction in HbA1c of 0.91 percent (p < 0.0001) at 24 weeks. HbA1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.
Results from the second study showed an HbA1c reduction of 0.66 percent (from a mean baseline HbA1c of 7.99 percent) at 24 weeks among Asian patients from China, Malaysia, and the Philippines who received linagliptin added to metformin at 24 weeks, versus a reduction of 0.14 percent (from a mean baseline HbA1c of 8.00 percent) among patients receiving placebo added to metformin.
Linagliptin, which is marketed as Tradjenta® (linagliptin) tablets in the U.S., is a once-daily 5 mg tablet used along with diet and exercise to improve glycemic control in adults with type II diabetes. Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.
Source: Eli Lilly and Company; Boehringer Ingelheim Pharmaceuticals, Inc.
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