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Phase III Studies Show Linagliptin Improved Blood Glucose Control In Asian Adults With Type 2 Diabetes

RIDGEFIELD, Conn. and INDIANAPOLIS, June 22, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced results from two phase III clinical studies that showed linagliptin in Asian adults, as monotherapy and in combination with metformin, improved blood glucose control in people with type 2 diabetes (T2D) from China, Malaysia and the Philippines. The study data from two randomized phase III clinical trials were presented at the American Diabetes Association 73rd Scientific Sessions ®.

In Asia, the rate of T2D is rapidly increasing. 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. 1 Similarly, in the United States, the rate of T2D in Chinese Americans is much higher than the rate in the Chinese population living in rural China. 2 A combination of both genetic and environmental influences is attributed to the higher rate of T2D in people of Asian descent. 2

"The results of these two studies continue to support use of linagliptin in Asian adults with type 2 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 2 diabetes tend to develop the condition at a younger age than those from Western populations, regardless of their body weight." 1

In the first study, linagliptin monotherapy demonstrated a 0.68 percent reduction in HbA 1c (from a mean baseline HbA 1c 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 HbA 1c of 8.09 percent) in the placebo group (placebo-corrected difference of -0.50 percent; 95 percent confidence interval [CI]: -0.71, -0.28; p<0.0001). In a pre-defined subgroup of patients with a baseline HbA 1c of at least 8.5 percent, treatment with linagliptin resulted in a placebo-adjusted reduction in HbA 1c of 0.91 percent (p<0.0001) at 24 weeks. 3 HbA 1c is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months. 3

Results from the second study showed an HbA 1c reduction of 0.66 percent (from a mean baseline HbA 1c 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 HbA 1c of 8.00 percent) among patients receiving placebo added to metformin (placebo-corrected difference in HbA 1c was -0.52 percent; 95 percent CI: -0.70, -0.34; p<0.0001). [4]

In both studies, the incidence of adverse events (AEs) was similar in each treatment group compared with placebo. The incidence of AEs for linagliptin were 28.0 percent in the monotherapy study and 27.3 percent in the add-on therapy study, and comparable to the placebo arm (28.3 percent and 28.0 percent, respectively). In the monotherapy study, drug-related AEs were reported in 3.0 percent of linagliptin patients and 2.0 percent of placebo patients; in the add-on trial, drug-related AEs were reported in 2.4 percent of linagliptin patients and 0.0 percent of placebo patients. In addition, investigator-defined hypoglycemia occurred in 0.5 percent of linagliptin patients and 0.0 percent of placebo patients in the monotherapy study, and in 1.0 percent of patients in both groups of the add-on study. 3, 4

About the StudiesThe first study was a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of linagliptin monotherapy for 24 weeks in Asian patients with inadequately controlled type 2 diabetes mellitus. The study included a total of 300 patients with T2D from China (n=261), Malaysia (n=22) and the Philippines (n=17). Patients who were treatment naïve or who had been treated with one antihyperglycemic drug were randomized to either linagliptin 5 mg daily or placebo following a 4-week washout period of prior drugs. The primary endpoint was change from baseline in mean HbA 1c after 24 weeks. 3 Mean HbA 1c levels at baseline were 7.95 percent for patients in the linagliptin group and 8.09 percent for patients in the placebo group.

The second study, also a randomized, double-blind, placebo-controlled trial, evaluated the efficacy and safety of linagliptin as add-on therapy to metformin in Asian patients with inadequately controlled type 2 diabetes mellitus. The study included a total of 306 patients with T2D from China (n=265), Malaysia (n=17) and the Philippines (n=24). Antihyperglycemic drugs other than metformin were washed out for 4 weeks prior to randomization to either linagliptin 5mg daily or placebo added to metformin. The primary endpoint of the study was change from baseline in mean HbA 1c after 24 weeks. 4 Mean HbA 1c levels at baseline were 7.99 percent for patients in the linagliptin group and 8.00 percent for patients in the placebo group.

Linagliptin, which is marketed as Tradjenta ® (linagliptin) tablets in the U.S., is a once-daily 5mg tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). If patients have had pancreatitis in the past, it is not known if they have a higher chance of getting pancreatitis while taking linagliptin. Linagliptin is a DPP-4 inhibitor that does not require dose adjustments, regardless of declining renal function or hepatic impairment.

What are TRADJENTA tablets?TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

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