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Cardiovascular Outcome Study On Tradjenta® (linagliptin) Tablets In Adult Patients With Type 2 Diabetes Completes Enrollment

RIDGEFIELD, Conn. and INDIANAPOLIS, Nov. 8, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the clinical trial enrollment of patients for CAROLINA (Cardiovascular Outcome Study of Linagliptin versus Glimepiride in Patients with Type 2 Diabetes) has been completed. Linagliptin is currently the only DPP-4 inhibitor that is being compared to a sulfonylurea in a long-term cardiovascular (CV) outcome study.

Linagliptin, marketed in the U.S. as Tradjenta ®, is a once-daily tablet used along with diet and exercise to improve glycemic control in adults with type 2 diabetes. TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine).

The study includes over 6,000 patients in 43 countries at more than 600 sites around the world. The aim of the study is to investigate and compare the long-term impact on CV morbidity and mortality of treatment with TRADJENTA or glimepiride over a period of about 6–7 years.(1) Additionally, the study will compare secondary measures of efficacy with regard to lowering blood glucose as well as safety parameters, including body weight and the incidence of hypoglycemia in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare the outcome against glimepiride.(1) 

"CAROLINA will evaluate the cardiovascular safety of linagliptin compared to the sulfonylurea glimepiride," said Dr. Julio Rosenstock, Director of the Dallas Diabetes and Endocrine Center at Medical City in Dallas and Principal Investigator of the study. "Sulfonylureas are frequently used add-on therapy to metformin, which is considered the standard first-line therapy. This is the first time a DPP-4 inhibitor is being directly compared to a sulfonylurea in a long-term cardiovascular outcome study."

The primary endpoint of CAROLINA will be timed to the first occurrence of either CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris.(1)   The study is expected to complete in 2018.

"There are limited available data reporting on CV-related comorbidities with current therapies for patients with type 2 diabetes. For the first time, this study has the potential to compare the CV morbidity, mortality and safety of the DPP-4 inhibitor linagliptin to the commonly prescribed sulfonylurea glimepiride," said Christophe Arbet-Engels, MD, PhD, MBA, vice president, metabolic-clinical development and medical affairs, Boehringer Ingelheim. "It is our hope CAROLINA will help us to better understand the effect on cardiovascular outcomes of linagliptin compared to glimepiride, and, therefore, add to the knowledge base  physicians use to decide how to treat their patients."

To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

About CAROLINA Study Design(1)

CAROLINA evaluates the CV safety of linagliptin in comparison to glimepiride in patients with T2D and at increased CV risk.

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