Boehringer, Lilly (LLY) Completes Enrollment in CAROLINA
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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. 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.
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. The study is expected to complete in 2018.
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. 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.
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. The study is expected to complete in 2018.
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