12 Nov 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Recruitment of patients for CAROLINA (cardiovascular outcome study of Linagliptin versus Glimepiride in patients with type 2 diabetes) by Boehringer Ingelheim and Eli Lilly has been completed. Linagliptin is currently the only DPP-4 inhibitor that is being compared to an active comparator in a long-term prospective cardiovascular (CV) outcome study.
"The impact of diabetes treatment options on CV complications is not well understood. This poor understanding poses a challenge for treating physicians given the high level of cardiovascular co-morbidity in type 2 diabetes patients," said professor Klaus Dugi, corporate senior vice president, medicine, Boehringer Ingelheim.
"CAROLINA will close the scientific gap in our understanding of long-term cardiovascular outcomes with linagliptin and glimepiride. This study illustrates our commitment to provide a strong scientific foundation for the best treatment options," he added.
The study includes over 6,000 patients in 43 countries at more than 670 sites across the globe. The aim of the study is to investigate and compare the long term impact of treatment with linagliptin and glimepiride on CV morbidity and mortality over a period of about six-to-seven years. In addition, 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 hypoglycaemia.
The primary endpoint of CAROLINA will be time to the first occurrence of either, CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for unstable angina pectoris. The study is expected to complete in 2018.