Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®).
Diabetes and Vascular Disease Research
Blood Glucose--drug effects; Cardiovascular Diseases--prevention & control; Diabetes Mellitus, Type 2--drug therapy; Dipeptidyl Peptidase 4--metabolism; Dipeptidyl-Peptidase IV Inhibitors--therapeutic use; Incretins--therapeutic use; Linagliptin--therapeutic use; Research Design; Sulfonylurea Compounds--therapeutic use
CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (NCT01243424) is an ongoing, randomized trial in subjects with early type 2 diabetes and increased cardiovascular risk or established complications that will determine the long-term cardiovascular impact of linagliptin versus the sulphonylurea glimepiride. Eligible patients were sulphonylurea-naïve with HbA1c 6.5%-8.5% or previously exposed to sulphonylurea (in monotherapy or in a combination regimen <5 >years) with HbA1c 6.5%-7.5%. Primary outcome is time to first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina. A total of 631 patients with primary outcome events will be required to provide 91% power to demonstrate non-inferiority in cardiovascular safety by comparing the upper limit of the two-sided 95% confidence interval as being below 1.3 for a given hazard ratio. Hierarchical testing for superiority will follow, and the trial has 80% power to demonstrate a 20% relative cardiovascular risk reduction. A total of 6041 patients were treated with median type 2 diabetes duration 6.2 years, 40.0% female, mean HbA1c 7.2%, 66% on 1 and 24% on 2 glucose-lowering agents and 34.5% had previous cardiovascular complications. The results of CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes may influence the decision-making process for selecting a second glucose-lowering agent after metformin in type 2 diabetes.
© The Author(s) 2015.
Marx, N., Rosenstock, J., Kahn, S. E., Zinman, B., Kastelein, J. J., Lachin, J. M., Espeland, M. A., Bluhmki, E., Mattheus, M., Ryckaert, B., Patel, S., Johansen, O. E., & Woerle, H. (2015). Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®).. Diabetes and Vascular Disease Research, 12 (3). http://dx.doi.org/10.1177/1479164115570301