Title

Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®).

Document Type

Journal Article

Publication Date

5-1-2015

Journal

Diabetes and Vascular Disease Research

Volume

12

Issue

3

Inclusive Pages

164-174

DOI

10.1177/1479164115570301

Keywords

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

Abstract

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.

Peer Reviewed

1

Open Access

1