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Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15.

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

Author information

1
Department of Internal Medicine I, University Hospital Aachen, Aachen, Germany nmarx@ukaachen.de.
2
Dallas Diabetes and Endocrine Center at Medical City and University of Texas, Southwestern Medical Center, Dallas, TX, USA.
3
Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA.
4
Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, ON, Canada University of Toronto, Toronto, ON, Canada.
5
Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands.
6
The Biostatistics Center, The George Washington University, Rockville, MD, USA.
7
Department of Biostatistics, Wake Forest Baptist Medical Center, Winston-Salem, NC, USA.
8
Boehringer Ingelheim, Biberach, Germany.
9
Boehringer Ingelheim, Ingelheim, Germany.
10
Boehringer Ingelheim, Bruxelles, Belgium.
11
Boehringer Ingelheim, Bracknell, UK.
12
Boehringer Ingelheim, Asker, Norway.

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.

KEYWORDS:

Type 2 diabetes; cardiovascular complications; dipeptidyl-peptidase-4 inhibitor; macrovascular; sulphonylurea

PMID:
25780262
PMCID:
PMC4390606
DOI:
10.1177/1479164115570301
[Indexed for MEDLINE]
Free PMC Article

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