Abstract
BackgroundPatients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. There is evidence that in patients with coronary artery disease (CAD), about 35 % suffer from manifest T2DM. Early glucose-lowering intervention in subjects with T2DM has been demonstrated to be beneficial in terms of cardiovascular risk reduction. But thus far, no data are available regarding investigating the impact of linagliptin treatment in patients with early diabetes on cardiovascular endpoints or surrogate parameters. Therefore, the aim of this study is to investigate the effects of linagliptin in CAD patients with early T2DM on various cardiovascular surrogate measurements including mechanical and biochemical endothelial function assessments.Methods/designForty-two subjects with early diabetes and CAD are included in this investigator-driven, randomized, placebo-controlled, double-blind, phase IV, single-center study. Participants will be randomized to receive either linagliptin (5 mg) administered once daily per os or placebo for 12 weeks. Before and after the intervention, evaluation of endothelial function (flow-mediated dilatation and biochemical biomarkers) and a Meal Tolerance Test are performed.DiscussionCardiovascular surrogate parameters, such as endothelial function, are able to provide insights into the potential mechanisms of the cardiovascular effects of antihyperglycemic agents. Currently ongoing trials do not specifically focus on early diabetes as a target of intervention and we therefore believe that our study will contribute to a better understanding of the cardiovascular effects of dipeptidylpeptidase-4 (DPP-4) inhibitors in early diabetes.Trial registration NCT02350478. Registered 26 January 2015. Protocol date/version 24 October 2014/version 2.4EudraCT number: 2013-000330-35Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1627-3) contains supplementary material, which is available to authorized users.
Highlights
Patients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications
Ongoing trials do not focus on early diabetes as a target of intervention and we believe that our study will contribute to a better understanding of the cardiovascular effects of dipeptidylpeptidase-4 (DPP-4) inhibitors in early diabetes
Patients with type 2 diabetes (T2DM) are at increased risk of macrovascular events as well as of microvascular complications [1]. It is well-known that the pathophysiologic process of Type 2 diabetes mellitus (T2DM) starts many years before the diagnosis can be made on the basis of elevated fasting blood glucose or pathologic glucose tolerance evaluation [2], and in particular the data from the United Kingdom Prospective Diabetes Study (UKPDS) and the UKPDS post-trial monitoring highlighted the importance of an early glucose-lowering intervention in patients with T2DM for the reduction of future microvascular and macrovascular complications [3, 4]
Summary
Patients with type 2 diabetes (T2DM) are at increased risk for macrovascular events as well as for microvascular complications. Glucose-lowering intervention in subjects with T2DM has been demonstrated to be beneficial in terms of cardiovascular risk reduction. Patients with type 2 diabetes (T2DM) are at increased risk of macrovascular events as well as of microvascular complications [1] It is well-known that the pathophysiologic process of T2DM starts many years before the diagnosis can be made on the basis of elevated fasting blood glucose or pathologic glucose tolerance evaluation [2], and in particular the data from the United Kingdom Prospective Diabetes Study (UKPDS) and the UKPDS post-trial monitoring highlighted the importance of an early glucose-lowering intervention in patients with T2DM for the reduction of future microvascular and macrovascular complications [3, 4]. Two outcome trials with linagliptin (CAROLINA [14] and CARMELINA - NCT01897532) are underway, of which the former is performed in subjects with early diabetes
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