title: Rationale, design, and baseline characteristics of a trial for the prevention of diabetic atherosclerosis using a DPP-4 inhibitor: the Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A).
abstract: OBJECTIVE
  Alogliptin, an efficacious inhibitor of DPP-4 that improves glycemic control, as well as the pancreatic beta-cell function, is now increasingly used to accomplish glycemic targets in type 2 diabetic patients. Interestingly, recent experimental studies have shown that alogliptin exerts anti-atherosclerotic effects in GLP-1-dependent and -independent manners. The aim of the present ongoing study is to investigate the preventive effects of alogliptin on the progression of atherosclerosis in type 2 diabetic subjects using the carotid intima-media thickness (IMT), an established marker of cardiovascular disease.
  
  
  RESULTS
  The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A) is a prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study. Between March 2011 and March 2012, 341 participants were recruited at 11 clinical sites, and were randomly allocated either to an alogliptin treatment group (172 patients) or a conventional treatment group (169 patients). The primary outcomes are the changes in the maximum and mean IMT of the common carotid artery during a 24-month treatment period, as measured by carotid arterial echography. The secondary outcomes include the changes in glycemic control, parameters related to beta-cell function and diabetic nephropathy, the occurrence of cardiovascular events and adverse events and biochemical measurements reflecting vascular function.
  
  
  CONCLUSIONS
  This is the first study to address the effects of DPP-4 inhibitors on the progression of changes in the carotid IMT, with the patients without DPP-4 inhibitor treatment serving as a control group. The results will be available soon, and these findings are expected to provide clinical data that will be helpful in the prevention of diabetic atherosclerosis and subsequent cardiovascular disease.
authors: Department of Metabolic Medicine, Osaka University Graduate School of Medicine.
authors: Naoto
authors: N
authors: Katakami
authors: Tomoya
authors: T
authors: Mita
authors: Hidenori
authors: H
authors: Yoshii
authors: Tomio
authors: T
authors: Onuma
authors: Hideaki
authors: H
authors: Kaneto
authors: Takeshi
authors: T
authors: Osonoi
authors: Toshihiko
authors: T
authors: Shiraiwa
authors: Keisuke
authors: K
authors: Kosugi
authors: Yutaka
authors: Y
authors: Umayahara
authors: Tsunehiko
authors: T
authors: Yamamoto
authors: Hiroki
authors: H
authors: Yokoyama
authors: Nobuichi
authors: N
authors: Kuribayashi
authors: Hideaki
authors: H
authors: Jinnouchi
authors: Masahiko
authors: M
authors: Gosho
authors: Hirotaka
authors: H
authors: Watada
authors: Iichiro
authors: I
authors: Shimomura
mesh_terms: D000368:Aged; D050197:Atherosclerosis / Q000150:complications / Q000517:prevention & control*; D048909:Diabetes Complications / Q000517:prevention & control*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D014498:Uracil / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D054873:Dipeptidyl-Peptidase IV Inhibitors; D010880:Piperidines; D014498:Uracil; C520853:alogliptin