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Diabetology & Metabolic Syndrome
Published in: Diabetology & Metabolic Syndrome 1/2014

Open Access 01-12-2014 | Research

Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)

Authors: Tomoya Mita, Naoto Katakami, Toshihiko Shiraiwa, Hidenori Yoshii, Tomio Onuma, Nobuichi Kuribayashi, Takeshi Osonoi, Hideaki Kaneto, Keisuke Kosugi, Yutaka Umayahara, Tsunehiko Yamamoto, Kazunari Matsumoto, Hiroki Yokoyama, Mamiko Tsugawa, Masahiko Gosho, Iichiro Shimomura, Hirotaka Watada

Published in: Diabetology & Metabolic Syndrome | Issue 1/2014

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Abstract

Background

Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, is currently used to achieve glycemic targets in patients with type 2 diabetes mellitus (T2DM). The addition of DPP-4 inhibitors to ongoing insulin therapy is expected to reduce insulin dosage, leading to a reduction in the frequency of hypoglycaemia and/or weight gain. Recent studies have demonstrated potential anti-atherosclerotic effects for DPP-4 inhibitors. The aim of the present ongoing study is to assess the effects of sitagliptin on the progression of atherosclerosis in patients with insulin-treated T2DM using carotid intima-media thickness (IMT), an established marker of cardiovascular disease.

Methods and Design

The Sitagliptin Preventive study of Intima media thickness Evaluation (SPIKE) is a prospective, randomized, open-label, blinded-endpoint, multicenter, parallel-group, comparative study. Between February 2012 and September 2012, 282 participants who failed to achieve glycemic control despite insulin therapy were recruited at 12 clinics and randomly allocated to the sitagliptin group (n = 142) or the control group (n = 140). Primary outcomes are changes in maximum and mean IMT of the common carotid artery after 24-month treatment period measured by carotid arterial echography. Secondary outcomes include changes in glycemic control, parameters related to beta-cell function and diabetic nephropathy, occurrence of cardiovascular events and adverse events such as hypoglycaemia, and biochemical markers of vascular function.

Discussion

The present study is designed to assess the effects of sitagliptin on the progression of carotid IMT. Results will be available in the near future, and the findings are expected to provide new strategy to prevent atherosclerosis in patients with insulin-treated T2DM.

Clinical Trial Registration

UMIN000007396
Appendix
Available only for authorised users
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Metadata
Title
Rationale, design, and baseline characteristics of a clinical trial for prevention of atherosclerosis in patients with insulin-treated type 2 diabetes mellitus using DPP-4 inhibitor: the Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE)
Authors
Tomoya Mita
Naoto Katakami
Toshihiko Shiraiwa
Hidenori Yoshii
Tomio Onuma
Nobuichi Kuribayashi
Takeshi Osonoi
Hideaki Kaneto
Keisuke Kosugi
Yutaka Umayahara
Tsunehiko Yamamoto
Kazunari Matsumoto
Hiroki Yokoyama
Mamiko Tsugawa
Masahiko Gosho
Iichiro Shimomura
Hirotaka Watada
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Diabetology & Metabolic Syndrome / Issue 1/2014
Electronic ISSN: 1758-5996
DOI
https://doi.org/10.1186/1758-5996-6-35

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