PMID- 24607023
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140314
LR  - 20240321
IS  - 1758-5996 (Print)
IS  - 1758-5996 (Electronic)
IS  - 1758-5996 (Linking)
VI  - 6
IP  - 1
DP  - 2014 Mar 10
TI  - 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).
PG  - 35
LID - 10.1186/1758-5996-6-35 [doi]
AB  - 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.
FAU - Mita, Tomoya
AU  - Mita T
AD  - Department of Metabolism & Endocrinology, Juntendo University Graduate School of 
      Medicine, Hongo 2-1-1, Bunkyo-ku, Tokyo 113-8421, Japan. tom-m@juntendo.ac.jp.
FAU - Katakami, Naoto
AU  - Katakami N
FAU - Shiraiwa, Toshihiko
AU  - Shiraiwa T
FAU - Yoshii, Hidenori
AU  - Yoshii H
FAU - Onuma, Tomio
AU  - Onuma T
FAU - Kuribayashi, Nobuichi
AU  - Kuribayashi N
FAU - Osonoi, Takeshi
AU  - Osonoi T
FAU - Kaneto, Hideaki
AU  - Kaneto H
FAU - Kosugi, Keisuke
AU  - Kosugi K
FAU - Umayahara, Yutaka
AU  - Umayahara Y
FAU - Yamamoto, Tsunehiko
AU  - Yamamoto T
FAU - Matsumoto, Kazunari
AU  - Matsumoto K
FAU - Yokoyama, Hiroki
AU  - Yokoyama H
FAU - Tsugawa, Mamiko
AU  - Tsugawa M
FAU - Gosho, Masahiko
AU  - Gosho M
FAU - Shimomura, Iichiro
AU  - Shimomura I
FAU - Watada, Hirotaka
AU  - Watada H
LA  - eng
PT  - Journal Article
DEP - 20140310
PL  - England
TA  - Diabetol Metab Syndr
JT  - Diabetology & metabolic syndrome
JID - 101488958
PMC - PMC3973974
EDAT- 2014/03/13 06:00
MHDA- 2014/03/13 06:01
PMCR- 2014/03/10
CRDT- 2014/03/11 06:00
PHST- 2014/01/16 00:00 [received]
PHST- 2014/02/26 00:00 [accepted]
PHST- 2014/03/11 06:00 [entrez]
PHST- 2014/03/13 06:00 [pubmed]
PHST- 2014/03/13 06:01 [medline]
PHST- 2014/03/10 00:00 [pmc-release]
AID - 1758-5996-6-35 [pii]
AID - 10.1186/1758-5996-6-35 [doi]
PST - epublish
SO  - Diabetol Metab Syndr. 2014 Mar 10;6(1):35. doi: 10.1186/1758-5996-6-35.