UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPIKE Sub Study -
Title of the study (Brief title)	Study of Effects of Sitagliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPIKE Sub Study -
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effects of glucose-lowering therapy with a DPP-4 inhibitor (Sitagliptin) on the progression of arteriosclerosis will be investigated in clinical cases based on comparison with a conventional treatment group without DPP-4 inhibitor treatment through analyses of existing data from "Study of Preventive Effects of Sitagliptin on Diabetic Atherosclerosis" (observation period completed, data fixed) in this study. A surrogate marker of cardiovascular events, the semi-quantitative index of carotid artery wall tissue characterization, gray-scale median (GSM) will be measured, and the inhibition of arteriosclerosis progression will be compared.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Amount of change in gray-scale median (GSM) during the 2-year observation period
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria are included in this study. 1. Patients with type 2 diabetes (HbA1c [JDS value] of 6.6% or above) who do not show achievement of the target for glycemic control defined in the "Treatment Guide for Diabetes 2010" despite the three or more months of insulin therapy* (one to four injections per day during treatment with rapid-acting, ultra-rapid-acting, long-acting, intermediate-acting, or mixed insulin) or insulin therapy combined with oral diabetic agents other than DPP-4 inhibitors. Those who had previously used DPP-4 inhibitors but have not taken them for the recent twelve or more weeks are also included. 2. Patients aged 30 or older and younger than 80 years old (males and females) 3. Patients who have provided written consent to participate in the study *Excluding CSII
Key exclusion criteria	Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with type 1 or secondary diabetes 2. Patients with severe infections, pre-/post-operative status, or serious injuries 3. Patients with previous events of myocardial infarction, angina pectoris, stroke, or cerebral infarction 4. Patients complicated with diabetic retinopathy requiring retinal photocoagulation or crystalline lens surgery, or those who have undergone these treatments within the last one year 5. Patients with moderate or more severe renal dysfunction (serum creatinine [mg/dL] > 1.4 [male] or > 1.2 [female]) 6. Patients with severe liver dysfunction (AST: 100 IU/l or above) 7. Patients with moderate or more severe heart failure (NYHA [New York Heart Association] class of III or above) 8. Patients who are prescribed with incretin-based agents, including other DPP-4 inhibitors at the time of commencement of the study 9. Patients taking diabetic medicines, etc., that are prohibited for combination with incretin-based agents including DPP-4 inhibitors, by health insurance, at the study initiation 10. Patients who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant 11. Patients with previous hypersensitivity to the investigated drug 12. Other patients determined ineligible by an investigator
Target sample size	274

Research contact person
Name of lead principal investigator	Naoto Katakami
Organization	Osaka University Graduate School of Medicine
Division name	Department of Metabolic Medicine
Address	2-2 Yamadaoka, Suita-shi, Osaka
TEL	06-6879-3732
Email	katakami@endmet.med.osaka-u.ac.jp

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL	03-3295-1350
Homepage URL
Email	takayama@soiken.com

Sponsor
Institute	Department of Metabolic Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 05 Day
Anticipated trial start date	2016 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a retrospective study which analyzes the existing data of patients who were enrolled in the "Sitagliptin Prospective study of Intima media thickness Evaluation" (SPIKE study) UMIN000007396 starting on February 1st, 2012 (observation period has completed, data are fixed). Data are evaluated for the treatment effectiveness of sitagliptin to suppress the progression of diabetic atherosclerosis.

Management information
Registered date	2017 Year 08 Month 15 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032810