UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPEAD-A Sub Study -
Title of the study (Brief title)	Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPEAD-A Sub Study - [SPEAD-A GSM 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 (alogliptin benzoate) 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 Alogliptin 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) Type 2 diabetes patients (HbA1c (JDS value) higher than 5.8% and below 9.0%) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite dietary/exercise therapy or those with concomitant therapeutic drugs for diabetes other than a DPP-4 inhibitor being performed for 3 months or longer, including those after a 12-week or longer withdrawal of previous DPP-4 inhibitor treatment. 2) Thirty years of age or older (regardless of gender) 3) Written consent for participation in the study
Key exclusion criteria	Patients who fall into any of the following criteria are excluded from participating in the study. 1) Type I and secondary diabetes 2) Severe infectious disease, before or after surgery, and severe trauma 3) Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction 4) Moderate renal dysfunction (Serum creatinine (mg/dL): male, 1.4<; female, 1.2<) 5) Severe liver dysfunction (AST: 100 IU/l or higher) 6) Moderate or severer heart failure) (NYHA/New York Heart Association stage III or severer) 7) Under treatment with an incretin preparation, such as other DPP-4 inhibitors, at the time of study initiation 8) Under insulin treatment 9) Under treatment with therapeutic drugs not concomitantly administrable with incretin preparations, such as DPP-4 inhibitors, with regard to national health insurance, at the time of study initiation 10) Pregnant, lactating, and possibly pregnant women and those planning to become pregnant 11) Past medical history of hypersensitivity to investigational drugs 12) Judged as ineligible by clinical investigators
Target sample size	322

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, Osaka
TEL	03-3295-1350
Email	takayama@soiken.com

Public contact
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Clinical Study Support Division
Address	NBF Ogawamachi Building 4F, Kanda Ogawamachi 1-3-1, Chiyoda-ku, Tokyo 101-0052
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	Non
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	2015 Year 11 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 26 Day
Anticipated trial start date	2015 Year 11 Month 01 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 cohort study which analyzes the data of patients who were enrolled in the "Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis" [SPEAD-A] UMIN000005311 starting on March 1st, 2011 (observation period has completed, data are fixed). Gray-scale median (GSM) is evaluated through the images of which are quantified by a computer software.

Management information
Registered date	2015 Year 11 Month 27 Day
Last modified on	2017 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023037