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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019951
Receipt No. R000023037
Scientific Title Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM) - SPEAD-A Sub Study -
Date of disclosure of the study information 2015/11/27
Last modified on 2017/11/28

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Basic information
Public title Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPEAD-A Sub Study -
Acronym Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPEAD-A Sub Study - [SPEAD-A GSM study]
Scientific Title Study of Effects of Alogliptin on Diabetic Atherosclerosis by Gray-Scale Median (GSM)
- SPEAD-A Sub Study -
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Naoto Katakami
Organization Osaka University Graduate School of Medicine
Division name Department of Metabolic Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 03-3295-1350
Email takayama@soiken.com

Public contact
1st name of contact person
1st name
Middle name
Last name Hiroki Takayama
Organization Soiken Inc.
Division name Clinical Study Support Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 09 Month 26 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000023037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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