UMIN-CTR Clinical Trial

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

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Amount of change in gray-scale median (GSM) during the 2-year observation period

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Metabolic Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name

Organization

Non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2015

Year

11

Month

27

Day

Last modified on

2017

Year

11

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023037