UMIN-CTR Clinical Trial

Public title

Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis

Acronym

Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis

Scientific Title

Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis

Scientific Title:Acronym

Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The influence 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. A surrogate marker of cardiovascular events, the carotid artery intima-media thickness (IMT), will be measured, and the inhibition of arteriosclerosis progression will be compared. At the same time, the influences on cardiovascular function and blood biomarkers will also be investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in the IMT value (mean and max IMT) during a 24-month treatment period measured by carotid arterial echography

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Alogliptin treatment group (Group A);
Clinical investigators will initiate alogliptin treatment following the allocation in the alogliptin treatment group. Treatment will be continued to achieve the target value specified in the diabetes treatment guidelines.

Interventions/Control_2

Conventional treatment group (Group C);
Clinical investigators will continue conventional treatment using drugs other than the DPP-4 inhibitor in the conventional treatment group. Treatment will be continued to achieve the target value specified in the diabetes treatment guidelines.

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

1) Type 2 diabetes patients (HbA1c (JDS value) higher then 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 meeting one of the following conditions will be excluded:
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

324

Name of lead principal investigator

1st name
Middle name
Last name	HIROTAKA WATADA

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

mita0623@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Tomoya Mita

Organization

Juntendo University Graduate School of Medicine

Division name

Department of Medicine, Metabolism and Endocrinology

Zip code

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL

Email

mita0623@yahoo.co.jp

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Osaka University Graduate School of Medicine

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

横山内科クリニック（北海道）
秋田赤十字病院（秋田県）
那珂記念クリニック（茨城県）
順天堂大学付属浦安病院（千葉県）
順天堂東京江東高齢者医療センター（東京都）
順天堂大学付属順天堂医院（東京都）
大阪大学医学部付属病院（大阪府）
大阪警察病院（大阪府）
大阪府立急性期・総合医療センター（大阪府）
関西労災病院（大阪府）
陣内病院（熊本県）
三咲内科クリニック（千葉県）
白岩内科医院（大阪府）

Date of disclosure of the study information

2011

Year

03

Month

25

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://care.diabetesjournals.org/content/39/1/139.long

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

2011

Year

03

Month

18

Day

Date of IRB

Anticipated trial start date

2011

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

03

Month

25

Day

Last modified on

2016

Year

03

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006261