UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005311
Receipt number R000006261
Scientific Title Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis
Date of disclosure of the study information 2011/03/25
Last modified on 2016/03/25 15:14:36

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Basic information

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

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Juntendo University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Osaka University Graduate School of Medicine

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

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)


Other administrative information

Date of disclosure of the study information

2011 Year 03 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name