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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005311
Receipt No. 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

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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
Institute Juntendo University Graduate School of Medicine
Institute
Department

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
URL(English) https://upload.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


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