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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009714
Receipt No. R000009936
Scientific Title Alogliptin protects Cardiovascular diesase by modurating micro-RNA for diabetis patients
Date of disclosure of the study information 2013/01/07
Last modified on 2014/08/07

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Basic information
Public title Alogliptin protects Cardiovascular diesase by modurating micro-RNA for diabetis patients
Acronym Alogliptin protects Cardiovascular diesase by modurating micro-RNA for diabetis patients
Scientific Title Alogliptin protects Cardiovascular diesase by modurating micro-RNA for diabetis patients
Scientific Title:Acronym Alogliptin protects Cardiovascular diesase by modurating micro-RNA for diabetis patients
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The influence of additional theraphy by a DPP-4 inhibitor (alogliptin benzoate) tretment on protection to cardiovascular disease will be investigated in type 2 diabetis patients on comparison with an alpha-glucosidase inhibitor (Acarbose) treatment group. The mechanizum will be analyzed by the changs of serum micro-RNA level.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes in the serum micro-RNA during a 6-month treatment period
Key secondary outcomes The changes of following data
1.FBS, HbA1c
2.urinary micro albmin
3.BUN, Cr, Cystatine C
4.the grade of diebetis retinopaty

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DPP4 (Alogliptin) treatment group;
Clinical investigators will initiate alogliptin treatment in addition to the existing single medication. Treatment will be continued to achieve the target value specified in the diabetes treatment guidelines.
Interventions/Control_2 alpha-glucosidase inhibitor treatment group;
Clinical investigators will initiate alpha-glucosidase inhibitor (Acarbose) treatment in addition to the existing single medication. 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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. twenty years of age or older
(regardless of gender)
2.Type 2 diabetes patients (HbA1c (NGSP value) higher then 6.2% and below 8.4%) in whom the target of blood glucose control specified in the 2010 diabetes treatment guidelines is not achieved despite the single therapeutic drugs for diabetes other than a DPP-4 inhibitor being performed for 3 months or longer
3.Written consent for participation in the study
Key exclusion criteria Patients meeting one of the following conditions will be excluded:
1.Under treatment with a thiazolinean, dual or more diabetis drugs, other DPP-4 inhibitors or insulin at the time of study initiation
2. Type 2 and secondary diabetes
3. Severe infectious disease, before or after surgery, and severe trauma
4. Events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction
5. Moderate renal dysfunction
(Serum creatinine (mg/dL): male, 1.4<; female, 1.2<)
6. Severe liver dysfunction (AST: 100 IU/l or higher)
7. Moderate or severer heart failure)
(NYHA/New York Heart Association stage III or severer)
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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MASATOSHI KAWANA
Organization Aoyama Hospital, Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 2-7-13 Kita-Aoyama, Minato-ku, Tokyo
TEL +81-35411-8111
Email mkawanahij@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name HARUKI SEKIGUCHI
Organization Aoyama Hospital, Tokyo Women's Medical University
Division name Cardiology
Zip code
Address 2-7-13 Kita-Aoyama, Minato-ku, Tokyo
TEL +81-35411-8111
Homepage URL
Email gucci_0418@yahoo.co.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute of Geriatrics Tokyo Women's Medical University
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
2013 Year 01 Month 07 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 Enrolling by invitation
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 20 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
2013 Year 01 Month 07 Day
Last modified on
2014 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009936

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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