UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009714 |
|---|---|
| Receipt number | 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 18:57:29 |
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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
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
gucci_0418@yahoo.co.jp
Sponsor or person
Institute
Tokyo Women's Medical University
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
Institute of Geriatrics Tokyo Women's Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009936
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