UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008051 |
|---|---|
| Receipt number | R000009481 |
| Scientific Title | Efficacy of conbination therapy of DPP4-inhibitor and alpha-GI for type-2 diabetes patient. |
| Date of disclosure of the study information | 2012/05/29 |
| Last modified on | 2012/05/29 14:39:07 |
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Basic information
Public title
Efficacy of conbination therapy of DPP4-inhibitor and alpha-GI for type-2 diabetes patient.
Acronym
Efficacy of conbination therapy of DPP4-inhibitor and alpha-GI for type-2 diabetes patient.
Scientific Title
Efficacy of conbination therapy of DPP4-inhibitor and alpha-GI for type-2 diabetes patient.
Scientific Title:Acronym
Efficacy of conbination therapy of DPP4-inhibitor and alpha-GI for type-2 diabetes patient.
Region
| Japan |
Condition
Condition
type-2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate that the rapid synergistic effect of conbination therapy of alogliptin and alpha-glucosidase inhibitor.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changing of blood Glucose,insulin,glucagon,totalGIP,active form GLP1 levels before and 30,60 and 120 min after food intake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
On the first day, each patient receive a dose of alogliptin (25 mg; after a test meal).
Interventions/Control_2
On the second day, each patient receive alogliptin (25 mg; after a meal) and acarbose (100 mg; immediately before a test meal).
Interventions/Control_3
On the third day, each patient receive alogliptin (25 mg; after a test meal) and miglitol (50 mg; immediately before a test meal).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
type-2 diabetes patient
from 20 to 75 years old patient
patients who gave informed consent
Key exclusion criteria
contraindication for taking alogliptin
contraindication for taking acarbose
contraindication for taking miglitol
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Odawara |
Organization
Tokyo Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo 160-0023, Japan
TEL
Homepage URL
Sponsor or person
Institute
Third Department of Internal Medicine, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, Tokyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2012 | Year | 05 | Month | 29 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 25 | 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
| 2012 | Year | 05 | Month | 29 | Day |
Last modified on
| 2012 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009481
