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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008051
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Third Department of Internal Medicine, Tokyo Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009481

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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