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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007714
Receipt No. R000009093
Scientific Title The effects of the combination therapy of DPP-4 inhibitor alogliptin and alfa-glucosidase inhibitor on markers of inflammation and oxidative stress - comparison between Acarbose and Voglibose
Date of disclosure of the study information 2012/05/01
Last modified on 2014/01/08

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Basic information
Public title The effects of the combination therapy of DPP-4 inhibitor alogliptin and alfa-glucosidase inhibitor on markers of inflammation and oxidative stress - comparison between Acarbose and Voglibose
Acronym Combination therapy of DPP-4 inhibitor and alfa-glucosidase inhibitor
Scientific Title The effects of the combination therapy of DPP-4 inhibitor alogliptin and alfa-glucosidase inhibitor on markers of inflammation and oxidative stress - comparison between Acarbose and Voglibose
Scientific Title:Acronym Combination therapy of DPP-4 inhibitor and alfa-glucosidase inhibitor
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of the combination therapy of DPP-4 inhibitor and alfa-glucosidase inhibitors, Acarbose and Voglibose, on the markers of oxidative stress or inflammation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Oxitative stress markaer (urinary 8-OHdG, oxidative LDL)
Inflammatory marker (TNF-alfa, hs-CRP)
Key secondary outcomes Postchallenge plasma glucose concentration

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of Acarbose
Interventions/Control_2 Administration of Voglibose
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patients with type 2 diabetes mellitus who gave written informed consent to take part in this clinical study
2. The patients who has been taking DPP-4 inhibitor for more than 3 months and whose HbA1c (JDS) level is 6.5 % or higher.
Key exclusion criteria 1. type 1 diabetes mellitus
2. diabetes ketoacidosis, coma, or pre-coma
3. patients with severe infection, severe trauma, or in perioperative period
4. patients who have allergy to the medicine used in this trial
5.(possible) pregnant women
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masami Tanaka
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3797
Email tana176k@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masami Tanaka
Organization School of Medicine, Keio University
Division name Department of Internal Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL 03-5363-3797
Homepage URL
Email tana176k@a7.keio.jp

Sponsor
Institute Department of Internal Medicine, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd.
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 01 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 04 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 04 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 04 Month 10 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009093

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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