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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009947
Receipt No. R000011485
Scientific Title Comparison of effect on inflammation and Oxidative stress with Vildagliptin , Nateglinide versus Glimepiride
Date of disclosure of the study information 2013/03/01
Last modified on 2016/02/23

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Basic information
Public title Comparison of effect on inflammation and Oxidative stress with Vildagliptin , Nateglinide versus Glimepiride
Acronym and Oxidative stress(VIOS) study-
Scientific Title Comparison of effect on inflammation and Oxidative stress with Vildagliptin , Nateglinide versus Glimepiride
Scientific Title:Acronym and Oxidative stress(VIOS) study-
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of effect on inflammation and Oxidative stress with Vildagliptin, Nateglinide versus Glimepiride for type 2 diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes surrogate marker(inflammation and oxidative stress) after 3 month of treatment
Key secondary outcomes glycemic control and lipid metabolism, functon of their liver and kidney, sefety evaluation after 3 month of treatment

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
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Glimepiride 1mg/day
Interventions/Control_2 Vildagliptin 100mg/day
Interventions/Control_3 Nateglinide 270mg/day
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes treated by diet and exercise, or arufa-GI.
1)arufa-GI treatment for at least 1 month was not changed dosage.
2)HbA1c 7.0-8.0%(NGSP)
3)age>=20
Key exclusion criteria 1)type 1 diabetes, 2)past history including severe ketosis, diabetic coma or pre-coma wihtin 6 monthes prior to this trial, 3)severe infection, perioperative period, severe trauma, 4) hepatic dysfunction, 5)renal dysfunction, 6)heart failure, 7)oral mediacation except arufa-GI or insulin treatment, 8)steroid treatment, 9)BMI>=28, 10)unstable plasma glucose control(HbA1c>=0.5%/month), 11)pregnant, intention of becoming pregnant, 12)history of anaphylaxis of DPP-4 inhibitor and insulin secretion related drugs, 13)Any other condition which the attending physician feels would interfere with the trail participation
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Shikata
Organization Okayama University Hospital
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-6510
Email shikata@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo kodera
Organization Okayama University Hospital
Division name Center for Innovative Clinical Medicine
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama
TEL 086-235-6510
Homepage URL
Email kodera@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Novartis farma
Organization
Division
Category of Funding Organization Profit organization
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 岡山大学病院(岡山県)、姫路赤十字病院(兵庫県)、佐藤病院(岡山県)、高梁中央病院(岡山県)、岡山紀念病院(岡山県)、因島総合病院(広島県)、おさふねクリニック(岡山県)、はしもとじんクリニック(広島県)、落合病院(岡山県)、中国中央病院(広島県)、岡山労災病院(岡山県)、岡山赤十字病院(岡山県)、津山中央病院(岡山県)、心臓病センター榊原病院(岡山県)、岡山済生会病院(岡山県)、金光病院(岡山県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 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 Terminated
Date of protocol fixation
2013 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 01 Day
Last follow-up date
2016 Year 02 Month 23 Day
Date of closure to data entry
2016 Year 02 Month 23 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 04 Day
Last modified on
2016 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011485

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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