UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009947 |
|---|---|
| Receipt number | 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 10:49:57 |
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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
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
kodera@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011485
