UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011148 |
|---|---|
| Receipt number | R000011265 |
| Scientific Title | The effect and safety of single tablet of fixed dose mitiglinide and voglibose when changed from DPP-4 inhibitor |
| Date of disclosure of the study information | 2013/07/09 |
| Last modified on | 2015/07/08 09:12:14 |
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Basic information
Public title
The effect and safety of single tablet of fixed dose mitiglinide and voglibose when changed from DPP-4 inhibitor
Acronym
The effect and safety of single tablet of fixed dose mitiglinide and voglibose
Scientific Title
The effect and safety of single tablet of fixed dose mitiglinide and voglibose when changed from DPP-4 inhibitor
Scientific Title:Acronym
The effect and safety of single tablet of fixed dose mitiglinide and voglibose
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Both mitiglinide and voglibose are used widely to control postprandial hyperglycemia, which induces inflammation. The objective of this study is to investigate the effect of this fixed dose combination tablet on glycemic control and inflammation in the patients with type 2 diabetes mellitus whose glycemic control is not adequate with DPP-4 inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
8-OHdG, hs-CRP, HbA1c(NGSP), glycoalbumin, 1,5-AG
Key secondary outcomes
QOL of the patients
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of single tablet of fixed dose mitiglinide (10 mg) and voglibose (0.2 mg)
Interventions/Control_2
Administration of DPP-4 inhibitor
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
Patients with type 2 diabetes mellitus whose HbA1c(NGSP) are more than 6.8% on DPP-4 inhibitor treatment more than 3 months.
Key exclusion criteria
Type 1 diabetes mellitus
Women who are or might be pregnant
Target sample size
30
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, Shinjuku-ku, Tokyo
TEL
03-5363-3797
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, Shinjuku-ku, Tokyo
TEL
03-5363-3797
Homepage URL
tana176k@a7.keio.jp
Sponsor or person
Institute
Department of Internal Medicine, School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2013 | Year | 07 | Month | 09 | 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
| 2012 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 24 | 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
| 2013 | Year | 07 | Month | 08 | Day |
Last modified on
| 2015 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011265
