UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015638 |
|---|---|
| Receipt number | R000018174 |
| Scientific Title | The efficacy of swicthing from sulfonyl urea to the combination therapy with mitiglinide and voglibose on diurnal variation on glycemic control and endothelial function in patients with type 2 diabetes |
| Date of disclosure of the study information | 2014/11/12 |
| Last modified on | 2017/02/04 12:26:44 |
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Basic information
Public title
The efficacy of swicthing from sulfonyl urea to the combination therapy with mitiglinide and voglibose on diurnal variation on glycemic control and endothelial function in patients with type 2 diabetes
Acronym
The effect of combination therapy with mitiglinide and voglibose on endothelial function in patients with type 2 diabetes
Scientific Title
The efficacy of swicthing from sulfonyl urea to the combination therapy with mitiglinide and voglibose on diurnal variation on glycemic control and endothelial function in patients with type 2 diabetes
Scientific Title:Acronym
The effect of combination therapy with mitiglinide and voglibose on endothelial function in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether switching from sulfonyl urea to the combination therapy with glinide and alpha-glucosidase inhibitor could improve diurnal glycemic control and endothelial dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in FMD, measured by B-mode ultrasound, after 12 weeks
Key secondary outcomes
The change in diurnal glycemic control assessed by continuous glucose monitoring after 12 weeks
The change in HbA1c after 12 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The combination theraphy with 30 mg of mitiglinide and 0.6 mg of voglibose
Interventions/Control_2
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
Type 2 diabetic patients treated with low dose of sulfonyl urea
Glimepiride/Glibenclamide/Gliclazide equal to or lower than 1 mg/1.25 mg/20 mg per day
HbA1c; 6.5 - 7.5%
Key exclusion criteria
Patients treated with alphaGIs or glinides or insulin.
Patients with infection, malignancy, severe liver, renal dysfuction.
Pregnant patients.
Patients who are unable to be responsible for informed concent due to dementia or impaired consciousness.
Patients with past history of intestinal obstruction.
Patients who has stared a new regimen of treatment for diabetes within 3 month prior to the registration of this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-5803-5216
bouchi.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-5803-5216
Homepage URL
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
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
| 2014 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The switching from SUs to mitiglinide/voglibose significantly improved the glucose variability and endothelial function.
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
| 2014 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 12 | 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
| 2014 | Year | 11 | Month | 08 | Day |
Last modified on
| 2017 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018174
