UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008332 |
|---|---|
| Receipt number | R000009809 |
| Scientific Title | Evaluation of effect of Glubes combination tablet on the HbA1c levels and vascular endothelial function |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2019/12/13 16:10:24 |
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Basic information
Public title
Evaluation of effect of Glubes combination tablet on the HbA1c levels and vascular endothelial function
Acronym
EGEF trial
Scientific Title
Evaluation of effect of Glubes combination tablet on the HbA1c levels and vascular endothelial function
Scientific Title:Acronym
EGEF trial
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify how switching from low-dose SU (equivalent to glimepiride <2 mg/day) to Glubes might affect the blood glucose control (especially postprandial hyperglycemia) and vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of FMD (0 and 60 min)
Key secondary outcomes
HbA1c, serum 1,5-AG, serum lipids, blood pressure, weight, safety parameters (hypoglycemia, liver function test abnormalities), insulin level in the meal tolerance test, blood glucose profile, serum MDA-LDL, serum nitrotyrosine, serum IL-6
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study subjects shall be randomly assigned to one of 2 groups, namely, the Glubes combination tablet (MV) group or the glimepiride continuation group, and the clinical course shall be observed for 4 weeks. After 4 weeks, the treatment shall be crossed over, and the clinical course observed for another 4 weeks.
Interventions/Control_2
Study subjects shall be randomly assigned to one of 2 groups, namely, the Glubes combination tablet (MV) group or the glimepiride continuation group, and the clinical course shall be observed for 4 weeks. After 4 weeks, the treatment shall be crossed over, and the clinical course observed for another 4 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients on low-dose SU (equivalent to glimepiride <=2 mg/day) meeting the following criteria.
Eligible patients must meet all of the following criteria.
1)Outpatient
2)Fasting blood glucose less than 140 mg/dL and HbA1c not less than 6.9%(NGSP)
3)Willing to provide consent for participation in the study
Key exclusion criteria
Patients fulfilling any of the following criteria will be excluded.
1)Having some contraindication to use of mitiglinide or voglibose
2)Excessive alcohol intake
3)Severely impaired liver or kidney function
4)Age <=75 years
5)Duration of diabetes >=10 years
6)Use of the study drug, glinide, or AGI within the previous 8 weeks
7)Ongoing treatment with a DPP-4 inhibitor, GLP-1 analog, or insulin
8)Any other condition that may potentially affect the efficacy evaluation
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Odawara |
| Middle name | |
| Last name | Masato |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
1600023
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo 160-0023
TEL
03-3342-6111
odawara@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Miwa |
Organization
Tokyo Medical University
Division name
The Department of Diabetes, Endocrinology and Metabolism
Zip code
1600023
Address
6-7-1 Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
miwa-t@tokyo-med.ac.jp
Sponsor or person
Institute
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical 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
Tokyo Medical University
Address
Nishi-Shinjuku 6-7-1, Shinjuku-ku, Tokyo
Tel
0333426111
kenkyu-s@tokyo-med.ac.jp
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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 03 | 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
| Delay expected |
Results Delay Reason
There were no registered patients
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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2019 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009809
