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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008332
Receipt No. 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

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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
Email 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
Email miwa-t@tokyo-med.ac.jp

Sponsor
Institute The Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009809

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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