UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000009809