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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005777
Receipt No. R000006829
Scientific Title Effects of alfa glucosidase inhibitors (miglitol, voglibose) on efficacy and safety in type 2 diabetic patients with coronary artery disease.
Date of disclosure of the study information 2011/06/14
Last modified on 2017/06/19

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Basic information
Public title Effects of alfa glucosidase inhibitors (miglitol, voglibose) on efficacy and safety in type 2 diabetic patients with coronary artery disease.
Acronym Clinical study on vascular endothelial function improvement effect using coronary flow reserve (CFR) by alfa GI treatment
Scientific Title Effects of alfa glucosidase inhibitors (miglitol, voglibose) on efficacy and safety in type 2 diabetic patients with coronary artery disease.
Scientific Title:Acronym Clinical study on vascular endothelial function improvement effect using coronary flow reserve (CFR) by alfa GI treatment
Region
Japan

Condition
Condition type 2 diabetes patients with coronary artery disease
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of miglitol and voglibose on vascular endothelial function evaluated by coronary flow reserve(CFR) as primary endpoint in type 2 diabetes patients with coronary artery disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Coronary Flow Reserve
Key secondary outcomes blood glucose, inflammatory marker, Cardiac function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 miglitol 150 mg/day
Interventions/Control_2 voglibose 0.9 mg/day
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 1)Type 2 diabetic patients with coronary artery disease.
2)HbA1c <= 10.0%(JDS) and 1,5AG <=14.0 micro g/mL
Key exclusion criteria 1)type 1 diabetes mellitus
2)patients who develops asymptomatic hypoglycemia (hypoglycemia unawareness) or severe hypoglycemia repeatedly.
3)patients who have serious liver disease (AST and/or ALT are more than 100 IU/L)
4)patients who have serious kidney disease (Serum Cr is more than 2.0 mg/dL)
5)patients who have serious cardiac disease (patients who have apparent heartfailure or myocardial infarction within 6 months)
6)patients who have serious pancreatic disease
7)patients with cancer
8)patients with serious infection, serious traumatic injury, perioperative period
9)patients with serious diabetic complications including progressed neuropathy and proliferative retinopathy
10)Patients with serious ketosis, diabetic coma, pre-coma
11)patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ilus
12)patinets with chronic bowel diseases which have probability to induce malabsorption syndrome
13)patients who has the disease which is deteriorated with increase of gas in bowel
14)patients who have history of gastrectomy
15)patients with lactose intolerance
16)heavy alcohol drinker (patients who drink more than 480 mL of Japanese Sake, 2L of beer, 180 mL of whisky, 360 mL of wine, or 360 mL of Shochu per day)
17)patients under steroid treatment
18)patients who are pregnant, hope to be pregnant, or are in lactation period
19)patients who are not applicable to this study judged by the medical doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Uzui
Organization University of Fukui Faculty of Medical Sciences
Division name Division of cardiovascular Medicine
Zip code
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Fukui 910-1193, Japan.
TEL 0776-61-3111
Email huzui@u-fukui.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Uzui
Organization University of Fukui Faculty of Medical Sciences
Division name Division of cardiovascular Medicine
Zip code
Address 23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Fukui 910-1193, Japan.
TEL 0776-61-3111
Homepage URL
Email huzui@u-fukui.ac.jp

Sponsor
Institute University of Fukui Faculty of Medical Sciences
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 福井大学医学部

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 14 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 Enrolling by invitation
Date of protocol fixation
2011 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 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
2011 Year 06 Month 14 Day
Last modified on
2017 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006829

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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