UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of alfa glucosidase inhibitors (miglitol, voglibose) on efficacy and safety in type 2 diabetic patients with coronary artery disease.
Title of the study (Brief title)	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	Hiroyasu Uzui
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of cardiovascular Medicine
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	Hiroyasu Uzui
Organization	University of Fukui Faculty of Medical Sciences
Division name	Division of cardiovascular Medicine
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

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 04 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006829