UMIN-CTR Clinical Trial

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

type 2 diabetes patients with coronary artery disease

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Coronary Flow Reserve

Key secondary outcomes

blood glucose, inflammatory marker, Cardiac function

Study type

Interventional

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

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

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

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

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

Institute

University of Fukui Faculty of Medical Sciences

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福井大学医学部

Date of disclosure of the study information

2011

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

06

Month

14

Day

Last modified on

2017

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006829