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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003868
Receipt No. R000004286
Scientific Title Effect of acarbose on amelioration of endothelial function evaluated by FMD in type 2 diabetic patients.
Date of disclosure of the study information 2011/03/31
Last modified on 2017/01/08

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Basic information
Public title Effect of acarbose on amelioration of endothelial function evaluated by FMD in type 2 diabetic patients.
Acronym Acarbose-FMD clinical trial
Scientific Title Effect of acarbose on amelioration of endothelial function evaluated by FMD in type 2 diabetic patients.
Scientific Title:Acronym Acarbose-FMD clinical trial
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To compare the protective effects of acarbose and voglibose on endothelial function evalutaed by FMD in type 2 diabetes patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Flow Mediated Dilation test
Key secondary outcomes HbA1c, fasting blood glucose/triglyceride and postprandial (2h) blood glucose/triglyceride, LDL-cholesterol, HDL-cholesterol, urinary albumin extraction, body weight, blood pressure

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 acarbose 150-300 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 who have been treated with voglibose 0.9 mg/day for 3 months or more.
2)HbA1c of 6.5%(NGSP) or more.
Key exclusion criteria 1)Patients with ACS within 6 months
2)Patie nts treating with insulin
3)Patients who have undergone a gastrectomy or abdominal surgery
4)Patients with sever hepatic dysfunction or renal dysfunction
5)Patients with serious ketosis, diabetic coma, pre-coma
6)Patients with sever infection, pre-/after recent operation , serious trauma
7)Patients with gastrointestinal disorders such as diarrhea and vomitting
8)Patients with history of sensitivity to acarbose
9)Women who are pregnant or with a possibility of pregnancy
10)Other patients whom the investigator deems unsuitable for inclusion in this study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eitaro Nakashima
Organization Chubu Rousai Hospital
Division name Dept. of Diabetes and Endocrinology
Zip code
Address 1-10-6 Koumei, Minato-ku, Nagoya
TEL +81-52-652-5511
Email eitaro@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eitaro Nakashima
Organization Chubu Rousai Hospital
Division name Dept. of Diabetes and Endocrinology
Zip code
Address 1-10-6 Koumei, MInato--ku, Nagoya
TEL 052-652-5511
Homepage URL
Email eitaro@med.nagoya-u.ac.jp

Sponsor
Institute Chubu Rousai Hospital
Institute
Department

Funding Source
Organization Chubu Rosai Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 中部労災病院(愛知県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 31 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 Completed
Date of protocol fixation
2010 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 07 Month 01 Day
Date of closure to data entry
2011 Year 08 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 05 Day
Last modified on
2017 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004286

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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