UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of acarbose on amelioration of endothelial function evaluated by FMD in type 2 diabetic patients.
Title of the study (Brief title)	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	Eitaro Nakashima
Organization	Chubu Rousai Hospital
Division name	Dept. of Diabetes and Endocrinology
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	Eitaro Nakashima
Organization	Chubu Rousai Hospital
Division name	Dept. of Diabetes and Endocrinology
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000004286