UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Title of the study (Brief title)	Comparison of effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of a DPP-4 inhibitor and an alpha-glucosidase inhibitor on visceral fat and oxidative stress in type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat mass and oxidative stress
Key secondary outcomes	1) HbA1c 2) high sensitive CRP 3) urinary protein/creatinine ratio, urinary albumin/creatinine ratio, eGFR 4) renin angiotensin system: plasma renin activity, plasma aldosterone concentration, plasma prorenin concentration, plasma soluble (pro) renin receptor, urinary prorenin excretion, urinary (pro)renin excretion 5) body weight, waist circumference, adiponectin 6) endothelial function: flow mediated dilation and nitroglycerin mediated dilation 7) atherosclerosis: CAVI and AI

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	treatment with sitagliptin
Interventions/Control_2	treatment with acarbose
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	- patients with diabetes mellitus - HbA1c (JDS) of 6.1 to 8.0% - under treatment with 1) diet therapy and exercise, 2) sulphonylurea, 3) metformin, or 4) suophnylurea and metformin
Key exclusion criteria	allergy to sitagliptin or acarbose
Target sample size	100

Research contact person
Name of lead principal investigator	Atsuhiro Ichihara
Organization	Tokyo Women's Medical University
Division name	Department of Medicine II, Endocrinology and Hypertension
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Email	smorimoto@endm.twmu.ac.jp

Public contact
Name of contact person	Satoshi Morimoto
Organization	Tokyo Women's Medical University
Division name	Department of Medicine II, Endocrinology and Hypertension
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	smorimoto@endm.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京女子医科大学、東京都 Tokyo Women's Medical University, Tokyo

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 03 Month 22 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 25 Day
Last modified on	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008208