UMIN-CTR Clinical Trial

Basic information
Public title	The study on efficacy of Rituximab in new onset Type 1 diabetes mellitus
Acronym	Efficacy of RTX in new onset Type 1 DM
Scientific Title	The study on efficacy of Rituximab in new onset Type 1 diabetes mellitus
Scientific Title:Acronym	Efficacy of RTX in new onset Type 1 DM
Region	Japan

Condition
Condition	Type 1 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The examination on efficacy of Rituximab in new onset Type 1 diabetes mellitus about pancreatic cytoprotection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of change of curve undersurface area of the serum C peptide concentration in the meal load examination 12 months after rituximab administration.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Rituximab
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients diagnosed Type 1 diabetes mellitus within 3 months after onset, and whose capacity for endogenous insulin secretion was retained.
Key exclusion criteria	Patients using insulin therapy, those who were or may have been pregnant, and those with severe liver dysfunction (AST and ALT: 3 times the normal levels) were excluded.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yoshiya Middle name Last name Tanaka
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-603-1611
Email	tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Kurozumi
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
Zip code	807-8555
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
TEL	093-603-1611
Homepage URL
Email	akira@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Institute
Department

Funding Source
Organization	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	University of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine
Address	1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu
Tel	093-603-1611
Email	akira@med.uoeh-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 03 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	Open public recruiting
Date of protocol fixation	2011 Year 03 Month 31 Day
Date of IRB	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 03 Day
Last modified on	2020 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015316