UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Acronym	Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Scientific Title	Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
Scientific Title:Acronym	Clinical study of ileal bile acid transporter inhibitor on changes in bowel movements and various metabolic markers in type 2 diabetic patients
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 evaluate the effects of elobixibat on defecation and various metabolic markers in type 2 diabetic patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bowel movements (frequency of bowel movements, Bristol Scale)
Key secondary outcomes	Blood glucose,HbA1c,LDL,HDL,triglyceride,fatty acid fraction,AST,ALT,gammaGTP,Total bile acid,TSH,FT3,FT4,CRP,UA, Ferritin,body weight

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	10mg elobixibat treatment for 12 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosis of chronic constipation as defined by Rome IV criteria. Type 2 diabetes with HbA1c less than 10%. 20 years of age or older. Patient who can provide written informed consent before enrollment. Patient who had received a stable antidiabetic regimen for at least 3 months prior to study entry. Patient who can obtain blood and urine samples for follow-up before and after the eloboxibat treatment.
Key exclusion criteria	Pregnant or lactating women Patient with intestinal obstruction due to tumor or hernia etc.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Satoko Middle name Last name Yoshinobu
Organization	Kurume University School of Medicine
Division name	Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code	8300011
Address	67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL	0942317563
Email	yoshinobu_satoko@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Satoko Middle name Last name Yoshinobu
Organization	Kurume University School of Medicine
Division name	Department of Internal Medicine, Division of Endocrinology and Metabolism
Zip code	8300011
Address	67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL	0942317563
Homepage URL
Email	yoshinobu_satoko@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University
Institute
Department

Funding Source
Organization	none
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	Industry-Academia-Government Collaboration Office, Kurume University
Address	67 Asahi-machi, Kurume city Fukuoka, JAPAN
Tel	0942317563
Email	sangaku@kurume-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	久留米大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 17 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	21
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	2018 Year 09 Month 09 Day
Date of IRB	2018 Year 10 Month 22 Day
Anticipated trial start date	2018 Year 10 Month 22 Day
Last follow-up date	2020 Year 12 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	2021 Year 09 Month 17 Day
Last modified on	2021 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051959