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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021623
Receipt No. R000024937
Scientific Title Effects of ipragliflozin on body composition and beta-cell function in Japanese patients with type 2 diabetes
Date of disclosure of the study information 2016/03/27
Last modified on 2016/04/19

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Basic information
Public title Effects of ipragliflozin on body composition and beta-cell function in Japanese patients with type 2 diabetes
Acronym Effects of ipragliflozin on body composition and beta-cell function
Scientific Title Effects of ipragliflozin on body composition and beta-cell function in Japanese patients with type 2 diabetes
Scientific Title:Acronym Effects of ipragliflozin on body composition and beta-cell function
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to clarify the effect of an SGLT2 inhibitor (ipraglifrozin) on body composition and beta-cell function.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes %Change of visceral fat volume assessed by CT and %change of intrahepatic lipid content assessed by 1H-MRS at 0-, 12- and 24-week of ipraglifrozin treatment
Key secondary outcomes beta-cell stress assessed by the change of plasma intact proinsulin / C-peptide (PI/CPR) ratio at 0-, 12- and 24-week of ipraglifrozin treatment

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 ipraglifrozin 50mg/day for 24 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
80 years-old >=
Gender Male and Female
Key inclusion criteria Outpatients
HbA1c >= 6.5%
20 <= BMI <= 40
Key exclusion criteria The exclusion criteria were pregnancy, severe illness, CKD (eGFR < 60 ml/min/1.73m2), and malignancy.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Tanaka
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email smu.tainai@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Nagai
Organization St. Marianna University School of Medicine
Division name Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email ynagai@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 27 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
2014 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 26 Day
Last modified on
2016 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024937

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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