UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021623 |
|---|---|
| Receipt number | 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 18:59:00 |
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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
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
ynagai@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024937
