UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029064 |
|---|---|
| Receipt number | R000033241 |
| Scientific Title | Effects of SGLT2 inhibitor on insulin resistance possbly through the amelioration of glucose toxicity |
| Date of disclosure of the study information | 2017/09/12 |
| Last modified on | 2022/09/12 16:31:31 |
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Basic information
Public title
Effects of SGLT2 inhibitor on insulin resistance possbly through the amelioration of glucose toxicity
Acronym
SGLT2 inhibitor and insulin resistance
Scientific Title
Effects of SGLT2 inhibitor on insulin resistance possbly through the amelioration of glucose toxicity
Scientific Title:Acronym
SGLT2 inhibitor and insulin resistance
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 change of insulin sensitivity by the administration of SGLT2 inhibitor using glucose clamp method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of glucose infusion rate as an marker of insulin sensitivity by the administration of SGLT2 inhibitor for one week
Key secondary outcomes
The change of insulin secretion, daily profile of blood glucose level, body composition, liver function, lipid profile, uric acid, urine volume and urine sugar by the administration of SGLT2 inhibitor for one week
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
SGLT2 inhibitor, Empagliflrozin 10mg/day, is administered for one week.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes from whom informed consent have been obtained and whose HbA1c level are 8% or over.
Key exclusion criteria
Patients who are treated by insulin, and who have severe acute metabolic disorder.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Tajiri |
Organization
Faculty of Internal Medicine, Kurume University Shcool of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
Asahi-machi 67, Kurume 830-0011, Japan
TEL
0942-31-7563
tajiriy@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Tajiri |
Organization
Faculty of Internal Medicine, Kurume University Shcool of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
Asahi-machi 67, Kurume 830-0011, Japan
TEL
0942-31-7563
Homepage URL
tajiriy@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Endocrinology and Metabolism, Faculty of Internal Medicine, Kurume University Shcool of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Committee, Kurume University
Address
Asahi-machi 67, Kurume 830-0011, Japan
Tel
0942-35-3311
tajiriy@med.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 12 | 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
| 2017 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033241
