UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029064
Receipt No. 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 2019/03/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tajiriy@med.kurume-u.ac.jp

Sponsor
Institute Division of Endocrinology and Metabolism, Faculty of Internal Medicine, Kurume University Shcool of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 19 Day
Date of IRB
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
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033241

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.