UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014521 |
|---|---|
| Receipt number | R000016186 |
| Scientific Title | Effects of SGLT2 inhibitor (Suglat) on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test. |
| Date of disclosure of the study information | 2014/07/09 |
| Last modified on | 2019/01/14 21:23:16 |
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Basic information
Public title
Effects of SGLT2 inhibitor (Suglat) on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test.
Acronym
The insulin resistance improvement effect of SGLT2 inhibitor (Suglat) in type 2 diabetes mellitus.
Scientific Title
Effects of SGLT2 inhibitor (Suglat) on insulin sensitivity in patients with type 2 diabetes mellitus by the glucose clamp technique and the meal tolerance test.
Scientific Title:Acronym
The insulin resistance improvement effect of SGLT2 inhibitor (Suglat) in type 2 diabetes mellitus.
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 verify the effects of SGLT2 inhibitor (Suglat) on peripheral insulin resistance by the glucose clamp technique and on postprandial glucose metabolism tby the meal tolerance test in Japanese patoents with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of glucose infusion rate during euglycemic-hyperinsulinemic clamp and improvement of HbA1c and postprandial blood glucose.
Key secondary outcomes
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
SGLT2 inhibitor (Suglat) dosage
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
type 2 diabetes mellitus patient.
Key exclusion criteria
Type 1 diabetes mellitus, pancreatic disease, liver disease, renal failure, or those taking diabetogenic medications such as corticosteroids
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youhei Fujioka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address
Nishi-chou 36-1, Yonago, Tottori 683-8504, Japan.
TEL
0859-38-6517
yohei_0201@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youhei Fujioka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine, Endocrinology and Metabolism
Zip code
Address
Nishi-chou 36-1, Yonago, Tottori 683-8504, Japan.
TEL
0859-38-6517
Homepage URL
yohei_0201@ybb.ne.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 07 | Month | 09 | 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 | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 09 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016186
