UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014168 |
|---|---|
| Receipt number | R000016502 |
| Scientific Title | Effect of Sodium-Glucose Cotransporter-2 inhibitor in patients with type 2 daibetes mellitus |
| Date of disclosure of the study information | 2014/06/04 |
| Last modified on | 2016/11/02 16:45:38 |
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Basic information
Public title
Effect of Sodium-Glucose Cotransporter-2 inhibitor in patients with type 2 daibetes mellitus
Acronym
Effect of SGLT2 inhibitor in patients with type 2 daibetes mellitus
Scientific Title
Effect of Sodium-Glucose Cotransporter-2 inhibitor in patients with type 2 daibetes mellitus
Scientific Title:Acronym
Effect of SGLT2 inhibitor in patients with type 2 daibetes 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
The purpose of this study is to assess the effect of therapy of SGLT2 inhibitor on glycemic control and clinical parameters in patients with type 2 diabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The predictive parameters for the effect on SGLT2 inhibitor
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 inhibitors for 12weeks
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
1)type 2 daibetes
2)uncontrollable even after diet and excercise therapy
3)HbA1c:7.0-9.4%
4)treatment with oral hypoglycemic agents or insulin more than 12 weeks
5)age: 20-74 years
6)gender: men and women
Key exclusion criteria
1)severe ketosis, diabetic coma
2)severe infection, before operation, severe trauma
3)allergy for the SGLT2 inhibitor
4)type 1 diabetes
5)chronic renal failure, hemodialysis
6)severe anemia
7)reject to informed consent
8)patients judged by the investigator to be ineligible for some other reason
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenta Okada |
Organization
Jichi Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL
0285-58-7355
kokada@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenta Okada |
Organization
Jichi Medical University
Division name
Endocrinology and Metabolism
Zip code
Address
3311-1 Yakushiji, Shimotsuke-City, Tochigi, Japan
TEL
0285-58-7355
Homepage URL
kokada@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Endocrinology and Metabolism, Jichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nasuchuoh hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
B13-85
Org. issuing International ID_1
Jichi Medical University
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 | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 06 | 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
| 2014 | Year | 06 | Month | 04 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016502
