UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017461 |
|---|---|
| Receipt number | R000020237 |
| Scientific Title | Effects of a SGLT2 Inhibitor in type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/18 11:12:13 |
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Basic information
Public title
Effects of a SGLT2 Inhibitor in type 2 Diabetes Mellitus
Acronym
Effects of a SGLT2 Inhibitor in type 2 DM
Scientific Title
Effects of a SGLT2 Inhibitor in type 2 Diabetes Mellitus
Scientific Title:Acronym
Effects of a SGLT2 Inhibitor in type 2 DM
Region
| Japan |
Condition
Condition
type 2 Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore effects of a SGLT2 Inhibitor in type 2 Diabetes Mellitus
Basic objectives2
Others
Basic objectives -Others
evaluation on a control of blood glucose and the other effects
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
blood glucose
body weight
Key secondary outcomes
renal function
uremic toxin
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients are determined to be treated with a SGLT2 Inhibitor
Key exclusion criteria
The patient:
*has a history of allergy to this drug
*has moderate or severer kidney disease with uncontorolled electrolyte imbalance, volume overload, and/or advanced malnutrition
*is on renal replacement therapy
*has developed type1 DM
*has diabetic ketoacidosis or diabetic -/pre comatose
*is with severe infectious disease, in perioperative period, or with severe trauma
*is under the twenty years of age
*is unable to give a written informed concent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takefumi Mori |
Organization
Tohoku University Hospital
Division name
Nephrology, endocrinology and vascular medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai City, Miyagi 980-8574, Japan
TEL
022-717-7163
tmori@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Koizumi |
Organization
Tohoku University Hospital
Division name
Nephrology, endocrinology and vascular medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai City, Miyagi 980-8574, Japan
TEL
022-717-7163
Homepage URL
kenjikoism@med.tohoku.ac.jp
Sponsor or person
Institute
Nephrology, endocrinology and vascular medicine at Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Donation
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 05 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prior to registration for this study, a medical doctor in charge is is supposed to explain to the patient about and make sure that the patient agrees to participate in the study of his/her own free will. The medical doctor in charge should also ensure that the patients gives his or her informed consent.
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020237
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
