UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037872 |
|---|---|
| Receipt number | R000043176 |
| Scientific Title | Long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with type 2 diabetes mellitus. |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2020/02/29 10:34:29 |
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Basic information
Public title
Long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with type 2 diabetes mellitus.
Acronym
Long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with type 2 diabetes mellitus.
Scientific Title
Long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with type 2 diabetes mellitus.
Scientific Title:Acronym
Long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with 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
We retrospectively evaluated the long-term efficacy and safety of the SGLT2 inhibitors in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the change in the eGFR slope and urine albumin creatinine ratio
Key secondary outcomes
Metabolic marker; HbA1c and body weight
Hemodynamic marker; systolic and diastolic blood pressure, and heart rate
Liver enzyme marker; AST, ALT and gamma-GTP
Liver fibrosis marker; Fib-4 index
Arteriosclerosis marker; IMT, PWV and ABI
Others; Uric acid and hemoglobin
Safety marker; incidence rate of Hypoglycemia, serum albumin level
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes
Administration of SGLT2 inhibitors
Key exclusion criteria
Participation in the study is judged by the investigator or sub-investigator as inappropriate for any other reason
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Osonoi |
Organization
Nakakinen Clinic
Division name
Director
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Ofuchi |
Organization
Nakakinen Clinic
Division name
Department of clinical research
Zip code
311-0113
Address
745-5 Nakadai, Naka-shi, Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen Clinic
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Nakakinen Clinic
Address
745-5 Nakadai, Naka-shi, Ibaraki
Tel
029-353-2800
k-ofuchi@kensei-kai.com
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
| 2019 | Year | 08 | Month | 31 | 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
630
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
| 2019 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Single facility retrospective observation study
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2020 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043176
