UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044317 |
|---|---|
| Receipt number | R000050616 |
| Scientific Title | Efficacy and Safety of SGLT2 inhibitors in patients with type 1 diabete. |
| Date of disclosure of the study information | 2021/05/28 |
| Last modified on | 2021/05/27 14:47:55 |
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Basic information
Public title
Efficacy and Safety of SGLT2 inhibitors in patients with type 1 diabete.
Acronym
SGLT2i in T1DM,Sapporo
Scientific Title
Efficacy and Safety of SGLT2 inhibitors in patients with type 1 diabete.
Scientific Title:Acronym
SGLT2i in T1DM,Sapporo
Region
| Japan |
Condition
Condition
type 1 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SGLT2 inhibitors in patients with type 1 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in HbA1c and weight
Key secondary outcomes
1. Blood and urine test (Plasma glucose, eGFR, UACR, UA, AST, ALT, Hb, etc)
2. Body mass index
3. Blood pressure
4. Insulin dose
5. Diabetic complication
6. Subgroup analysis depends on baseline (age, sex, weight, BMI, kidney function, etc)
7. Adverse events/Discontinuation of medication
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
1) Patients with type 1 diabetes who are treated in Hokkaido University Hospital or collaborate hospitals from December 2018.
2) Patients with type 1 diabetes who have been treated with SGLT2 inhibitors.
Key exclusion criteria
Patients who were thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Division of Diabetes and Obesity
Division name
Division of Diabetes and Obesity
Zip code
0608638
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-716-1161
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Division of Diabetes and Obesity
Zip code
0608638
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-8192
Homepage URL
hmiyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Hokkaido University Hospital , Clinical Research Management Department
Address
Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan
Tel
0117067636
crjimu@med.hokudai.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
小野百合内科クリニック（北海道）、栗原内科クリニック(北海道)、青木内科クリニック(北海道)、萬田記念病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study using medical record information
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050616
