UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036098 |
|---|---|
| Receipt number | R000041123 |
| Scientific Title | The effect of lowering blood glucose regarding SGLT2 inhibitor in type 1 diabetes mellitus |
| Date of disclosure of the study information | 2019/03/06 |
| Last modified on | 2020/09/05 11:37:56 |
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Basic information
Public title
The effect of lowering blood glucose regarding SGLT2 inhibitor in type 1 diabetes mellitus
Acronym
The effect of SGLT2 inhibitor in type 1 diabetes mellitus
Scientific Title
The effect of lowering blood glucose regarding SGLT2 inhibitor in type 1 diabetes mellitus
Scientific Title:Acronym
The effect of SGLT2 inhibitor in type 1 diabetes mellitus
Region
| Japan |
Condition
Condition
Type 1 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of improving blood glucose and glucose variability between SGLT2 inhibitor and alpha
glucosidase inhibitor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, Total daily dose of insulin, BMI
Key secondary outcomes
average blood glucose, standard deviation, mean amplitude of glycemic excursion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administrating Ipragliflozin 50 mg/day on basal-bolus insulin for 12 weeks
Interventions/Control_2
Administrating Voglibose 0.9 mg/day on basal-bolus insulin for 12 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 1 diabetic patients who treat only basal-bolus therapy
Key exclusion criteria
1.Patients who treat with CSII.
2.Patients who have history of diabetic coma, severe diabetic ketosis or hyperglycemic hyperosmolar symdrome.
3.1. Patients with severe infection, severe injury or perioperative state.
4.1. Patients with severe diabetic complications such as neuropathy, retinopathy and nephropathy.
5.BMI of patients under 17.5 kg/m2.
6.eGFR of patients less than 45 mL/min/1.73m2.
7.Patients with history of ileus.
8.Patients with vulvitis.
9.Pregnant
10.Patients whom researchers rule out as inappropriate subjects.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki Yagyu |
| Middle name | |
| Last name | Hiroaki Yagyu |
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name
Endocrinology and Metabolism
Zip code
310-0015
Address
3-2-7 Miya-machi, Mito, Ibaraki, Japan 310-0015
TEL
029-231-2371
hiroakiyagyu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ryo Kumagai |
| Middle name | |
| Last name | Ryo Kumagai |
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Division name
Endocrinology and Metabolism
Zip code
310-0015
Address
3-2-7 Miya-machi, Mito, Ibaraki, Japan 310-0015
TEL
029-231-2371
Homepage URL
kumaryo1818@gmail.com
Sponsor or person
Institute
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
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
Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Address
3-2-7 Miya-machi, Mito, Ibaraki, Japan 310-0015
Tel
029-231-2371
kumaryo1818@gmail.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 | 03 | Month | 06 | 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
Suspended
Date of protocol fixation
| 2019 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2020 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041123
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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