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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036098
Receipt No. 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 2019/09/05

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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
Email 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
Email kumaryo1818@gmail.com

Sponsor
Institute Tsukuba University Hospital Mito Clinical Education and Training Center Mito Kyodo General Hospital
Institute
Department

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
Email 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 Open public recruiting
Date of protocol fixation
2019 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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
2019 Year 03 Month 06 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041123

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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