UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041123