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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042407
Receipt No. R000048408
Scientific Title Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus
Date of disclosure of the study information 2020/11/10
Last modified on 2020/11/10

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Basic information
Public title Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus
Acronym Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus
Scientific Title Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for type 1 diabetes mellitus
Scientific Title:Acronym Assessing patient body composition following treatment with sodium glucose co-transporter 2 inhibitor for 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 To clarify the change of body composition in using SGLT2 inhibitors in patients with type 1 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of body composition measured by impedance method 52 weeks after ipragliflozin administration.
Key secondary outcomes To assess safety and efficacy, the data prior to and three months subsequent of the oral administration of the SGLT2 inhibitor were collected such as body mass index, glycated hemoglobin (HbA1c), and glycemic variability were obtained from flash glucose monitoring (FGM) systems (Free Style Libre; Abbott Diabetes Care, Witney, UK) measured for three months prior to and three months subsequent of the oral administration of the SGLT2 inhibitor. Retrospective data included the insulin dose, the number of severe hypoglycemia incidence requiring assistance, diabetic ketoacidosis, and other side effects.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50mg of ipragliflozin
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Type 1 diabetes mellitus obtained consent to participate in research
Patients with glycated hemoglobin (HbA1c) of 6.5% or higher and less than 10%
Patients with body mass index (BMI) of 18.5 kg/m2 or higher
Key exclusion criteria Patients who do not agree to participate in the study
Patients judged by the attending physician that there is no indication for SGLT2 inhibitor administration
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Ryoichi
Middle name
Last name Ishibashi
Organization Kimitsu Chuo Hospital
Division name Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code 292-8535
Address 1010 Sakurai, Kisarazu-city, Chiba
TEL +81-438-36-1071
Email ishibashi-cib@umin.net

Public contact
Name of contact person
1st name Ryoichi
Middle name
Last name Ishibashi
Organization Kimitsu Chuo Hospital
Division name Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code 292-8535
Address 1010 Sakurai, Kisarazu-city, Chiba
TEL +81-438-36-1071
Homepage URL
Email ishibashi-cib@umin.net

Sponsor
Institute Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Kimitsu Chuo Hospita
Institute
Department

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 Kimitsu Chuo Hospital
Address 1010 Sakurai, Kisarazu-city, Chiba
Tel +81-438-36-1071
Email soumu@kc-hosp.or.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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 26 Day
Date of IRB
2019 Year 03 Month 26 Day
Anticipated trial start date
2019 Year 03 Month 26 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 10 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048408

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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