UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042407 |
|---|---|
| Receipt number | 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 | 2024/05/09 14:40:19 |
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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
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
ishibashi-cib@umin.net
Sponsor or person
Institute
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism, Kimitsu Chuo Hospita
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
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-city, Chiba
Tel
+81-438-36-1071
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
https://link.springer.com/article/10.1007/s13300-021-01047-5
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s13300-021-01047-5
Number of participants that the trial has enrolled
20
Results
After 52 weeks of treatment, the total fat mass tended to be reduced. In addition, skeletal muscle mass also decreased. Although the basal insulin dose was reduced, SGLT2 inhibitors decreased HbA1c levels. FGM revealed that glycemic variabilities were also reduced, and time within the target glucose range increased.
Results date posted
| 2024 | Year | 05 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to Table 1 of the published paper for patient background.
Participant flow
A total of 28 patients were assessed for eligibility and 24 patients were enrolled. Efficacy analyses were performed on the 20 patients administrated ipragliflozin for 52 weeks
Adverse events
We recorded one case of severe hypoglycemia and one case of diabetic ketoacidosis during the study period. Diabetic ketoacidosis was caused by an obstruction of the insulin pump and recovered by insulin injection.
Outcome measures
The primary outcome was any change in the body composition measured by bioelectrical impedance analysis (BIA) using InBody S10 (Inbody Co, Ltd., Seoul, Korea) 52 weeks after ipragliflozin administration.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 10 | Day |
Last modified on
| 2024 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048408
