UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051180 |
|---|---|
| Receipt number | R000058373 |
| Scientific Title | The change in FIB-4 in Japanese patients with type 2 diabetes treated by a fixed-ratio combination therapy of insulin degludec and liraglutide (IDegLira) |
| Date of disclosure of the study information | 2023/05/28 |
| Last modified on | 2023/05/28 10:17:26 |
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Basic information
Public title
The change in FIB-4 in Japanese patients with type 2 diabetes treated by a fixed-ratio combination therapy of insulin degludec and liraglutide (IDegLira)
Acronym
The change in FIB-4 in Japanese patients with type 2 diabetes treated by a fixed-ratio combination therapy of insulin degludec and liraglutide (IDegLira)
Scientific Title
The change in FIB-4 in Japanese patients with type 2 diabetes treated by a fixed-ratio combination therapy of insulin degludec and liraglutide (IDegLira)
Scientific Title:Acronym
The change in FIB-4 in Japanese patients with type 2 diabetes treated by a fixed-ratio combination therapy of insulin degludec and liraglutide (IDegLira)
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of FRC therapy using a combination preparation of insulin degludec and liraglutide (IDegLira) in Japanese patients with type 2 diabetes comparing the presence or absence of GLP-1RAs before the start of FRC therapy, focusing particularly on the change in FIB-4, a noninvasive evaluation method for liver fibrosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in FIB-4 during 6 months of observation after the initiation of IDegLira
Key secondary outcomes
The changes in the HbA1c value and body weight and the adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were continued IDegLira therapy for more than 6 months
Key exclusion criteria
IDegLira was started at dose >16 dose steps
IDegLira had already been administered at the initial consultation
Antidiabetic agents other than IDegLira were changed during observation period
Patients who discontinued treatment during observation period
Patients who were transport to other hospitals during observation period
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
TEL
03-3673-1221
ito@edogawa.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ito |
Organization
Edogawa Hospital
Division name
Department of Diabetes, Metabolism and Kidney Disease
Zip code
133-0052
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
TEL
03-3673-1221
Homepage URL
ito@edogawa.or.jp
Sponsor or person
Institute
Edogawa Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Edogawa Hospital
Address
2-24-18, Higashikoiwa, Edogawa-Ku, Tokyo
Tel
03-3673-1221
ito@edogawa.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
| 2023 | Year | 05 | Month | 28 | 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
137
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 05 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058373
