UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007976 |
|---|---|
| Receipt number | R000009109 |
| Scientific Title | Japan-Based clinical ReseArch Network for Diabetes Registry |
| Date of disclosure of the study information | 2012/05/21 |
| Last modified on | 2021/03/30 15:04:20 |
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Basic information
Public title
Japan-Based clinical ReseArch Network for Diabetes Registry
Acronym
J-BRAND Registry
Scientific Title
Japan-Based clinical ReseArch Network for Diabetes Registry
Scientific Title:Acronym
J-BRAND Registry
Region
| Japan |
Condition
Condition
Diabetes type 2
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to construct a database regarding the long-term (3years) clinical course in type 2 diabetes patients who receive OHAs in daily clinical practice and evaluate the safety and efficacy of alogliptin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence, type, and severity of adverse events will be compared between patients treated with alogliptin and patients not treated with any dipeptidyl peptidase-4 (DPP-4) inhibitor at the time of registration (between-group comparison) and among subgroups defined by patient baseline characteristics and by concomitant medications (between- subgroup comparison). All adverse events will be included in the safety evaluation, and major safety endpoints will include hypoglycemia, pancreatitis, skin disorder, infections, and cancer.
Key secondary outcomes
Efficacy variables will be compared between patients treated with alogliptin and patients not treated with any DPP-4 inhibitor at the time of registration (between-group comparison) and among subgroups defined by patient baseline characteristics and by concomitant medications (between-subgroup comparison). The efficacy variables will include the changes from baseline (= time of registration) in the levels of hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin, and urinary albumin and the new onset and progression of microangiopathy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subject eligibility will be determined according to the following criteria:
(1)Patients who have received a diagnosis of type 2 diabetes and are treated with at least one OHA as per the package insert for the OHA.
(2)Patients who have started or added an OHA, or switched* from one OHA to another within the previous 3 months and meet one of the following criteria:
Group A: Subjects treated with alogliptin at the time of registration
(Alogliptin-treated group)
i)Start: Patients who have started alogliptin
ii)Add:Patients who have added alogliptin to OHA(s) (excl. DPP-4 inhibitors) currently taken
iii)Switch:Patients who have switched a part or all of OHAs currently taken to alogliptin
Group B: Subjects not treated with any DPP-4 inhibitor at the time of registration
(DPP-4 inhibitor-untreated group)
i)Start: Patients who have started an OHA other than DPP-4 inhibitors
ii)Add: Patients who have added another OHA, other than DPP-4 inhibitors, to OHA(s) (excl. DPP-4 inhibitors) currently taken
iii)Switch:Patients who have switched a part or all of OHAs currently taken to another OHA, other than DPP-4 inhibitors, and are not treated with any DPP-4 inhibitor at the time of registration
*:This applies to active pharmaceutical ingredients only. A switch from one OHA (including combination drug products) to another of the same active pharmaceutical ingredient will not be included in the Switch category.
(3)Gender and Age: men and women of at least 20 years of age at the time of informed consent
(4)Patients willing and able to provide written informed consent prior to participation in this study
Key exclusion criteria
Any subject who meets any of the following criteria will not qualify for entry into the study:
(1)Patients using parenteral hypoglycemic agents (insulin and glucagon-like peptide-1 [GLP-1] receptor agonists)
(2)Patients with severe ketosis, diabetic coma or precoma, severe infection, or serious trauma and patients under the perioperative management
(3)Pregnant or lactating women
(4)Patients judged by the principal investigator or sub-investigator to be ineligible for participation as study subjects for any other reason
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kadowaki |
Organization
J-BRAND Registry Study Group
Division name
Graduate School of Medicine The University of Tokyo/Graduate School of Medicine The University of Teikyo
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo, Tokyo, 113-8655 Japan
TEL
03-3830-1075
jbr@a2healthcare.com
Public contact
Name of contact person
| 1st name | Daisaku |
| Middle name | |
| Last name | Iwata |
Organization
J-BRAND Registry Administrative Office
Division name
A2 Healthcare Corporation
Zip code
112-0002
Address
1-4-1, Koishikawa, Bunkyo-ku, Tokyo 112-0002, JAPAN
TEL
03-3830-1075
Homepage URL
http://www.j-brand-registry.com/
jbr@a2healthcare.com
Sponsor or person
Institute
J-BRAND Registry Study Group
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401,mita,minato-ku,tokyo,Japan
Tel
03-3830-1075
jbr@a2healthcare.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
| 2012 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/bmjopen/4/9/e004760.full.pdf
Publication of results
Published
Result
URL related to results and publications
https://drc.bmj.com/content/bmjdrc/9/1/e001787.full.pdf
Number of participants that the trial has enrolled
5208
Results
The same level of safety and efficacy was shown between groups A and B, confirming the usefulness of alogliptin for the treatment of type 2 diabetes
Results date posted
| 2019 | Year | 05 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Posting request
Date of the first journal publication of results
| 2021 | Year | 01 | Month | 13 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 16 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
This is a large-scale, multicenter, prospective, observational study in which 20,000 type 2 diabetes patients who have started or added an OHA, or switched from one OHA to another will be consecutively registered by the central registration method and followed for 3 years.
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009109
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
