UMIN-CTR Clinical Trial

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
Email	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/
Email	jbr@a2healthcare.com

Sponsor
Institute	J-BRAND Registry Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009109