UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030514 |
|---|---|
| Receipt number | R000034835 |
| Scientific Title | The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL (J-BOND study) |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2022/06/27 09:21:15 |
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Basic information
Public title
The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL (J-BOND study)
Acronym
The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL (J-BOND study)
Scientific Title
The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL (J-BOND study)
Scientific Title:Acronym
The Japanese T2D study for evaluating Benefits Of a New first-line therapy with Dapagliflozin in consideration of improving QOL (J-BOND study)
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore efficacy of dapagliflozin as a first-line medication for treating T2DM patients from the perspective of patients' quality of life (QOL)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with "improved" in "Overall quality of life" domain of SHIELD-WQ-9 at the 24th week
Key secondary outcomes
The following evaluation items from baseline to the 24th week
1. Proportion of patients with "improved" in each domain of SHIELD-WQ-9 (except for the primary endpoint)
2. Changes in the DTR-QOL domain scores
3. Change in EQ-5D-5L
4. Medication preference
5. Relationships between medication preference and each questionnaire
6. HbA1c
7. Body weight, BMI, abdominal circumstance
8. lipid metabolism marker (TC, HDL-C, TG, LDL-C)
9. Renal function marker (eGFR, urinary albumin)
10. Correlation between QOL scores and blood test results as well as urine test results
11. Occurrence of adverse event (ratio of hypoglycemia, etc.)
12. Medication adherence rates
13. Adherence rates to dietary therapy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: Administer dapagliflozin
Interventions/Control_2
Group B: Administer DPP-4 inhibitor
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included in this study:
1. T2DM patients who are newly started treatment with an OHA
2. Patients with HbA1c 6.5% or higher at consenting
3. Patients with BMI 23 kg/m2 or greater
4. Male and female patients aged 20 years or older and younger than 75 years when giving their consent
5. Patients who can give their consent in a written form
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from participating in the study:
1. Patients with any experience of using any antidiabetic medication within last three months
2. Patients with medical history of severe hypoglycemia within a year
3. Patients with type 1 diabetes mellitus or secondary diabetes
4. Patients during a perioperative period, or patients with severe infection or severe physical injury
5. Patients with moderate to severe heart failure (NYHA/New York Heart Association at class III or higher)
6. Patients with moderate renal disease (eGFR < 45mL/min/1.73 m2)
7. Patients with severe liver disease (AST 100 IU/l or higher)
8. Patients who are addicted to alcohol or a drug
9. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
10. Patients with dementia
11. Patients with a contraindicated condition to use the study drug
12. Patients with other conditions that the investigator/researcher thinks inappropriate for the study
Target sample size
252
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Professor Hitoshi Ishii |
Organization
Nara Medical University
Division name
Department of Diabetology
Zip code
Address
840 Shijo-cho,Kashihara, Nara, Japan
TEL
0744-22-3051
info@japanpro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Clinical Study Support Division
Zip code
Address
NBF Ogawamachi Building 4F, 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
the Japan Society for Patient Reported Outcome (PRO)
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034835
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