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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030514
Receipt No. 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 2018/03/03

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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
Email 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
Email takayama@soiken.com

Sponsor
Institute the Japan Society for Patient Reported Outcome (PRO)
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 21 Day
Last follow-up date
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
2018 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034835

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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