UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021262 |
|---|---|
| Receipt number | R000024474 |
| Scientific Title | A Multicenter Parallel-group Study for Effect of Dapagliflozin on Dietary Behavior of Patients with Type 2 Diabetes |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/09/18 10:30:23 |
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Basic information
Public title
A Multicenter Parallel-group Study for Effect of Dapagliflozin on Dietary Behavior of Patients with Type 2 Diabetes
Acronym
A Multicenter Parallel-group Study for Effect of Dapagliflozin on Dietary Behavior of Patients with Type 2 Diabetes
Scientific Title
A Multicenter Parallel-group Study for Effect of Dapagliflozin on Dietary Behavior of Patients with Type 2 Diabetes
Scientific Title:Acronym
A Multicenter Parallel-group Study for Effect of Dapagliflozin on Dietary Behavior of Patients with Type 2 Diabetes
Region
| Japan |
Condition
Condition
Adults with type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is planned to elucidate whether eating behavior is changed by dapagliflozin or not by using BDHQ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Inter-group comparison of the change of total calorie intake during 12 weeks
Key secondary outcomes
Secondary endpoint
Intergroup comparison of the change of following items before and after the therapy
1) A nutritional status based on BDHQ
2)Body weight, blood pressure, abdominal circumference, grip strength
3) Blood sugar profile (HbA1c, PG)
4) Lipid profile (TC, HDL-C, TG)
Exploratory endpoint
Intergroup comparison of the change of following items before and after the therapy
1) Body composition
2) Basal metabolism
3) Amount of physical activity
4) Glucagon
Relationship with BDHQ variation
Variations of body weight and abdominal circumference, and variation of BDHQ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In addition to current diet therapy and exercise therapy, dapagliflozin 5 mg is administered once a day for 12 weeks.
Interventions/Control_2
Current diet therapy, exercise therapy and diabetes therapeutic drug are continued for 12 weeks.
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
1) Type 2 diabetic patients whose HbA1c is in a constant range from 6.5% to 8.5%
2) Patients whose age is over 20 years but under 75 years old
3) Patients from whom consent for participating in this study was obtained in writing
Key exclusion criteria
1) Type 1 diabetic patients
2) Patients who were administered SGLT2 inhibitor within 8 weeks before starting the treatment.
(prior treatment with SGLT2 should have not been stopped due to intolerable side effects).
3) Patients whose eGFR is <45ml/min/1.73 m2
4) Patients with history of severe liver problems as shown below
Patients whose AST and/or ALT exceeds 3-fold of upper limit of facility standard value
Patients whose total bilirubin exceeds 2.0 mg/dL (34.2 µmol/L)
5) Patients who have medical history of hypersensitivity to the ingredients of SGLT2 inhibitor
6) Patients with severe ketosis, diabetic coma or precoma
7) Patients with severe infectious disease and serious trauma, and perioperative patients
8) Patients suffering from shock, cardiac insufficiency, myocardial infarction, cardiovascular system problems including pulmonary embolism, and severe insufficiency in pulmonary function, and patients whose conditions easily develop other hypoxemia
9) Patients who are in the status of bad nutrition, starvation, irregular meal intake, lack of the dietary intake, and hyposthenia
10) Patients with pituitary gland dysfunction or adrenal gland dysfunction
11) Patients who drink alcohol excessively including alcohol abuse
12) Patients with dehydration, gastrointestinal disorder including diarrhoea, vomiting due to which dehydration state is concerned
13) Patients with malignancies
14) Pregnant patients, patients who may be pregnant, and patients with breast-feeding
15) Patients who are judged inadequate in participating in this study by their doctors in charge
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Kitaoka |
Organization
Non-Profit Organization West Tokyo Diabetes Association
Division name
Board member
Zip code
Address
2-23-5-802 Honcho, Kokubunji-shi, Tokyo, 1850012 Japan
TEL
042-322-7468
masafumi.kitaoka@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohide Noumi |
Organization
IBEC Co., Ltd.
Division name
CEO Office
Zip code
Address
Tanaka Jun Build. 3F, 2-5-14 Teradacho, Tennohji-ku, Osaka-shi, 5430045, Japan
TEL
06-7172-1751
Homepage URL
reseach@ibec-jp.com
Sponsor or person
Institute
Non-Profit Organization West Tokyo Diabetes Association
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K.
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Metabolic Signal Research Center, Institute for Molecular and Cellular Regulation, Gunma University
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
医療法人社団桜一会かんの内科（東京都）
医療法人社団明芳会イムス三芳総合病院（埼玉県）
公立昭和病院（東京都）
日本医科大学多摩永山病院（東京都）.
医療法人社団ユスタヴィア多摩センタークリニックみらい（東京都）
東京医科大学八王子医療センター（東京都）
医療法人社団ユスタヴィアクリニックみらい国立（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 05 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024474
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| Registered date | File name |
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| Registered date | File name |
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