UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019192 |
|---|---|
| Receipt number | R000021828 |
| Scientific Title | Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2021/05/31 08:13:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes Mellitus
Acronym
Dapagliflozin Intervention Trial (DIET)
Scientific Title
Investigation of the Effect of Dapagliflozin on Body Composition and Diet in Japanese Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym
Dapagliflozin Intervention Trial (DIET)
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 examine the hypoglycemic action of dapagliflozin and its effects on body composition and dietary intake during weight loss in Japanese patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of body composition (fat content) measured by a body composition analyzer (InBody770K) over the 104-week treatment period.
Key secondary outcomes
1) Body composition parameters (muscle mass and fat/non-fat ratio).
2) Investigation of dietary behavior and food intake using a questionnaire (BDHQ and DEBQ).
3) Indexes of glycemic control and pancreatic beta-cell function.
4) Indexes of diabetic nephropathy/renal function.
5) Indexes of lipid metabolism.
6) Effects on the bone (bone density, bone formation, and bone metabolism markers)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The study period has a duration of 104 weeks from the time of enrollment. The investigator will initiate treatment with dapagliflozin and will aim to achieve the target levels in the Treatment Guide for Diabetes 2014-2015 (HbA1c <7.0%, fasting blood glucose <130 mg/dL, and 2-hour postprandial blood glucose <180 mg/dL). In adults, orally administer Forxiga 5 mg (5 mg as dapagliflozin) once daily. If the effect is insufficient, the dose may be increased to 10 mg once daily while carefully observing the patient.
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 20-74 years at the time of giving informed consent.
2) Provides written informed consent to participation in the study.
3) HbA1c is 7.0% or higher.
4) BMI is 22 kg/m2 or more.
Key exclusion criteria
1) Patients with type 1 diabetes mellitus or secondary diabetes.
2) Patients with infection, postoperative/preoperative status, or severe trauma.
3) Patients with a history of myocardial infarction, angina pectoris, stroke, cerebral infarction, or transient ischemic attacks (TIA).
4) Patients with diabetic retinopathy requiring photocoagulation or vitreous surgery or those who have undergone any of these operations within one year.
5) Patients with moderate or worse renal dysfunction (eGFR < 45mL/min/1.73m2).
6) Patients with severe hepatic dysfunction (Child-Pugh Class C) or liver cirrhosis.
7) Patients with moderate or severe cardiac failure (New York Heart Association Class III or IV).
8) Patients taking GLP-1 receptor agonists.
9) Pregnant or breast-feeding women, as well as women of childbearing potential or those who plan to become pregnant.
10) Patients with a history of hypersensitivity to the study drug.
11) Patients with severe ketosis, diabetic coma, or precoma.
12) Patients with pacemaker.
13) Other patients who are deemed to be inappropriate for the study by the attending physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Sonoda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5284
yurino@intmed3.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Sonoda |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Bioregulatory
Zip code
8128582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
TEL
092-642-5284
Homepage URL
yurino@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
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
Other related organizations
Co-sponsor
Takagi hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Medical District Department Ethics Review Committee
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka City, 812-8582 Japan
Tel
092-642-5774
byssien@jimu.kyushu-u.ac.jp
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
九州大学病院（福岡県）、高木病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
http://jscm70.umin.jp/program.html
Publication of results
Published
Result
URL related to results and publications
http://jscm70.umin.jp/program.html
Number of participants that the trial has enrolled
60
Results
As a result of treatment with dapagliflozin to 54 Japanese patients with type 2 diabetes for 2 years, body weight was significantly reduced, in addition to the improvement of blood glucose and blood pressure.
This study suggested that most of the weight loss was due to the decreases in body fat mass and fatty liver.
Results date posted
| 2021 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1) Japanese patients with type 2 diabetes
2) 20 to 74 years old
3) HbA1c 7.0% or more
4) BMI 22kg / m2 or more
Participant flow
1) Of the 60 registered cases, 4 were apnea-free due to voluntary discontinuation, and 56 were subject to SAS. In addition, 2 cases were rejected from FAS due to the mismatch from the research plan, and 54 cases were subject to FAS.
2) The number of untreated cases, the number of treated cases, the number of discontinued cases, and the number of completed cases were tabulated for the registered cases. For the cases of discontinuation, the breakdown of the reasons was tabulated. Cases completed up to 24 months (104 weeks) were considered as completed cases.
Adverse events
The number of cases with adverse events was 4 (5.4%): they included bacterial pneumonia, splenic infarction, atrial fibrillation, and bipolar type 1 disorder. However, these adverse events have not proven the clear causal relationship with dapagliflozin administration.
Outcome measures
Primary endpoint
Changes in body composition (fat mass) measured with a high-precision body composition analyzer (InBody770K) during the 104-week treatment period
Secondary evaluation items
1) Body composition (muscle mass, fat / non-fat mass)
2) Eating behavior / meal content survey using questionnaires by using BDHQ and DEBQ
3) Various indicators related to glycemic control and pancreatic beta-cell function
4) Various indicators related to diabetic nephropathy and renal function
5) Various indicators related to osteoporosis
6) Various indicators related to fatty liver
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
