UMIN-CTR Clinical Trial

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
Email	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
Email	yurino@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Medicine and Bioregulatory, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021828