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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019192
Receipt No. 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 2017/04/03

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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
Middle name
Last name Noriyuki Sonoda
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Bioregulatory
Zip code
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
Middle name
Last name Noriyuki Sonoda
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Bioregulatory
Zip code
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
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 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
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 No longer recruiting
Date of protocol fixation
2015 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 08 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
2015 Year 10 Month 01 Day
Last modified on
2017 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.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


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