UMIN-CTR Clinical Trial

Basic information
Public title	Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes
Acronym	Effect of SGLT2 inhibitor combined with metformin on body composition
Scientific Title	Effect of SGLT2 inhibitor, Dapagliflozin combined with or without metformin on body composition in patients with type 2 diabetes
Scientific Title:Acronym	Effect of SGLT2 inhibitor combined with metformin on body composition
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 changes of body composition and muscle strength between Dapagliflozin combined with or without metformin in patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the changes in total body muscle mass evaluated by dual-energy x-ray absorptiometry (DXA) before and after 24 weeks between the two groups
Key secondary outcomes	Comparison of the changes in quadriceps muscle strength measured by a hand-held dynamometer before and after 24 weeks between the two groups

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orally take a dose of 5mg of dapagliflozin once a day before or after breakfast in addition to the medicines taken at time of consenting. If the blood glucose levels are high in patients after a month, it can be raised the dose of dapagliflozin to 10 mg once a day.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	1)Type 2 diabetic patients with insufficient glycemic control (HbA1c 7.0 to 10.0%) and BMI 22 kg/m2 and over 2)Patients who are administrating more than or equal to 750mg of metformin, or who aren't receiving metformin thrapy 3)over 20 and under 65 years old 4)outpatient 5)male and female
Key exclusion criteria	1)patients who administrating less than 750mg of metformin 2)patients who receive insulin injection therapy 3)hypersensitivity to study drugs on this study, 4)severe ketosis and diabetic coma or pre-coma 5)serious infective diseases, serious injury, pre- and per-operation 6)pregnancy, nursing woman or possibly pregnant woman 7)moderate or severe renal dysfunction (eGFR: less than 30 mL/min/1.73m2) 8)patients who receive steroids, growth hormone secretagogue, sex hormone agents 9)patients who are inadequate to enter this study due to the other reasons by physician's judgments
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Yasushi Middle name Last name Tanaka
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL	044-977-8111
Email	y2tanaka@marianna-u.ac.jp

Public contact
Name of contact person	1st name Hisashi Middle name Last name Fukuda
Organization	St. Marianna University School of Medicine
Division name	Division of Metabolism and Endocrinology, Department of Internal Medicine
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL	044-977-8111
Homepage URL
Email	h2fukuda@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	1)AstraZeneca K.K. 2)ONO PHARMACEUTICAL CO., LTD.
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	Bioethics Committee of St. Marianna University
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel	044-977-8111
Email	soumu@marianna-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

Other administrative information
Date of disclosure of the study information	2019 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	Preinitiation
Date of protocol fixation	2017 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date	2017 Year 12 Month 20 Day
Last follow-up date	2020 Year 03 Month 31 Day
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 18 Day
Last modified on	2020 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034219