UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Title of the study (Brief title)	Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to compare the effects of SGLT2 inhibitor with metoformine on glucose levels in Japanese type 2 diabetes patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvement in HbA1c after 24 weeks of treatment.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	dapaglifrogine 5-10mg/day for 24weeks
Interventions/Control_2	metoformine 500-1500mg/day for 24weeks
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)Outpatients diagnosed with type 2 diabetes, aged 20-75years old 2)Patients treated with diet therapy and execise therapy for 2months, and did not treated with metoformine or dapaglifrogine 3)Patients treated with oral hypoglycemic agent within 2 drags. 4)glycemic control: HbA1c >=7.0%,=<10.0% 5)Having provided voluntary written consent for participation in this study.
Key exclusion criteria	1)Patients diagnosed with Type 1 diabetes or secondary forms of diabetes 2)Patients with renal dysfunction (eGFR <45ml/min/1.73m2) 3)Patients with hepatic dysfunction(AST and/or ALT >3X upper limit of normal) 4)Patients with severe congestive heart failure, acute heart failure 5)Patients who are taking steroid medication 6) Patients with a history of diabetic ketoacidosis, diabetic coma during the last 6 months 7)Patients with active malignant neoplasm 8)Patients with severe infection or injury 9)Patients with hypersensitivity to metoformine or dapaglifrogine 10) Patients who are pregnant,lactating or willing to be pregnant during this study 11) Patients who have taken SGLT2 or metoformine within 8 weeks prior to enroll, or who are already taking SGLT2 or metoformine 12)Patients who are unable to obtain informed consent to this study 13)Patients who are inadequacy of using this therapy
Target sample size	100

Research contact person
Name of lead principal investigator	Yuzuru Ito
Organization	Yokohama City University
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Email	yito_yu@yokohama-cu.ac.jp

Public contact
Name of contact person	Yuzuru Ito
Organization	Yokohama City University
Division name	Department of Endocrinology and Metabolism
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2800
Homepage URL
Email	yito_yu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	横浜市立大学病院（神奈川県）Yokohama City University Hospital(Kanagawa) 横浜市立大学附属市民総合医療センター（神奈川県）Yokohama City University Medical Center(Kanagawa) 済生会若草病院（神奈川県）Wakakusa Hospital(Kanagawa) 藤沢市民病院（神奈川県） Fujisawa City Hospital(Kanagawa) 平塚市民病院（神奈川県）Hiratsuka City Hospital(Kanagawa)

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 18 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 13 Day
Anticipated trial start date	2018 Year 04 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 04 Month 17 Day
Last modified on	2018 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036393