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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032296
Receipt No. R000036393
Scientific Title Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Date of disclosure of the study information 2018/04/18
Last modified on 2018/04/17

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Basic information
Public title Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Acronym Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Scientific Title Effects of dapaglifrogine and metoformine in patients with type 2 diabetes:a randomized controlled study
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuzuru Ito
Organization Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama
TEL 045-787-2800
Email yito_yu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuzuru Ito
Organization Yokohama City University
Division name Department of Endocrinology and Metabolism
Zip code
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)

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 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

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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 13 Day
Date of IRB
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

Other
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

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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