UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032296 |
|---|---|
| Receipt number | 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 23:10:48 |
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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
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
yito_yu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036393
