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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018979
Receipt No. R000021955
Scientific Title Non-inferiority of iPragliflozin and metformin on glucose metabolism, pleiotropic effects and safety in type2 diabetes
Date of disclosure of the study information 2015/09/11
Last modified on 2016/09/12

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Basic information
Public title Non-inferiority of iPragliflozin and metformin
on glucose metabolism, pleiotropic effects and safety in type2 diabetes
Acronym Effects of iPragliflozin on glucose metabolism and pleiotropic effects
Scientific Title Non-inferiority of iPragliflozin and metformin
on glucose metabolism, pleiotropic effects and safety in type2 diabetes
Scientific Title:Acronym Effects of iPragliflozin on glucose metabolism and pleiotropic effects
Region
Japan

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

Objectives
Narrative objectives1 To compare with ipragliflozin and metformin on glucose metabolism, pleiotropic effects and safety in type2 diabetes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in glucose metabolism at 14days after treatment
Key secondary outcomes (1) Changes in the variables listed below.
1-lipid profile
2-bome metabolism
3-renal function
4-urinanalysis
(2) safety

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 Ipragliflozin 50 mg/day (6months)
Interventions/Control_2 Metformin 750mg 3X/day(4days), 1500 mg 3X/day(5 days), 2250mg 3X/day(6months)
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)Diagnosed as type 2 diabetes
(2)20=<informed conscent age<75
(3)22.0=<BMI
(4) With estimated glomerular function >= 60 ml/min/1.73m2
(5)Subjects who treatment without SGLT2 inhibitors and biguanide
(6)Subjects who give consent document about participation in the clinical study
Key exclusion criteria (1) With diabetic ketoacidosis, diabetic coma and type 1 diabetes
(2) With infection
(3)Has arteriosclerotic disease (myocardial infarction, stroke and so on) and history of them
(4) Heavy use of alcohol
(5) Considered as inadequate by the investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Mori
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Homepage URL
Email morihiro@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization Merck and Co., Inc., Kenilworth, N.J., U.S.A.
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
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

Other administrative information
Date of disclosure of the study information
2015 Year 09 Month 11 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 Enrolling by invitation
Date of protocol fixation
2014 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 26 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 09 Month 11 Day
Last modified on
2016 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021955

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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