UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018979 |
|---|---|
| Receipt number | 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 11:01:01 |
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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
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
morihiro@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
