UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013921 |
|---|---|
| Receipt number | R000015659 |
| Scientific Title | Efficacy of ipragliflozin on glucose metabolism |
| Date of disclosure of the study information | 2014/05/16 |
| Last modified on | 2014/10/25 23:30:09 |
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Basic information
Public title
Efficacy of ipragliflozin on glucose metabolism
Acronym
Efficacy of ipragliflozin on glucose metabolism
Scientific Title
Efficacy of ipragliflozin on glucose metabolism
Scientific Title:Acronym
Efficacy of ipragliflozin on glucose metabolism
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the change of glucose metabolism after the treatment with ipragliflozin in type 2 diabetic patients with poor glycemic control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of glucose metabolism assessed by a 75-g oral glucose tolerance test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with ipragliflozin
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic patients with poor glycemic control
Key exclusion criteria
- severe hepatic, renal, and/or cardiac diseae
- contraindication to ipragliflozin
- pregnant or breast-feeding females
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Shiraiwa/Taka-aki Matsuoka |
Organization
Shiraiwa Medical Clinic/Osaka University Graduate School of Medicine
Division name
-/Dept of Metabolic Medicine
Zip code
Address
4-10-24, Hozenji, Kashiwara, Osaka, Japan/2-2, Yamadaoka, Suita, Osaka, Japan
TEL
072-971-1221
shiraiwa@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Takahara |
Organization
Osaka University Graduate School of Medicine
Division name
Dept of Metabolic Medicine
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3743
Homepage URL
takahara@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Shiraiwa Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dept of Metabolic Meidicine, Osaka University Graduate School of Medicine
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
白岩内科医院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 16 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 16 | 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
| 2014 | Year | 05 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015659
| 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 |
