UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016198 |
|---|---|
| Receipt number | R000018792 |
| Scientific Title | Examination of liver function improvement effect by administering a Ipragliflozin. |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2021/10/22 11:23:04 |
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Basic information
Public title
Examination of liver function improvement effect by administering a Ipragliflozin.
Acronym
Examination of liver function improvement effect by administering a Ipragliflozin.
Scientific Title
Examination of liver function improvement effect by administering a Ipragliflozin.
Scientific Title:Acronym
Examination of liver function improvement effect by administering a Ipragliflozin.
Region
| Japan |
Condition
Condition
Diabetic
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of liver function improving effect by administering a Ipragliflozin on patients with chronic liver disease complicated with diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AST,ALT,HbA1c,Fasting blood glucose or random blood glucose,IRI,BMI,Plt,TC,LDL-C,HDL-C,TG
Key secondary outcomes
AFP,PIVKA2,Hyaluronic acid (limited to patients with chronic hepatitis)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After registration, patients are administered Ipragliflozin. (trade name: Sugura) If you do not achieve the blood glucose effect goal, patients can be used in combination with other drugs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnostic criteria of diabetes (to comply with diabetes diagnostic criteria of Japan Diabetes Society)
- Early morning fasting blood glucose level 126mg/over
-75gOGTT (2-hour value)200mg/dl over
- Random blood glucose level 200mg/dl over
- HbA1c(NGSP)6.5%over
Key exclusion criteria
- Phlebotomy treatment patients
- Patients with a history of heart failure patients and heart failure
- Patients with a history of cerebral infarction
- Patients with severe ketosis, diabetic coma or precoma, of type 1 diabetes
- Patients with severe liver dysfunction (attending physician judgment)
- Patients with severe renal dysfunction (dialysis example or GFR <10-30ml/min)
- Severe infection, before and after surgery, patients with severe trauma
- Patients with a history of hypersensitivity to components of this drug
- Women that might be pregnant or pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakao |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7481
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakao |
Organization
Nagasaki University Hospital
Division name
Gastroenterology
Zip code
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7481
Homepage URL
hmiya0629@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
井上病院、おにつか内科、カリタス中央診療所、健康保険諫早総合病院、原爆諫早病院、光晴会病院、
済生会長崎病院、十善会病院、長崎原爆病院、長崎市立市民病院、長崎大学病院
長崎みどり病院、虹が丘病院、三菱長崎病院、山根内科胃腸科医院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | 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
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018792
| 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 |
