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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016198
Receipt No. 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 2016/07/05

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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
Email 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
Email hmiya0629@yahoo.co.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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
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 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 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 01 Month 13 Day
Last modified on
2016 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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