UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018792