UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025808
Receipt No. R000029679
Scientific Title Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Date of disclosure of the study information 2017/01/23
Last modified on 2018/01/24

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Acronym Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Scientific Title Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Scientific Title:Acronym Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change and percent change in AST, ALT, gamma-GTP, and HbA1c from baseline to 52 weeks
Key secondary outcomes 1) Change in the following items from baseline to 12 and 24 weeks
- AST, ALT, gamma-GTP, HbA1c
2) Change in the following items from baseline to 12, 24, and 52 weeks
- Fasting plasma glucose, HOMA-beta, HOMA-IR
- Body weight, BMI, Waist circumference, and Blood pressure
- NAFLD fibrosis score, FIB-4 index, FLI
3) Change in the following items from baseline to 24 and 52 weeks
- Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP
4) Change in IL-6 from baseline to 52 weeks

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 Oral administration of 2.5 mg luseogliflozin once a day, pre or post breakfast for 52 weeks
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged >=20, =<80 at consent
2) Poorly glycemic controlled patients who undergo diet/exercise therapy or treatment with hypoglycemic agents for at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 20 kg/m2
5) Provide written informed consent
6) With hepatic dysfunction (ALT>=31 IU/L)
Key exclusion criteria 1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With severe renal dysfunction (eGFR<30 mL/min/1.73m2)
5) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months
6) Receiving SGLT2 inhibitor
7) Nursing or pregnant or planning to become pregnant
8) Has hypersensitivity to luseogliflozin or any other excipients of luseogliflozin
9) Considered as inadequate by the investigator
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Seino
Organization Seino Internal Medicine Clinic
Division name Medical director
Zip code
Address 6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL 024-983-1024
Email kn7jh5@bma.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Seino
Organization Seino Internal Medicine Clinic
Division name Medical director
Zip code
Address 6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL 024-983-1024
Homepage URL
Email kn7jh5@bma.biglobe.ne.jp

Sponsor
Institute Seino Internal Medicine Clinic
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co., Ltd.
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 23 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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 16 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 23 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
2017 Year 01 Month 23 Day
Last modified on
2018 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.