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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025852
Receipt No. R000029676
Scientific Title Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Date of disclosure of the study information 2017/01/26
Last modified on 2019/04/05

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Basic information
Public title Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Acronym Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Scientific Title Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Scientific Title:Acronym Comparative of the effect about CAVI between Luseogliflozin and Amaryl in type2 diabetes
Region
Japan

Condition
Condition Type2 diabetes Mellitus
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 SGLT2 inhibitors have not only lower glucose but weight loss and lower blood pressure. These effect lead to preventing cardio vascular disease caused by diabetes. In this study, we compare about the effect for the risk of CVD by using CAVI, between Luseogliflozin, is one of the SGLT2 inhibitors, and amaryl, has showed improving the deta of CAVI.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We evaluate the variations of HbA1c and CAVI from the begining of treatment to week 24.
Key secondary outcomes We evaluate the variations of the following items from the begining of treatment to week 24.

Hight,body weight,girth of the abdomen,blood pressure,inbody,ABI,fasting plasma glucose,IRI,TC,TG,LDL-C,HDL-C,LPLmass,d-ROMs,keton body,urinalysis(general,glucose and albumin)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SGLT2 inhibitor(Luseogliflozin)
Interventions/Control_2 Amaryl(glimepiride)
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)Type2 diabetic patients
2)Patients whose BMI is over 25 and HbA1c is over 7.0% but under 8.5%
3)Patients using Biguanide, DPP4 inhibitor and/or GLP1 analog(it doesn't matter any dose)
Key exclusion criteria 1)Type1 diabetic patients or IDDM
2)Patients using insulin
3)Patients had cardiovascular disease or cerebrovascular disease in the past
4)Patients who are judged to be inadequate to use SGLT2 inhibitor
5)Patients with severe infections, patients before or after operations orhaving seriousexternal injuries
6)Patients with allergy to the ingredient(s) of these medicines(Luseogliflozin or amaryl)
7)Patients with severe renal dysfunction or end-stage renal disease undergoing artificial dialysis
8)Patients with severe liver dysfunction
9)Patients with
10)Pregnant women or lactating women
11)Patients who are judged to be inadequate to participate in this study by a doctor in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichiro Tatsuno
Organization Toho University Sakura Medical Center.
Division name Center of Diabetes, Endocrinology and Metabolism
Zip code
Address 564-1,Shimoshizu,Sakura-city,Chiba
TEL 043-462-8811
Email ichiro.tatsuno@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Tatsuno
Organization Toho University Sakura Medical Center.
Division name Center of Diabetes, Endocrinology and Metabolism
Zip code
Address 564-1,Shimoshizu,Sakura-city,Chiba
TEL 043-462-8811
Homepage URL
Email ichiro.tatsuno@med.toho-u.ac.jp

Sponsor
Institute Toho University Sakura Medical Center.
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 26 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
2016 Year 10 Month 01 Day
Date of IRB
2016 Year 08 Month 12 Day
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029676

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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