UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025852
Receipt number 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 18:41:18

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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 or person

Institute

Toho University Sakura Medical Center.

Institute

Department

Personal name



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

Value
https://center6.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