UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028634
Receipt number R000032772
Scientific Title Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients
Date of disclosure of the study information 2017/09/01
Last modified on 2023/05/29 12:53:47

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Basic information

Public title

Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients

Acronym

Kansai - Collaborative Anti-atherothrombotic Medicine study group

Scientific Title

Multicenter trial of effects for glucometabolism, platelet activation marker and inflammatory marker by single or combinathin therapy with tofogliflozin and anagliptin in type 2 diabetic patients

Scientific Title:Acronym

Kansai - Collaborative Anti-atherothrombotic Medicine study group

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

pass

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of HbA1c during 24 weeks from baseline

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

tofogliflozin

Interventions/Control_2

anagliptin

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

95 years-old >

Gender

Male and Female

Key inclusion criteria

1. under treatment by dialy DPP-4 blocker
2. 7.5% < HbA1c < 9.0%
3. BMI > 18.0 kg/m2
4. 20 years < age < 95 years
5. written informed concent

Key exclusion criteria

1. type 1 diabetes or secondary diabetes
2. contraindication for medicine
3. allergy
4. eGFR < 30mL/min/1.73m2
5. AST or ALT > 120IU/L
6. history of appoplexy
7. pregnancy or lactationperiod
8. urinary infection, social disease
9. malignancy
10. inappropriate patients

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

First Department of Internal Medicine

Zip code


Address

2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan

TEL

0728042754

Email

nomurash@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

First Department of Internal Medicine

Zip code


Address

2-5-1, Shin-machi, Hirakata, Osaka 573-1010 Japan

TEL

0728042754

Homepage URL


Email

nomurash@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

pass

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 09 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

Preinitiation

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB

2017 Year 09 Month 01 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 08 Month 31 Day

Date trial data considered complete


Date analysis concluded

2020 Year 10 Month 01 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 10 Day

Last modified on

2023 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032772


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name