UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015361
Receipt number R000017868
Scientific Title Vascular event risks of DPP-4 inhibitors in Japanese patients with type 2 diabetes: a comparative effectiveness study using a large scale hospital database
Date of disclosure of the study information 2014/10/09
Last modified on 2016/04/13 16:44:44

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Basic information

Public title

Vascular event risks of DPP-4 inhibitors in Japanese patients with type 2 diabetes: a comparative effectiveness study using a large scale hospital database

Acronym

Vascular risks of DPP-4 inhibitors

Scientific Title

Vascular event risks of DPP-4 inhibitors in Japanese patients with type 2 diabetes: a comparative effectiveness study using a large scale hospital database

Scientific Title:Acronym

Vascular risks of DPP-4 inhibitors

Region

Japan


Condition

Condition

Type 2 Diabetes

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Estimation of cardio/cerebrovascular risks of DPP-4 inhibitors in Japanese patients with tyep 2 diabetes using a large-scale Japanese hospital database including administrative and laboratory data.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite endpoint including cardiac infarction, cerebral infarction, and cerebral hemorrhage.

Key secondary outcomes

individual vascular events including cardiac infarction, cerebral infarction, and cerebral hemorrhage.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Having diagnosis codes for type 2 diabetes (ICD-10 E11, E12, E13, and E14)
2. New users of anti-diabetic medicines

Key exclusion criteria

2. Having diagnosis code of ICD-10 E10 for type 1 diabetes

Target sample size

100000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisashi Urushihara

Organization

Keio University

Division name

Drug Development and Regulatory Science, Faculty of Pharmacy

Zip code


Address

1-5-30, Shiba-Koen, Minato-Ku, Tokyo

TEL

03-5400-2649

Email

urushihara-hs@pha.keio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Urushihara

Organization

Keio University

Division name

Drug Development and Regulatory Science, Faculty of Pharmacy

Zip code


Address

1-5-30, Shiba-Koen, Minato-Ku, Tokyo

TEL

03-5400-2649

Homepage URL


Email

urushihara-hs@pha.keio.ac.jp


Sponsor or person

Institute

Drug Development and Regulatory Science, Faculty of Pharmacy
Keio University

Institute

Department

Personal name



Funding Source

Organization

Keio University

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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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

2014 Year 09 Month 17 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2015 Year 02 Month 01 Day

Date of closure to data entry

2015 Year 02 Month 18 Day

Date trial data considered complete

2015 Year 02 Month 28 Day

Date analysis concluded

2015 Year 02 Month 28 Day


Other

Other related information

Retrospective cohort analysis using the EBM provider, a hospital information database covering administrative, and diagnosis-procedure combination data and laboratory data from 147 secondary medical care hospitals, totaling more than 7.5 million patients.
DPP-4 inhibitor group and other diabetic medication group excluding SGLT-2 and insulin were compared.


Management information

Registered date

2014 Year 10 Month 07 Day

Last modified on

2016 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name