UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032496
Receipt number R000037064
Scientific Title Comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus
Date of disclosure of the study information 2018/05/09
Last modified on 2021/05/10 15:06:03

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Basic information

Public title

Comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus

Acronym

Comparative efficacy and safety of antidiabetic drugs

Scientific Title

Comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus

Scientific Title:Acronym

Comparative efficacy and safety of antidiabetic drugs

Region

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess comparative efficacy and safety of antidiabetic drugs in treating diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mortality, macrovascular event, microvascular event, dialysis, sepsis, diabetic ketoacidosis, amputation, fracture, and severe hypoglycemia

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

1 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

New user receiving or dispensed prescription of DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 agonists, including fixed-dose combination (FDC) products containing these medication groups
T2DM diagnosis on or prior to the index date

Key exclusion criteria

Patients with a T1DM diagnosis
Patients with gestational diabetes within 1 year before index date

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Tomohide
Middle name
Last name Yamada

Organization

The University of Tokyo

Division name

Department of Diabetes and Metabolic Diseases

Zip code

1138655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-2575

Email

YAMADAT-INT@h.u-tokyo.ac.jp


Public contact

Name of contact person

1st name Tomohide
Middle name
Last name Yamada

Organization

The University of Tokyo

Division name

Health service center

Zip code

1138655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo

TEL

03-5841-2575

Homepage URL


Email

YAMADAT-INT@h.u-tokyo.ac.jp


Sponsor or person

Institute

The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo

Address

7-3-1, Hongo, Bunkyoku, Tokyo

Tel

1138655

Email

bqx07367@yahoo.co.jp


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

2018 Year 05 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

Preinitiation

Date of protocol fixation

2018 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2020 Year 10 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The study will be conducted using anonymous data from claims, medical records and national health registries.


Management information

Registered date

2018 Year 05 Month 07 Day

Last modified on

2021 Year 05 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037064


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name