UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050228
Receipt number R000057140
Scientific Title Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices
Date of disclosure of the study information 2023/04/01
Last modified on 2023/02/03 15:12:17

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Basic information

Public title

Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices

Acronym

Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices

Scientific Title

Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices

Scientific Title:Acronym

Observational Study of the effect of SGLT2 inhibitor on Glycemic Control Indices

Region

Japan


Condition

Condition

diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Establishment of the glycemic control index appropriate for the patients taking SGLT2 inhibitor

Basic objectives2

Others

Basic objectives -Others

The effects on glycemic control indices by SGLT2 inhibitor

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of GA/HbA1c ratio between patients taking SGLT2 inhibitor and those not

Key secondary outcomes

Comparison of glycemic control indices between patients taking SGLT2 inhibitor and those not
Exploratory analysis of factors contributing to glycemic control indices


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who visited Nagoya university hospital or the joint research institute between April 17,2014 and December 31,2022
Those with the data both HbA1c and glycated albumin measured simultaneously
Those with the data both HbA1c and glucose management indicator measured simultaneously

Key exclusion criteria

None

Target sample size

4250


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Arima

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Endocrinology and Diabetes

Zip code

466-8560

Address

65 Tsurumai-Cho, Showa-Ku, Nagoya

TEL

052-744-2142

Email

arima105@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Onoue

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Endocrinology and Diabetes

Zip code

466-8560

Address

65 Tsurumai-Cho, Showa-Ku, Nagoya

TEL

052-744-2142

Homepage URL


Email

t-onoue@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Institutional Review Board of the Ethics Committee of Nagoya University

Address

65 Tsurumai-Cho, Showa-Ku, Nagoya

Tel

052-741-2111

Email

ethics@med.nagoya-u.ac.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

2023 Year 04 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

2023 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We aim to clarify the SGLT2 inhibitor's effects on glycemic control indices by conducting a retrospective cohort study of patients with the data both HbA1c and other glycemic control indices measured simultaneously.


Management information

Registered date

2023 Year 02 Month 03 Day

Last modified on

2023 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057140


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name