UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039361
Receipt number R000044887
Scientific Title The Effect of SGLT2 inhibitors on blood glucose variability in patients with type 1 diabetes
Date of disclosure of the study information 2020/02/02
Last modified on 2020/08/07 12:54:27

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Basic information

Public title

The Effect of SGLT2 inhibitors on blood glucose variability in patients with type 1 diabetes

Acronym

SGLT2i and glucose variability in T1DM

Scientific Title

The Effect of SGLT2 inhibitors on blood glucose variability in patients with type 1 diabetes

Scientific Title:Acronym

SGLT2i and glucose variability in T1DM

Region

Japan


Condition

Condition

type 1 diabetes mellitus

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the efficacy and safety of SGLT2 inhibitors in patients with type 1 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change in day-to-day and daily blood glucose variability

Key secondary outcomes

1 Blood and urine test (HbA1c, UACR, etc)
2 Body weight, Body mass index
3 Blood pressure
4 insulin dose
5 Adverse events


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

1) Patients with type 1 diabetes who are treated in Hokkaido University Hospital or collaborate hospitals from December 2018 to June 2020.
2) Patients with type 1 diabetes who have been treated with SGLT2 inhibitors for more than 12 weeks.

Key exclusion criteria

Patients who were thought to be inappropriate to enter this study for some reasons by physician's judgments

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hideaki
Middle name
Last name Miyoshi

Organization

Hokkaido University Faculty of Medicine and Graduate School of Medicine

Division name

Division of Diabetes and Obesity

Zip code

060-8638

Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

001-716-1161

Email

hmiyoshi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Hideaki
Middle name
Last name Miyoshi

Organization

Hokkaido University Faculty of Medicine and Graduate School of Medicine

Division name

Division of Diabetes and Obesity

Zip code

060-8638

Address

Nishi 5, Kita 14, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-8192

Homepage URL


Email

hmiyoshi@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Hospital

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

Hokkaido University Hospital Divison of Clinical Research Administration

Address

Nishi 5, Kita 14, Kita-Ku, Sapporo, Hokkaido, Japan

Tel

011-706-7636

Email

crjimu@med.hokudai.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

栗原内科クリニック(北海道)、青木内科クリニック(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 02 Month 02 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

30

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

2018 Year 11 Month 25 Day

Date of IRB

2019 Year 12 Month 11 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 02 Month 02 Day

Last modified on

2020 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044887


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name