UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043061
Receipt number R000049162
Scientific Title STRIDE Study to evaluate the effect of Tofogliflozin on VRH In T2DM using ECG
Date of disclosure of the study information 2021/01/25
Last modified on 2023/12/28 12:18:12

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Basic information

Public title

STRIDE
Study to evaluate the effect of Tofogliflozin
on VRH In T2DM using ECG

Acronym

STRIDE

Scientific Title

STRIDE
Study to evaluate the effect of Tofogliflozin
on VRH In T2DM using ECG

Scientific Title:Acronym

STRIDE

Region

Japan


Condition

Condition

Type2 diabetes mellitus with obesity and high blood pressure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the effects of tofogliflozin on
ventricular muscle repolarization heterogeneity and related factors in type 2 diabetic patients with obesity and high blood pressure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Change of QTcd from baseline

Key secondary outcomes

1) Changes of QTcd and TpTe from baseline at 24 and 52 weeks of administration
2) Evaluation of the relationship between QTcd / TpTe and various factors at 24 and
52 weeks of administration
3) Changes from baseline in various factors at 8, 24, and 52 weeks of administration
4) 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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes mellitus
2) Administered tofogliflozin within 8 weeks
3) Blood Pressure >= 130/80 mmHg
4) BMI >= 25 kg/m2
5) Patients undergoing electrocardiography
within 12 weeks
6) 20 years or older and under 80 years

Key exclusion criteria

1) History of hypersensitivity to tofogliflozin
2) Severe ketosis, diabetic coma or precoma
3) Ssevere infections, before and after
surgery, and with serious trauma
4) Taking tofogliflozin in the past
5) Atrial fibrillation
6) With artificial pacemaker, or implantable
cardioverter-defibrillator
7) Chronic kidney disease (CKD) stage 4
and 5
8) Pregnancy, lactating women, patients with the intention of becoming pregnant
9) Patients judged inappropriate

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Masaya
Middle name
Last name Tanno

Organization

Sapporo Medical University School of
Medicine

Division name

Department of Cardiovascular, Renal and Metabolic Medicine

Zip code

060-8543

Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Email

tannom@sapmed.ac.jp


Public contact

Name of contact person

1st name Tatsuya
Middle name
Last name Sato

Organization

Sapporo Medical University School of Medicine

Division name

Department of Cellular Physiology and Signal Transduction / Department of Cardiovascular, Renal and

Zip code

060-8543

Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

sato.tatsuya@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Kowa Company, Ltd.

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

Sapporo Medical University Hospital Clinical Research Ethics Committee

Address

S1, W17, Chuo-ku, Sapporo, Hokkaido, Japan

Tel

011-611-2111

Email

ji-rskk@sapmed.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

王子総合病院(北海道) Oji General Hospital
JR札幌病院(北海道) JR Sapporo Hospital
製鉄記念室蘭病院(北海道) Steel Memorial Muroran Hospital


Other administrative information

Date of disclosure of the study information

2021 Year 01 Month 25 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

Enrolling by invitation

Date of protocol fixation

2020 Year 09 Month 10 Day

Date of IRB

2020 Year 09 Month 10 Day

Anticipated trial start date

2021 Year 02 Month 01 Day

Last follow-up date

2024 Year 05 Month 31 Day

Date of closure to data entry

2024 Year 06 Month 30 Day

Date trial data considered complete

2024 Year 07 Month 30 Day

Date analysis concluded

2024 Year 12 Month 01 Day


Other

Other related information

Recruitment of study subjects:
We will enroll all the patients who (1) visit the hospitals participating in this study between Feburuary 2021 and April 2024, (2) are eligible for enrollement in this study and
(3)give informed consent to participate in
this study.
Recording of 12-lead ECG is mandatory.
QTcd and TpTe in the ECGs will be
measured by principal and co-investigators of this study in our hospital and their
average value will be analyzed


Management information

Registered date

2021 Year 01 Month 20 Day

Last modified on

2023 Year 12 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049162


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name