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
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
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
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
