UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031451 |
|---|---|
| Receipt number | R000035907 |
| Scientific Title | Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study - |
| Date of disclosure of the study information | 2018/02/28 |
| Last modified on | 2021/11/29 12:56:04 |
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Basic information
Public title
Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study -
Acronym
Luseogliflozin ABPM study
Scientific Title
Study for the effect on blood pressure and heart rate fluctuation by switching from DPP-4 inhibitor to SGLT2 inhibitor Luseogliflozin in patients with type 2 diabetes. - multicenter, prospective, randomized, open-label, parallel group, comparison study -
Scientific Title:Acronym
Luseogliflozin ABPM study
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of switching DPP4 inhibitor to Luseogliflozin on blood pressure and heart rate fluctuation using 24 hour ambulatory blood pressure monitoring system in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in average of systolic blood pressure during the night-time section
Key secondary outcomes
Changes in average of diastolic blood pressure during the night-time section
Changes in average of systolic and diastolic blood pressure during 24 hr
Changes in average of systolic and diastolic blood pressure during the day-time section
Blood pressure fluctuation in the night section relative to the day section
M-value
Trough of systolic and diastolic blood pressure for 1 hour before the next dose
Changes in heart rate
Changes in laboratory test value
Relationship between blood pressure reduction and weight loss
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Switching from DPP4 inhibitor to Luseogliflozin
Interventions/Control_2
Continuing of DPP4 inhibitor
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) HbA1c 6.0-9.0%.
2) Patients with type 2 diabetes who have been taking DPP-4 inhibitors (except weekly agents) for 4 weeks.
3) Patients with hypertension(> 130/80 mmHg).
4) Written informed consent.
Key exclusion criteria
1) Patients with taking SGLT2 inhibitors.
2) Hypersensitivity to Luseogliflozin.
3) Uncontrolled diabetic retinopathy
4) Severe liver dysfunction, renal dysfunction, or heart failure
5) Pregnancy, nursing woman or possibly pregnant woman
6) Severe diabetic ketosis, diabetic coma
7) Severe infection, pre and post operation
, severe trauma
8) Deficiency of insulin secretion
9) BMI < 22kg/m2
10) eGFR < 30 ml/min
11) Patients with uncontrolled diet therapy.
12) Patients with irregular circadian rhythm.
13) Patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Miyoshi |
Organization
Hokkaido University
Division name
Division of Diabetes and Obesity, Graduate School of Medicine
Zip code
060-8638
Address
N15W7, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-8192
hmiyoshi@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University Hospital
Division name
Department of Medicine II/Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL
011-706-5915
Homepage URL
kyuyong-cho@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Clinical Research Administration, Hokkaido University Hospital
Address
N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
Tel
011-706-7636
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
北海道大学病院（北海道）、青木内科クリニック（北海道）、NTT東日本札幌病院（北海道）、栗原内科（北海道）、さっぽろ糖尿病・甲状腺クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/10/2/e034883.long
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0168822721004289?via%3Dihub
Number of participants that the trial has enrolled
68
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 09 | Month | 23 | Day |
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 | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035907
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