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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031451
Receipt No. 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 2018/08/26

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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 diastolic blood pressure during 24hr
Changes in average of diastolic blood pressure during the day-time section
M-value
Changes in heart rate
Changes in laboratory test value

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
80 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.
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
Middle name
Last name Hideaki Miyoshi
Organization Hokkaido University Hospital
Division name Department of Medicine II
Zip code
Address N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL 011-706-5915
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyu Yong Cho
Organization Hokkaido University Hospital
Division name Department of Medicine II/Clinical Research and Medical Innovation Center
Zip code
Address N14W5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan
TEL 011-706-5915
Homepage URL
Email kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Taisho Toyama 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
Address
Tel
Email

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
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
2018 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
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
2018 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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