UMIN-CTR Clinical Trial

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
Email	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
Email	kyuyong-cho@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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