UMIN-CTR Clinical Trial

Basic information
Public title	Effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Acronym	Effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Scientific Title	Effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Scientific Title:Acronym	Effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Region	Japan

Condition
Condition	type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c levels, lipid profiles (total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, non HDL cholesterol, apoB, apoA-1, apoB/apoA-1 ratio, RLP cholesterol) 24 weeks after administration
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administer Luseogliflozin 2.5 mg once a day in the morning. When glycemic control is inadequate, the medicine can be increased up to 5 mg.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with type 2 diabetes mellitus who had received diet, exercise therapy, and glucose-lowering therapy for at least a month before participation and had a glycated hemoglobin level of at least 7.0% and no more than 10.0% 2) Patients with fasting plasma triglycerides at least 120 mg/dL and no more than 400 mg/dL 3) Patients with an estimated glomerular filtration rate (eGFR) at least 30 mL/min per 1.73m2 4) Patients who are 20 years old or older 5) Patients who have agreed to participate in this study 6)Patient with body mass index (BMI) 20 kg/m2 or more
Key exclusion criteria	1) Patients with type 1 diabetes mellitus 2) Patients who had current change in dose or usage of antidiabetic and dyslipidemia drugs within a month 3) Patients who currently used other SGLT2 inhibitor within a month of screening (Patients who have suspended using SGLT2 inhibitor for more than a month can participate. ) 4) Patients with a history of severe ketosis, diabetic coma, or precoma within six months before participation 5) Patients with proliferative retinopathy 6) Patients with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73m2 at screening, or patients who need renal dialysis 7) Patients with dysuria 8) Patients with urinary tract infections or genital infections 9) Patients who have severe infection, serious injury or who are before of after operation 10) Patients with a history of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, or severe heart disease (NYHA Class III-IV) within 6 months 11) Patients who are pregnant or breast-feeding or planning to become pregnant 12) Patients with severe liver disfunction (Child-Pugh score: at least 10 and no more than 15) 13) Patients with a history of allergy to Luseogliflozin 14) Patients who are judged to be inappropriate as a subject by an investigator
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Yuriko Middle name Last name Hajika
Organization	Minami Osaka Hospital
Division name	Internal Medicine
Zip code	559-0012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
TEL	06-6685-0221
Email	y.hajika@minamiosaka.com

Public contact
Name of contact person	1st name Yuriko Middle name Last name Hajika
Organization	Minami Osaka Hospital
Division name	Internal Medicine
Zip code	559-0012
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
TEL	06-6685-0221
Homepage URL
Email	y.hajika@minamiosaka.com

Sponsor
Institute	Minami Osaka Hospital Internal Medicine
Institute
Department

Funding Source
Organization	nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Minami Osaka Hospital
Address	1-18-18, Higashikagaya, Suminoe-ku, Osaka, Japan
Tel	06-6685-0221
Email	y.hajika@minamiosaka.com

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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 06 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 06 Day
Last follow-up date	2022 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	2021 Year 03 Month 11 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049727

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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