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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043595
Receipt No. R000049727
Scientific Title Effects of SGLT2 inhibitor Luseogliflozin on a lipid profile in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2021/04/06
Last modified on 2021/03/11

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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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