UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043595 |
|---|---|
| Receipt number | 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 | 2021/08/04 18:29:13 |
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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
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
y.hajika@minamiosaka.com
Sponsor or person
Institute
Minami Osaka Hospital
Internal Medicine
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 06 | Day |
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 | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049727
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