UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045373 |
|---|---|
| Receipt number | R000051803 |
| Scientific Title | Efficacy and Safety of Increasing Dose of Luceogliflozin in Type 2 Diabetic Patients with Inadequate Glycemic Control |
| Date of disclosure of the study information | 2021/09/03 |
| Last modified on | 2023/03/06 14:11:18 |
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Basic information
Public title
Efficacy and Safety of Increasing Dose of Luceogliflozin in Type 2 Diabetic Patients with Inadequate Glycemic Control
Acronym
Efficacy and Safety of Increasing Dose of Luceogliflozin
Scientific Title
Efficacy and Safety of Increasing Dose of Luceogliflozin in Type 2 Diabetic Patients with Inadequate Glycemic Control
Scientific Title:Acronym
Efficacy and Safety of Increasing Dose of Luceogliflozin
Region
| Japan |
Condition
Condition
Type2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among the SGLT2 inhibitors, luseo-gliflozin (LUSEO) is the lowest dose of 2.5 mg and can be increased to 5 mg. In this study, we compared the effects of LUSE 2.5 mg and 5 mg in two groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c before and after luseogliflozin administration (2.5 mg/day, 5 mg/day)
Key secondary outcomes
Changes in (fasting) blood glucose, (fasting )insulin, triglycerides, LDL-cholesterol, HDL-cholesterol, eGFR, uric acid, AST, ALT, ganma-GTP, DBP, and SBP before and after luseogliflozin administration (2.5 mg/day, 5 mg/day)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with type 2 diabetes mellitus with inadequate glycemic control who are taking diet and exercise or oral hypoglycemic agents other than SGLT2 inhibitors will receive luseogliflozin 2.5 mg/day for at least 3 months. Thereafter, patients will be randomly assigned by the envelope method to the 2.5 mg/day group (2.5 mg in the morning) or the 5 mg/day group (5 mg in the morning) for 3 months. In 2.5 mg/day group, blood and urine samples will be collected at three time points: before luseogliflozin administration (0 months), at least 3 months after enrollment, and 3 months after randomization.
Interventions/Control_2
Patients with type 2 diabetes mellitus with inadequate glycemic control who are taking diet and exercise or oral hypoglycemic agents other than SGLT2 inhibitors will receive luseogliflozin 2.5 mg/day for at least 3 months. Thereafter, patients will be randomly assigned by the envelope method to the 2.5 mg/day group (2.5 mg in the morning) or the 5 mg/day group (5 mg in the morning) for 3 months. In 5 mg/day group, blood and urine samples will be collected at three time points: before luseogliflozin administration (0 months), at least 3 months after enrollment, and 3 months after randomization.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible.
(1) Age 20 years or older, 89 years or
younger (regardless of gender)
(2) Patients with an HbA1c of 7.0% or higher
(3) Patients who can give their consent to participate in this study.
Key exclusion criteria
(1) Patients on insulin
(2) Pregnant women or women who may be pregnant
(3) Patients with a history of hypersensitivity to luseogliflozin
(4) Pregnant women or women who may be pregnant, women who wish to become pregnant, and women who are breast-feeding
(5) Others who are judged by the investigator to be inappropriate for this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Arao |
Organization
Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Health and Safety Organization
Division name
Department Internal Medicine of Diabetes, Hematology and Collagen Diseases
Zip code
801-8502
Address
3-1Higasiminatomachi,Moji-ku,Kitakyushu City, Fukuoka
TEL
0933313461
t-arao@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Arao |
Organization
Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Health and Safety Organization
Division name
Department Internal Medicine of Diabetes, Hematology and Collagen Diseases
Zip code
801-8502
Address
3-1Higasiminatomachi,Moji-ku,Kitakyushu City, Fukuoka
TEL
0933313461
Homepage URL
http://www.mojih.johas.go.jp
t-arao@med.uoeh-u.ac.jp
Sponsor or person
Institute
Department Internal Medicine of Diabetes, Hematology and Collagen Diseases,Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Healthand Safety Organization
Institute
Department
Personal name
Funding Source
Organization
Department Internal Medicine of Diabetes, Hematology and Collagen Diseases,Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Healthand Safety Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The First Department of Internal Medicine, University of Occupational and Environmental Health, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Moji Medical Center, Kyushu Rosai Hospital, Japan Labor Healthand Safety Organization
Address
3-1 Higasiminatomachi,Moji-ku,Kitakyushu City, Fukuoka
Tel
0933313461
t-arao@med.uoeh-u.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
独立行政法人労働者健康安全機構九州労災病院 門司メディカルセンター
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 03 | Day |
Related information
URL releasing protocol
http://www.mojih.johas.go.jp
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/
Number of participants that the trial has enrolled
40
Results
In T2DM patients with inadequate glycemic control who were receiving Luseogliflozin 2.5m, increasing the dose to Luseogliflozin 5mg safely improved glycemic control. Increasing the dose of Luseogliflozin from 2.5 mg to 5 mg may be an effective treatment option in T2DM with inadequate glycemic control.
Results date posted
| 2021 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patient background: 40 cases in all cases ((1) 20 cases in group, (2) 20 cases in group, male / female: 23/17), age 72.8 years, DM illness period 12.5 years, BMI 24.1, FPG 163.5, HbA1c 8.0, SBP 150.1, DBP 78.5, AST 25.8, ALT 28.0, GTP 41.8, eGFR 65.9, LDL-C 103.0, TG 165.4, HDL-C 53.4, none of which was significantly different between the two groups.
Participant flow
Tadashi Arao,
Yosuke Okada,
Akira Kurzumi,
Yoshiya Tanaka
Adverse events
During the evaluation period, there was 1 adverse drug reaction (urinary tract infection) in Group1.
Outcome measures
Amount of change: (shown in the order of (1) group and (2) group below) Primary endpoint: HbA1c: -0.09, -0.51 (p<0.001) and significant improvement in group (2). Secondary endpoints: BW: -0.52, -0.42 (p = 0.849), BMI: -0.21, -0.11, SBP: -7.1, -1.4, DBP: 3.4, -2.7 (p = 0.316), FPG: 3.9, -2.7 (p = 0.199), TG: -36.4, 16.6 (p = 0.286), LDL-C: 4.5, -3.7 (p = 0.122), HDL-C: 1.3, -0.1 (p = 0.683), eGFR: 0.3, -0.4 (p = 0.379), AST: 0.8, -0.8 (p = 0.652), ALT: 2.5, -0.5 (p = 0.321), GTP: -0.5, -0.3 (p = 0.811), all significantly different none. 3) The amount of change in HbA1c was significantly correlated with baseline HbA1c (p = 0.02, r = -0.516). 4) ROC analysis showed that the cut off for HbA1c improvement was 7.8% at baseline in the 5 mg dose-increased group (sensitivity 70.6%, specificity 66.7%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051803
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