UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023035 |
|---|---|
| Receipt number | R000026550 |
| Scientific Title | Evaluation of the efficacy and safety of luseogliflozin and changes in QOL |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2019/06/02 15:48:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the efficacy and safety of luseogliflozin and changes in QOL
Acronym
Evaluation of the efficacy and safety of luseogliflozin and changes in QOL (Lusefi QOL study)
Scientific Title
Evaluation of the efficacy and safety of luseogliflozin and changes in QOL
Scientific Title:Acronym
Evaluation of the efficacy and safety of luseogliflozin and changes in QOL (Lusefi QOL study)
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 evaluate the efficacy and safety of luseogliflozin and changes in QOL in Japanese patients with type 2 diabetes mellitus.
To examine the factors that influence to QOL by exploratory analysis.
Basic objectives2
Others
Basic objectives -Others
To evaluate changes in QOL by the treatment with a SGLT2 inhibitor in Japanese patients with type 2 diabetes mellitus
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in QOL from 0 - 24 weeks:
QOL to be assessed using the following questionnaires:
DTSQ
SGLT2i-Q (SGLT2 inhibitor
Questionnaire : original questionnaire)
Key secondary outcomes
1) Changes in QOL from 0 - 12 weeks (DTSQ, SGLT2i-Q)
2) Body weight, BMI, blood pressure, abdominal circumference, pulse rate
3) Blood tests
HbA1c, fasting blood glucose, triglycerides, HDL-C, uric acid, AST, ALT, gamma-GTP, red blood cells, Hb, Ht, white blood cells, platelets, Cr, albumin, Na, Cl, K, BUN, osmotic pressure, eGFR
4) Urinalysis
(Qualitative) urinary protein, urinary glucose, uric blood, urobilinogen, specific gravity
(Quantitative) Na, Cl, K, Cr, UUN,
urinary glucose, urinary protein, urinary osmotic pressure
5) Measurement of 24-hr urine volume/ liquid intake
24-hr urine volume, 24-hr liquid intake, urination frequency (24-hr, daytime, nighttime)
6) Scoring assessments
Proportion of patients with improvement in metabolic syndrome
Fatty Liver Index
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
Oral administration of luseogliflozin 2.5 mg once daily before or after breakfast for 28 weeks
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 HbA1c (NGSP value) from >=6.9% to <=10.5% at screening
2) Patients receiving certain dietary therapy continuously from at least 12 weeks prior to the start of administration of the study drug
3) Patients not taking diabetic medication in period from at least 12 weeks prior to the start of administration, or taking diabetic medication continuously from at least 12 weeks beforehand with the same dosage and administration
4) Patients aged >=20 years at time of obtaining written informed consent
5) Patients who are capable of walking unassisted
6) Patients who have been explained details of the study, understood them, and given written informed consent for participation.
Key exclusion criteria
1) Patients with diabetes other than type 2 diabetes
2) Patients with a history of cardiovascular events such as cerebral infarction and myocardial infarction.
3) Patients with serious renal or hepatic dysfunction
4) Patients with malignant tumors (those who have a history of malignant tumors but are currently receiving no treatment and had no recurrence, and those considered unlikely to have any recurrence during the study period are eligible for the study).
5) Patients with repeated genital or urinary tract infections
6) Patients with eGFR <=30 mL/min/1.73 m2
7) Patients with BMI <=20
8) Patients for whom dosage and administration of concomitant antidiabetic drugs have been changed within the 12 weeks prior to the start of administration of the study drug.
9) Patients who have administered a SGLT2 inhibitor within 6 months prior to the start of administration of the study drug
10) Patients whose answers to the questionnaire at week 0 were not collected before the start of administration.
11) Patients deemed unsuitable for participation in the study by the investigator or sub-investigator due to other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Iwamoto |
Organization
The Institute for Adult Diseases, Asahi Life Foundation
Division name
Director
Zip code
Address
Sunaga Bldg., 2-2-6 Nihonbashi Bakurocho, Chuo-ku, Tokyo
TEL
03-3639-5501
a-kushiyama@asahi-life.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kou Kayukawa |
Organization
Nouvelle Place Inc.
Division name
Research Management Office
Zip code
Address
14th floor, Toranomon Towers Office, 4-1-28 Toranomon, Minato-ku, Tokyo
TEL
03-6680-2525
Homepage URL
qol-study@n-place.co.jp
Sponsor or person
Institute
The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tomonaga Clinic, Center for Diabetes and lifestyle-related diseases; Mitsui Memorial Hospital; Tanaka Internal Medicine Omiya Diabetes, Endocrinology and Metabolism Clinic; Shinjuku Mitsui Building Clinic; University of Toyama; Higashi Kurume Ekimae Clinic; Tokyo Gakugei University; Genki Plaza Medical Center For Health Care; Kumanomae Nishimura Medical Clinic; Tokyo Yamate Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
朝日生命成人病研究所附属医院（東京都）、ともながクリニック糖尿病・生活習慣病センター（東京都）、三井記念病院（東京都）、田中内科 大宮糖尿病クリニック（埼玉県）、新宿三井ビルクリニック（東京都）、熊野前にしむら内科クリニック（東京都）、東京山手メディカルセンター（東京都）
The Institute for Adult Diseases, Asahi Life Foundation (Tokyo), Tomonaga Clinic, Center for Diabetes and lifestyle-related diseases (Tokyo), Mitsui Memorial Hospital (Tokyo), Tanaka Internal Medicine Omiya Diabetes, Endocrinology and Metabolism Clinic (Saitama), Shinjuku Mitsui Building Clinic (Tokyo), Kumanomae Nishimura Medical Clinic (Tokyo),Tokyo Yamate Medical Center (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
64
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
Main results already published
Date of protocol fixation
| 2016 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 11 | Month | 02 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026550
