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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023035
Receipt No. 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

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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
Email 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
Email qol-study@n-place.co.jp

Sponsor
Institute The Institute for Adult Diseases, Asahi Life Foundation
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026550

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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