UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000026550