UMIN-CTR Clinical Trial

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

Type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

The Institute for Adult Diseases, Asahi Life Foundation

Institute

Department

Personal name

Organization

Taisho Toyama Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2016

Year

07

Month

11

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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