UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036202
Receipt number R000040416
Scientific Title Longitudinal analysis of bone microstructural changes under luseogliflozin treatment using second-generation High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) in elderly patients with type 2 diabetes
Date of disclosure of the study information 2019/04/01
Last modified on 2024/03/08 10:38:56

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Basic information

Public title

Longitudinal analysis of bone microstructural changes under luseogliflozin treatment using second-generation High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) in elderly patients with type 2 diabetes

Acronym

Bone microstructural changse under luseogliflozin treatment

Scientific Title

Longitudinal analysis of bone microstructural changes under luseogliflozin treatment using second-generation High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) in elderly patients with type 2 diabetes

Scientific Title:Acronym

Bone microstructural changse under luseogliflozin treatment

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate bone quality change by using HR-pQCT in type 2 diabetes under luseogliflozin treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

Changes in the predicted bone strength of radius and tibia calculated using HR-pQCT (kN/mm)

Key secondary outcomes

Changes in the values of blood and biochemical tests.
Changes in the bone mineral density at lumbar spine, femur, radius measured by dual-energy X-ray absorptiometry.
Incidence of vertebral fracture or femoral fracture.
Changes in the values of bone metabolic markers.
Changes in the values related with cortical bone structure, travecular bone structure or bone morphology calculated using by HR-pQCT.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The luseogliflozin group: Administer luseogliflozin 2.5 mg a day orally.
Administration of luseogliflozin is increased to 5.0 mg if participants cannot achieve the HbA1c levels less than 7.0 % at each visit of 12, 24, 36 weeks of the study, or a decrease in the HbA1c of more than or equal to 0.5 % compared with those in the previous visit. Maximum dose of luseogliflozin is permitted up to 5.0 mg per day. If participants cannot achieve the HbA1c levels described above, 500 mg of metformin is added in each visit. However, the dosage increase of metformin is permitted by every 250 mg if the participant is already administered metformin more than or equal to 1500 mg per day. Maximum dose of metformin is permitted up to 2250 mg per day.

Interventions/Control_2

The metformin group: Administer metformin 500 mg a day orally in addition to the baseline regime.
Administration of metformin is increased by every 500 mg if participants cannot achieve the HbA1c levels less than 7.0 % at each visit of 12, 24, 36 weeks of the study or a decrease in the HbA1c of more than or equal to 0.5 % compared with those in the previous visit. However, the increase of metformin is permitted by every 250 mg if the participant is already administered metformin more than or equal to 1500 mg per day. Maximum dose of metformin is permitted up to 2250 mg per day.

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

60 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Selection criteria at enrollment into the study
(1) Outpatient
(2) Patient treated with diet therapy alone or with oral anti-diabetic agents including metformin (less than or equal to 1000 mg per day) or/and alpha-glucosidase inhibitors or/and DPP4 inhibitors. The treatment of oral anti-diabetic agents is needed to be not changed within 6 months before enrolled. Patients who have previously treated any anti-diabetic agents excluding metformin, alpha-glucosidase inhibitors, or DPP4 inhibitors can be participated in this study if the treatment was discontinued more than 6 months before enrolled into the study.
(3) Written informed consent

2. Selection criteria at the start of the study
(4) HbA1c level at more than or equal to 7%, and less than 9%.
(5) T-scores of bone mineral density of both lumbar vertebrae and proximal part of femur are over -2.5 S.D. determined by dual energy X-ray absorptiometry.

Key exclusion criteria

(1) Previous history of treatment with SGLT2 inhibitors
(2) Complicated with bone metabolic disorders including osteomalacia, thyroid dysfunction, hyperparathyroidism or hypoparathyroidism that require any medical treatments
(3) Administered any treatments for osteoporosis described below at present or within the past 12 months before enrolled into the study; bisphosphonate, vitamin D preparation, vitamin K preparation, calcium preparation, selective estrogen receptor modulator (SERM), anti-RANKL antibody (denosumab), anti-sclerostin antibody (romosozumab) or parathyroid hormone (teriparatide)
(4) Treated with estrogen or testosterone
(5) Complicated with diabetic retinopathy or/and diabetic neuropathy requiring therapeutic intervention
(6) Sever renal dysfunction with eGFR <30 ml/min/1.73 m2
(7) Anemia with hemoglobin level under 10 g/dL
(8) Complicated with malignancy
(9) Hypersensitivity or allergy to the study drugs including luseogliflozin or metformin
(10) Taking alcohol more than 20 g/day
(11) Smoking cigarette within one year before enrolled into the study
(12) Participated in other clinical trials within 6 months before enrolled into the study
(13) Complicated with chronic liver disease with Child-Pugh score of more than or equal to 6 points.
(14) BMI <18.5 kg/m2
(15) Judged as an unsuitable participant by the researchers.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Horie

Organization

Nagasaki University Hospital

Division name

Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

09568197200

Email

holy197741@me.com


Public contact

Name of contact person

1st name Ichiro
Middle name
Last name Horie

Organization

Nagasaki University Hospital

Division name

Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

09568197200

Homepage URL


Email

holy197741@me.com


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Taisho Toyama Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

JPN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagasaki University Clinical Research Review Board

Address

1-7-1Sakamoto,Nagasaki,Japan Nagasaki

Tel

0968197905

Email

gaibushikin@ml.naasaki-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

長崎大学病院(長崎県)


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Completed

Date of protocol fixation

2019 Year 01 Month 21 Day

Date of IRB

2019 Year 03 Month 11 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2022 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 03 Month 14 Day

Last modified on

2024 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name