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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036202
Receipt No. 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 2020/10/19

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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
Institute Nagasaki University Hospital
Institute
Department

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 Open public recruiting
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
2020 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.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


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