UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057106 |
|---|---|
| Receipt number | R000065132 |
| Scientific Title | Longitudinal Analysis of Bone Microstructural Changes in Type 2 Diabetes Mellitus with the SGLT2 Inhibitor Tofogliflozin (A Study Using Second-Generation High-Resolution Peripheral Quantitative CT) |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/05/01 13:43:28 |
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Basic information
Public title
Longitudinal Analysis of Bone Microstructural Changes in Type 2 Diabetes Mellitus with the SGLT2 Inhibitor Tofogliflozin (A Study Using Second-Generation High-Resolution Peripheral Quantitative CT)
Acronym
Tofogliflozin and HR-pQCT Study
Scientific Title
Longitudinal Analysis of Bone Microstructural Changes in Type 2 Diabetes Mellitus with the SGLT2 Inhibitor Tofogliflozin (A Study Using Second-Generation High-Resolution Peripheral Quantitative CT)
Scientific Title:Acronym
Tofogliflozin and HR-pQCT Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to quantitatively evaluate changes in bone quality and body composition before and after tofogliflozin administration in patients with type 2 diabetes mellitus using HR-pQCT and a body composition analyzer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in estimated bone strength of the radius and tibia calculated by HR-pQCT from the start of tofogliflozin administration to week 48 of treatment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included:
1.Age: Patients with type 2 diabetes mellitus who are 40 years or older at the time of consent.
2.Sex: No restriction.
3.Inpatient/Outpatient Status: No restriction.
4.Glycemic Control: Patients with inadequate glycemic control (HbA1c >= 7.0%) or those with HbA1c >= 6.0% for whom the attending physician considers treatment with an SGLT2 inhibitor appropriate.
5.Prior SGLT2 Inhibitor Use: Patients who have not taken an SGLT2 inhibitor within the past six months.
6.Informed Consent: Patients who have received a sufficient explanation of the study, fully understood it, and provided written consent of their own free will.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study:
1.Implantable Medical Devices: Patients using implantable medical devices such as a cardiac pacemaker.
2.Bone Metabolic Disorders: Patients with bone metabolic diseases requiring therapeutic intervention, including osteomalacia, thyroid dysfunction, hyperparathyroidism, and hypoparathyroidism.
3.Osteoporosis Treatment: Patients who have newly started any of the following osteoporosis treatments within six months prior to obtaining consent or those who are expected to discontinue any of the following treatments between consent acquisition and the end of the study: Bisphosphonates, Vitamin D preparations
Vitamin K preparations, Calcium preparations, Selective estrogen receptor modulators (SERMs), Anti-RANKL antibody (denosumab), Anti-sclerostin antibody (romosozumab), Parathyroid hormone preparations (teriparatide, abaloparatide)
4.Severe Renal Impairment: Patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
5.Active Malignancy: Patients with an active malignant tumor.
6.Participation in Other Trials: Patients who have participated in other clinical trials or research involving investigational drugs or medical devices within six months prior to obtaining consent.
7.Severe Underweight: Patients with severe underweight (BMI < 18.5 kg/m2).
8.Other Conditions: Patients deemed inappropriate for the study by the principal investigator.
Target sample size
30
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
852-8501
Address
1-7-1, Sakamoto, Nagasaki-city
TEL
095-819-7200
horie@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Haraguchi |
Organization
Nagasaki University Hospital
Division name
Endocrinology and Metabolism
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki-city
TEL
095-819-7262
Homepage URL
a-haraguchi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kowa Company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To quantitatively evaluate changes in bone quality and body composition before and after tofogliflozin administration in patients with type 2 diabetes using HR-pQCT and body composition analyzers.
Management information
Registered date
| 2025 | Year | 02 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065132
