UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016921 |
|---|---|
| Receipt number | R000019640 |
| Scientific Title | Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes |
| Date of disclosure of the study information | 2015/03/26 |
| Last modified on | 2015/03/26 12:34:16 |
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Basic information
Public title
Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Acronym
Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Scientific Title
Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Scientific Title:Acronym
Efficacy of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of SGLT2 inhibitors on bone mineral density in patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bone mineral density compared to that of a young adult mean
Key secondary outcomes
Hemoglobin A1c level, body mass index, renal function parameters in blood and urine and serum lipid profiles
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Luseogliflozin
Interventions/Control_2
Dapagliflozin
Interventions/Control_3
Tofogliflozin
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria
Complicated severe nephropathy.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Aichi Medical University
Division name
Medical Clinic
Zip code
Address
2-12-1, Higashisakura, Higashi-ku, Nagoya
TEL
052-931-2261
info@tonyo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Aichi Medical University
Division name
Medical Clinic
Zip code
Address
2-12-1, Higashisakura, Higashi-ku, Nagoya
TEL
052-931-2261
Homepage URL
info@tonyo.jp
Sponsor or person
Institute
Akishima Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
医療法人社団あきしまクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 26 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 24 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2015 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019640
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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