UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032220 |
|---|---|
| Receipt number | R000036742 |
| Scientific Title | Effect of dapagliflozin on bone metabolism in patients with type 2 diabetes |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2018/04/12 18:50:44 |
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Basic information
Public title
Effect of dapagliflozin on bone metabolism in patients with type 2 diabetes
Acronym
Effect of dapagliflozin on bone metabolism
Scientific Title
Effect of dapagliflozin on bone metabolism in patients with type 2 diabetes
Scientific Title:Acronym
Effect of dapagliflozin on bone metabolism
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the influence of dapagliflozin on clinical examination values related to bone metabolism in patients with type 2 diabetes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calcium/phosphate parameter
Key secondary outcomes
glucose and lipid metabolism
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treated with dapagliflozin
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Female type 2 diabetes patients aged 20 years or over and under 70 years old.
Key exclusion criteria
The patients with severe endocrine or metabolic disorders including diabetes ketoacidosis, BMI over 45, post bariatric and metabolic surgery. The patients who have severe liver or cardiovascular disorder, malignant tumor, skeletal diseases. female patients with pregnant or brest-feeding. The patients treated with anti-osteoporosis drugs, gulcocorticoid or diuretics.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Itsuro Endo |
Organization
Tokushima University
Division name
Department of Chronomedicine
Zip code
Address
3-18-15 Kuramoto-cho Tokushima city
TEL
088-633-7120
endoits@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itsuro Endo |
Organization
Tokushima University
Division name
Department of Chronomedicine
Zip code
Address
3-18-15 Kuramoto-cho Tokushima city
TEL
088-633-7120
Homepage URL
endoits@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 15 | 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
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036742
