UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020185 |
|---|---|
| Receipt number | R000023297 |
| Scientific Title | Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4] |
| Date of disclosure of the study information | 2015/12/14 |
| Last modified on | 2019/06/20 13:59:56 |
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Basic information
Public title
Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]
Acronym
Effects of dapagliflozin on renal function [Diamond study-4]
Scientific Title
Effects of dapagliflozin on renal function in patients with type 2 diabetes [Diamond study-4]
Scientific Title:Acronym
Effects of dapagliflozin on renal function [Diamond study-4]
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of dapagliflozin on glomerular filtration rate (GFR)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes from baseline to day 5-9 in GFR evaluated by inulin clearance
Key secondary outcomes
Changes from baseline to month 6-12 in hepatic fat amount
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
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
Male and Female
Key inclusion criteria
Patients who meet all of the following requirements.
1. Patients with type 2 diabetes and HbA1c more than 6.5%
2. Estimated GFR more than 45 mL/min 1.73m2
3. Patients who provide their consent form
Key exclusion criteria
Patients who meet one of the following criteria are ecluded.
1. Patients treated with insulin
2. Patients with unstable angina
3. Patients with severe liver dysfunction (AST >= 100IU/L or ALT >= 100IU/L)
4. Patients with severe renal dysfunction (eGFR < 45 mL/min/1.73m2)
5. Known hypersensitivity to dapagliflozin
6. Patients who are pregnant, possibly pregnant, or nursing
7. A history of traetment with SGLT2 inhibitors including dapagliflozin
8. Patients disqualified by doctor for any reason
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhito Mori |
Organization
Osaka City Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3806
ktmori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhito Mori |
Organization
Osaka City Graduate School of Medicine
Division name
Department of Metabolism, Endocrinology and Molecular Medicine
Zip code
Address
1-4-3, Asahi-machi, Abeno-ku, Osaka
TEL
06-6645-3806
Homepage URL
ktmori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Diamond study group
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
| 2015 | Year | 12 | Month | 14 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023297
