UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023681 |
|---|---|
| Receipt number | R000026561 |
| Scientific Title | Evaluation of efficiency and safety of dapagliflozin in treating of type 2 diabetes mellitus |
| Date of disclosure of the study information | 2016/08/20 |
| Last modified on | 2019/02/24 14:45:49 |
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Basic information
Public title
Evaluation of efficiency and safety of dapagliflozin in treating of type 2 diabetes mellitus
Acronym
Efficiency and safety of dapagliflozin
Scientific Title
Evaluation of efficiency and safety of dapagliflozin in treating of type 2 diabetes mellitus
Scientific Title:Acronym
Efficiency and safety of dapagliflozin
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the improvement of blood glucose levels and safety by dapagliflozin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in HbA1c after administration 24 weeks later
Key secondary outcomes
Body weight
Blood pressure
Serum lipid
heart function (LVEF, E/A, E/e', DcT, LVMI,LAV)
Urinary albumin excretion
Urinary L-FABP excretion, serum cystatinC,eGFR
Liver function(AST,ALT,gammaGTP)
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women who were diagnosed with type 2 diabetes mellitus.
Patients who are considered treatment with dapagliflozin is suitable.
Patients with hypertention and/or abnormal electrocardiographic pattern.
eGFR 45 ml/min/1.73 m2 <=
Key exclusion criteria
1.Type 1 diabetes mellitus
2.Diabetic ketoacidosis, diabetic coma, or before coma
3.Sever infection, before and not long after surgery, or patients with sever trauma
4.Left ventricular dysfunction (EF < 50%)
5.Sever liver dysfunction
6.Past history of cerebral infarction, myocardial infarction, and sever heart failure
7.Women suspected of pregnancy or pregnant
8.Patients with a history of use SGLT2 inhibitors
9.Patients who have repeated urinary tract infections
10.Alchole intake excessive
11.Inadequate patients judged by doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime M. Koyano |
Organization
Juntendo University Urayasu Hospital
Division name
Endocrinology and Diabetes
Zip code
Address
2-1-1 Tomioka, Urayasu-city, Chiba, Japan
TEL
047-353-3111
koyano@juntendo-urayasu.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime M. Koyano |
Organization
Juntendo University Urayasu Hospital
Division name
Endocrinology and Diabetes
Zip code
Address
2-1-1 Tomioka, Urayasu-city, Chiba, Japan
TEL
047-353-3111
Homepage URL
koyano@juntendo-urayasu.jp
Sponsor or person
Institute
Juntendo University Urayasu 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
順天堂大学医学部附属浦安病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We clarify the effect of the improvement of blood glucose levels and safety by dapagliflozin.
Management information
Registered date
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026561
