UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023681
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email koyano@juntendo-urayasu.jp

Sponsor
Institute Juntendo University Urayasu Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.