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

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 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


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

Value
https://center6.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