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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019253
Receipt No. R000022080
Scientific Title Examination of the effect by taking the sodium glucose transporter 2 inhibitor everyday or only when a patient thinks it to be necessary for type 2 diabetes patients controlled inadequately.
Date of disclosure of the study information 2015/10/06
Last modified on 2017/04/13

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Basic information
Public title Examination of the effect by taking the sodium glucose transporter 2 inhibitor everyday or only when a patient thinks it to be necessary for type 2 diabetes patients controlled inadequately.
Acronym Empagliflozin taken as needed improves patient's therapeutic motivation and quality of life(QOL)with lowering HbA1c and body weight.
Scientific Title Examination of the effect by taking the sodium glucose transporter 2 inhibitor everyday or only when a patient thinks it to be necessary for type 2 diabetes patients controlled inadequately.
Scientific Title:Acronym Empagliflozin taken as needed improves patient's therapeutic motivation and quality of life(QOL)with lowering HbA1c and body weight.
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For type 2 diabetes patients controled inadequately with HbA1c 7.0 to 9.9%,taking oral anti-diabetic drugs to diet and exercise therapy for 12 weekes or more,the sodium glucose transporter 2 inhibitor(Empagliflozin 10mg) will be added everyday or only when a patient thinks it to be necessary.It is intended to be compared the incidence of adverse events such as dehydration,usefulness in grycemic control,effects on therapeutic motivation and quality of life(QOL) between two groups.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.a reduction degree of the HbA1c and fasting plasma glucose 12 or 24 weeks later
Key secondary outcomes 2.changes of dietary intake 12 or 24 weeks later
3.changes of quality of life(QOL) 12 or 24 weeks later
4.a reduction degree of lipid parameters(HDL cholesterol´ŻąLDL cholesterol´Żątriglyceride) and albumin in urine 12 or 24 weeks later
5.changes of body weight,blood pressure, and abdominal circumscription 12 or 24 weeks later

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group which Empagliflozin 10mg every day for 12 weeks or 24 weeks.
Interventions/Control_2 The group which takes Empagliflozin 10mg only when a patient thinks it to be necessary at the maximum 14 times a month for 12 weeks or 24 weeks.
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 (1)Type 2 diabetes patients controlled inadequately with 7.0 to 9.9%.
(2)Patient taking equal or less than three kinds of oral anti-diabete drugs in addition to diet and exercise therapy for 12 weeks or more.
(3)Patients who does not use human GLP-1 analog or insulin.
(4)Adalts who are 20 years or older and 75 years or younger.
(5)Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in examination.
Key exclusion criteria (1) Type 1 diabetes mellitus patients or secondary diabetic mellitus.
(2) Patients who had myocardial infarction within 3 months, or obvious heart failure case.
(3) Patients who had the past hypersensitivity for the used drug.
(4) Patients with diabetic ketoacidosis or diabetic coma or risk of diabetic coma.
(5) Patients with severe liver disease.
(6) Patients with severe renal disease.
(7) Patients with severe pancreas disease.
(8) Patients with hemoglobin (Hb) less than 11 g/dL.
(9) Patient during cancer treatment
(10) Patients that the number of the platelets is less than 100,000 /mm3.
(11) Patients with severe diabetic neuropathy.
(12) Patients having a proliferative retinopathy.
(13) Patients with a serious infectious disease or a serious injury.
(14) Excessive common custom drinker
(15) A pregnant woman or the woman who may be pregnant.
(16) In addition, the patients who will be judged inappropriate by an attendant physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahisa Hirose
Organization Toho University School of Medicine
Division name Division of diabetes, metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Email takahisa.hirose@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Hirose
Organization Toho University School of Medicine
Division name Division of diabetes, metabolism and endocrinology
Zip code
Address 6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3762-4151
Homepage URL
Email takahisa.hirose@med.toho-u.ac.jp

Sponsor
Institute Toho University School of Medicine, Division of diabetes, metabolism and endocrinology
Institute
Department

Funding Source
Organization Toho University School of Medicine
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

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 06 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
2015 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 06 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
2015 Year 10 Month 06 Day
Last modified on
2017 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022080

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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