UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025418
Receipt number R000029259
Scientific Title Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.
Date of disclosure of the study information 2016/12/26
Last modified on 2020/07/14 18:57:22

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Basic information

Public title

Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.

Acronym

Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.

Scientific Title

Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.

Scientific Title:Acronym

Comparing effect of lipid profile and lipid metabolism by SGLT2 inhibitor Empagliflozin in patient with type 2 diabetes.

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to compare a SGLT2 inhibitor Empagliflozin and other anti diabetic agents on lipid parameter and lipid metabolism in patients with type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

sterol 3 fractions

Key secondary outcomes

sterol fractionate
Triglyceride
DUAL-scan


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Empagliflozin group

Interventions/Control_2

control group

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Type 2 diabetes who have inadequate glycemic control(HbA1c between 7.0 and 12.4 %) under medical treatment by dieting and exercise cure and/or drug treatment.
2)Over 20 years old and less than 80 years old
3)Sex unquestioned
4)Patients with no history of cardiovascular disease
5)No treatment or treatment with stable doses of antihypertensive and antiplatelet agents for at least 3 months prior to randomization.
6)The patient who gives a written informed

Key exclusion criteria

1)Type 1 diabetes
2)Liver dysfunction (hepatic enzymes more than three times the upper limit of normal ranges)
3)A pregnant woman and/or a woman under breast-feeding
4)Impaired kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
5)Diabetic proliferative retinopathy
6)The patients who has an anamnesis of hypersensitivity to the ingredient of a trial drug
7)No treatment with Ezetimibe
8)Patient with intolerance of medical reasons by doctor.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Teruo
Middle name
Last name Teruo Joijma

Organization

Dokkyo Medical University

Division name

Department of Endocrinology and Metabolism

Zip code

321-0293

Address

880kita-kobayashi,Mibu,Tochigi321-0293,Japan

TEL

0282-87-2150

Email

jojima@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Teruo
Middle name
Last name Teruo Joijma

Organization

Dokkyo Medical University

Division name

Department of Endocrinology and Metabolism

Zip code

321-0293

Address

880kita-kobayashi,Mibu,Tochigi321-0293,Japan

TEL

0282-87-2150

Homepage URL


Email

jojima@dokkyomed.ac.jp


Sponsor or person

Institute

Department of Endocrinology and Metabolism,
Dokkyo Medical University

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

Dokkyo Medical University

Address

880kita-kobayashi,Mibu,Tochigi,Japan

Tel

0282-87-2275

Email

r-kenkyu@dokkyomed.ac.jp


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

2016 Year 12 Month 26 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

Open public recruiting

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 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

2016 Year 12 Month 26 Day

Last modified on

2020 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029259


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name